SecProbe.io

CORRESP
 1
 filename1.htm

 November 21, 2025

 VIA EDGAR

 U.S. Securities and Exchange Commission

 Division of Corporation Finance

 100 F Street, NE

 Washington, D.C. 20549

 Attn: Lauren Nguyen, Office Chief
Juan Grana, Staff Attorney

 Re:
 Predictive Oncology Inc.

 Registration Statement on Form S-3
 Filed October 22, 2025
 File No. 333-291021
 Acceleration Request
 Requested Date: November 25, 2025
 Requested Time: 4:00 P.M. Eastern Time

 Ladies and Gentlemen:

 Pursuant to Rule 461 under the Securities Act of 1933, as amended, Predictive
Oncology Inc. (the " Registrant ") hereby requests that the above-referenced Registration Statement on Form S-3
(File No. 333-291021) (the " Registration Statement ") be declared effective at the "Requested Date"
and "Requested Time" set forth above, or as soon as practicable thereafter.

 We request that we be notified of the effectiveness of the Registration
Statement by telephone to Era Anagnosti of DLA Piper LLP (US) at (202) 799-4087. Thank you for your assistance.

 Very truly yours,

 Predictive Oncology Inc.

 /s/ Josh Blacher

 Josh Blacher

 Chief Financial Officer

 cc:

 Raymond Vennare (Chief Executive Officer, Predictive Oncology Inc.)
 Sara Turken (General Counsel, Predictive Oncology Inc.)
 Era Anagnosti (DLA Piper LLP (US))

CORRESP
 1
 filename1.htm

 November 20, 2025

 VIA EDGAR

 U.S. Securities and Exchange Commission

 Division of Corporation Finance

 100 F Street, NE

 Washington, D.C. 20549

 Attn: Lauren Nguyen, Office Chief
Juan Grana, Staff Attorney

 Re:
 Predictive Oncology Inc.

 Registration Statement on Form S-3
 Filed October 22, 2025
 File No. 333-291022
 Acceleration Request
 Requested Date: November 21, 2025
 Requested Time: 4:00 P.M. Eastern Time

 Ladies and Gentlemen:

 Pursuant to Rule 461 under the Securities Act of 1933, as amended, Predictive
Oncology Inc. (the " Registrant ") hereby requests that the above-referenced Registration Statement on Form S-3
(File No. 333-291022) (the " Registration Statement ") be declared effective at the "Requested Date"
and "Requested Time" set forth above, or as soon as practicable thereafter.

 We request that we be notified of the effectiveness of the Registration
Statement by telephone to Era Anagnosti of DLA Piper LLP (US) at (202) 799-4087. Thank you for your assistance.

 Very truly yours,

 Predictive Oncology Inc.

 /s/ Josh Blacher

 Josh Blacher

 Chief Financial Officer

 cc:

 Raymond Vennare (Chief Executive Officer, Predictive Oncology Inc.)
 Sara Turken (General Counsel, Predictive Oncology Inc.)
 Era Anagnosti (DLA Piper LLP (US))

<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 July 24, 2025

Josh Blacher
Interim Chief Financial Officer
Predictive Oncology Inc.
91 43rd Street, Suite 110
Pittsburgh, PA 15201

 Re: Predictive Oncology Inc.
 Registration Statement on Form S-1
 Filed July 18, 2025
 File No. 333-288782
Dear Josh Blacher:

 This is to advise you that we have not reviewed and will not review your
registration
statement.

 Please refer to Rules 460 and 461 regarding requests for acceleration.
We remind you
that the company and its management are responsible for the accuracy and
adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action
by the staff.

 Please contact Margaret Sawicki at 202-551-7153 with any questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Industrial
Applications and
 Services
cc: Amanda Maki, Esq.
</TEXT>
</DOCUMENT>

CORRESP
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 PREDICTIVE ONCOLOGY INC.

 91 43rd Street, Suite 110

 Pittsburgh, PA 15201

 July 24, 2025

 VIA EDGAR

 United States Securities and Exchange Commission

 Division of Corporation Finance

 100 F Street, N.E.

 Washington, D.C. 20549

 Attention: Margaret Sawicki

 Re: Predictive Oncology Inc.

 Acceleration Request for Registration Statement
on Form S-1

 File No. 333-288782

 Requested Date: July 28, 2025

 Requested Time: 5:00 P.M. Eastern Time

 Ladies and Gentlemen:

 Pursuant to Rule 461 under the Securities Act of 1933,
as amended, Predictive Oncology Inc. (the " Registrant ") hereby requests that the above-referenced Registration
Statement on Form S-1 (File No. 333-288782) (the " Registration Statement ") be declared effective at the "Requested
Date" and "Requested Time" set forth above, or as soon as practicable thereafter, or at such later time as the Registrant
or its counsel may orally request (the " Registration Statement Acceleration Request ") via telephone call to
the staff (the " Staff ") of the Division of Corporation Finance of the Securities and Exchange Commission (the
" Commission "). The Registrant hereby authorizes Amanda Maki of DLA Piper LLP (US), counsel for the Registrant,
to make such request on the Registrant's behalf.

 We request that we be notified of the effectiveness of the Registration
Statement by telephone to Amanda Maki at 713-425-8461. Thank you for your assistance.

 Very truly yours,

 /s/ Josh Blacher

 Josh Blacher

 Interim Chief Financial Officer

 cc: Raymond Vennare (Chief Executive Officer, Predictive Oncology Inc.)

 Sara Turken (General Counsel, Predictive Oncology Inc.)

 Amanda Maki (DLA Piper LLP (US))

August 21, 2024
Raymond Vennare
Chief Executive Officer
Predictive Oncology Inc.
91 43rd Street, Suite 110
Pittsburgh, Pennsylvania 15201
Re:Predictive Oncology Inc.
Registration Statement on Form S-3
Filed August 15, 2024
File No. 333-281579
Dear Raymond Vennare:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that
the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Margaret Sawicki at 202-551-7153 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:Alan Seem, Esq.

CORRESP
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PREDICTIVE ONCOLOGY INC.

91 43rd Street, Suite 110

Pittsburgh, PA 15201

August 21, 2024

VIA EDGAR

United States Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, D.C. 20549

Attention: Ms. Jane Park, Staff Attorney

    Re:
    Predictive Oncology Inc.

    Acceleration Request for Registration Statement on Form S-3, as amended

    File No. 333-281579

    Requested Date: August 23, 2024

    Requested Time: 4:05 P.M. Eastern Time

Ladies and Gentlemen:

Pursuant to Rule 461 under the Securities Act of 1933,
as amended, Predictive Oncology Inc. (the “Registrant”) hereby requests that the above-referenced Registration
Statement on Form S-3 (File No. 333-281579) (the “Registration Statement”) be declared effective at the “Requested
Date” and “Requested Time” set forth above, or as soon as practicable thereafter, or at such later time as the Registrant
or its counsel may orally request (the “Registration Statement Acceleration Request”) via telephone call to
the staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the
“Commission”). The Registrant hereby authorizes Alan Seem of DLA Piper LLP (US), counsel for the Registrant,
to make such request on the Registrant’s behalf.

The Registrant acknowledges that the Registrant and
its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence
of action by the staff.

We request that we be notified of the effectiveness of the Registration
Statement by telephone to Alan Seem of DLA Piper LLP (US) at 650-833-2050. Thank you for your assistance.

    Very truly yours,

    /s/ Raymond Vennare

    Raymond Vennare

    Chief Executive Officer

    cc:
    Raymond Vennare (Chief Executive Officer, Predictive Oncology Inc.)

    Josh Blacher (Interim Chief Financial Officer, Predictive Oncology Inc.)

    Alan Seem (DLA Piper LLP (US))

CORRESP
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PREDICTIVE ONCOLOGY INC.

91 43rd Street, Suite 110

Pittsburgh, PA 15201

May 20, 2024

VIA EDGAR

United States Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, D.C. 20549

Attention: Ms. Jane Park, Staff Attorney

  Re:
  Predictive Oncology Inc.

  Acceleration Request for Registration Statement
on Form S-3, as amended

  File No. 333-279123

  Requested Date: May 21, 2024

  Requested Time: 5:00 P.M. Eastern Time

Ladies and Gentlemen:

Pursuant to Rule 461 under the Securities Act of 1933,
as amended, Predictive Oncology Inc. (the “Registrant”) hereby requests that the above-referenced Registration
Statement on Form S-3 (File No. 333-279123) (the “Registration Statement”) be declared effective at the “Requested
Date” and “Requested Time” set forth above, or as soon as practicable thereafter, or at such later time as the Registrant
or its counsel may orally request (the “Registration Statement Acceleration Request”) via telephone call to
the staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the
“Commission”). The Registrant hereby authorizes Alan Seem of DLA Piper LLP (US), counsel for the Registrant,
to make such request on the Registrant’s behalf.

We request that we be notified of the effectiveness of the Registration
Statement by telephone to Alan Seem of DLA Piper LLP (US) at 650-833-2050, or in his absence, Amanda Maki of DLA Piper LLP (US) at 713-425-8461.
Thank you for your assistance.

  Very truly yours,

  /s/ Raymond Vennare

  Raymond Vennare

  Chief Executive Officer

  cc:
  Raymond Vennare (Chief Executive Officer, Predictive Oncology Inc.)

  Josh Blacher (Interim Chief Financial Officer, Predictive
Oncology Inc.)

  Alan. Seem (DLA Piper LLP (US))

  Amanda Maki (DLA Piper LLP (US))

United States securities and exchange commission logo
May 13, 2024
Raymond Vennare
Chief Executive Officer
Predictive Oncology Inc.
91 43rd Street, Suite 110
Pittsburgh, Pennsylvania 15201
Re:Predictive Oncology Inc.
Registration Statement on Form S-3
Filed May 6, 2024
File No. 333-279123
Dear Raymond Vennare:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Jane Park at 202-551-7439 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:       Alan Seem, Esq.

CORRESP
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Predictive Oncology, Inc.

2915 Commers Drive, Suite 900

Eagan, MN 55121

October 11, 2022

VIA EDGAR

United States Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, DC 20549

Attention: Benjamin Richie

    Re:
    Predictive Oncology, Inc.

    Registration Statement on Form S-1

    File No. 333-267689

Ladies and Gentlemen:

Pursuant to Rule 461 under the Securities Act
of 1933, as amended, the undersigned registrant hereby requests that the Securities and Exchange Commission take appropriate action to
cause the above-referenced Registration Statement on Form S-1 (File No. 333-267689) (the “Registration Statement”) to become
effective at 4:30 p.m. Eastern Time on October 13, 2022, or as soon thereafter as is practicable.

Once the Registration Statement has been declared effective, please
orally confirm that event with Andy Tataryn of Maslon LLP, counsel to the registrant, at (612) 672-8327.

Very truly yours,

PREDICTIVE ONCOLOGY, INC.

By:  /s/ Bob Myers

  Bob Myers

  Chief Financial Officer

cc: Andrew Tataryn, Maslon LLP

United States securities and exchange commission logo
October 6, 2022
Bob Myers
Chief Financial Officer
Predictive Oncology Inc.
2915 Commers Drive, Suite 900
Eagan, Minnesota 55121
Re:Predictive Oncology Inc.
Registration Statement on Form S-1
Filed September 30, 2022
File No. 333-267689
Dear Bob Myers:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Benjamin Richie at 202-551-7857 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:       Andrew Tataryn

United States securities and exchange commission logo
May 3, 2021
Bob Myers
Chief Financial Officer
Predictive Oncology Inc.
2915 Commers Drive, Suite 900
Eagan, Minnesota 55121
Re:Predictive Oncology Inc.
Registration Statement on Form S-3
Filed April 28, 2021
File No. 333-255582
Dear Mr. Myers:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Martin R. Rosenbaum, Esq.

CORRESP
1
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May 3, 2021

BY EDGAR

United States Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

Attention: Chris Edwards

      Re:
    Predictive Oncology Inc.

    Registration Statement on Form S-3

    File No. 333- 255582

    Request for Acceleration

Ladies and Gentlemen:

In accordance with Rules 460 and 461 of the
General Rules and Regulations under the Securities Act of 1933, as amended, Predictive Oncology Inc., a Delaware corporation (the
“Registrant”), hereby requests that the effectiveness of the above-referenced Registration Statement on Form
S-3 (the “Registration Statement”), be accelerated so that it will be declared effective at 5:00 p.m. Eastern
Standard Time on May 5, 2021, or as soon thereafter as practicable.

    Very truly yours,

    Predictive Oncology Inc.

    By:
    /s/ Bob Myers

    Name: Bob Myers

    Title: Chief Financial Officer

CORRESP
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March 18, 2021

BY EDGAR

United States Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

Attention: Dylan Hagius

    Re:
    Predictive Oncology Inc.

    Registration Statement on Form S-3

    File No. 333- 254309

    Request for Acceleration

Ladies and Gentlemen:

In accordance with
Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Predictive Oncology Inc., a Delaware
corporation (the “Registrant”), hereby requests that the effectiveness of the above-referenced Registration
Statement on Form S-3 (the “Registration Statement”), be accelerated so that it will be declared effective at
5:00 p.m. Eastern Standard Time on March 23, 2021, or as soon thereafter as practicable.

    Very truly yours,

    Predictive Oncology Inc.

    By:
    /s/ Bob Myers

    Name: Bob Myers

    Title: Chief Financial Officer

United States securities and exchange commission logo
March 17, 2021
Bob Myers
Chief Financial Officer
Predictive Oncology Inc.
2915 Commers Drive, Suite 900
Eagan, Minnesota 55121
Re:Predictive Oncology Inc.
Registration Statement on Form S-3
Filed March 15, 2021
File No. 333-254309
Dear Mr. Myers:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Dillon Hagius at 202-551-7976 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Martin Rosenbaum

CORRESP
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February 5, 2021

BY EDGAR

United States Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

Attention: Mr. Alan Campbell

    Re:
    Predictive Oncology Inc.

    Registration Statement on Form S-3

    File No. 333- 252585

    Request for Acceleration

Ladies and Gentlemen:

In accordance with Rule 461 of the General Rules
and Regulations under the Securities Act of 1933, as amended, Predictive Oncology Inc., a Delaware corporation (the “Registrant”),
hereby requests that the effectiveness of the above-referenced Registration Statement on Form S-1 (the “Registration Statement”),
be accelerated so that it will be declared effective at 5:00 p.m. Eastern Standard Time on February 9, 2021, or as soon thereafter
as practicable.

     Very truly yours,

     Predictive Oncology Inc.

     By:
    /s/ Bob Myers

     Title:
    Chief Financial Officer

CORRESP
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February 5, 2021

BY EDGAR

United States Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

Attention: Mr. Alan Campbell

    Re:
    Predictive Oncology Inc.

    Registration Statement on Form S-3

    File No. 333- 252584

    Request for Acceleration

Ladies and Gentlemen:

In accordance with Rule 461 of the General Rules
and Regulations under the Securities Act of 1933, as amended, Predictive Oncology Inc., a Delaware corporation (the “Registrant”),
hereby requests that the effectiveness of the above-referenced Registration Statement on Form S-1 (the “Registration Statement”),
be accelerated so that it will be declared effective at 5:00 p.m. Eastern Standard Time on February 9, 2021, or as soon thereafter
as practicable.

    Very truly yours,

    Predictive Oncology Inc.

    By:
    /s/ Bob Myers

    Title:
    Chief Financial Officer

United States securities and exchange commission logo
February 4, 2021
Bob Myers
Chief Financial Officer
Predictive Oncology Inc.
2915 Commers Drive, Suite 900
Eagan, Minnesota 55121
Re:Predictive Oncology Inc.
Registration Statement on Form S-1
Filed January 29, 2021
File No. 333-252584
Dear Mr. Myers:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Alan Campbell at 202-551-4224 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Martin R. Rosenbaum, Esq.

CORRESP
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July 17, 2020

BY EDGAR

United States Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

Attention: Mr. Jason Drory

Re:   Predictive
Oncology Inc.

Registration Statement on Form S-3

File No. 333- 239851

Request for Acceleration

Ladies and Gentlemen:

In accordance with Rule 461 of the General Rules and Regulations
under the Securities Act of 1933, as amended, Predictive Oncology Inc., a Delaware corporation (the “Registrant”),
hereby requests that the effectiveness of the above-referenced Registration Statement on Form S-3 (the “Registration Statement”),
be accelerated so that it will be declared effective at 5:00 p.m. Eastern Standard Time on July 21, 2020, or as soon thereafter
as practicable.

Very truly yours,

Predictive Oncology Inc.

By:   /s/ Bob Myers                                

Name: Bob Myers

Title: Chief Financial
Officer

United States securities and exchange commission logo
July 17, 2020
Carl Schwartz
Chief Executive Officer
Predictive Oncology Inc.
2915 Commers Drive, Suite 900
Eagan, MN 55121
Re:Predictive Oncology Inc.
Registration Statement on Form S-3
Filed July 14, 2020
File No. 333-239851
Dear Mr. Schwartz:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Jason L. Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Bradley L. Yenter, Esq.

CORRESP
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July 1, 2020

BY EDGAR

United States Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

Attention: Ms. Laura Crotty

Re:  Predictive Oncology Inc.

                                                                                Registration Statement on Form S-1

                                                                                File No. 333-239408

                                                                                Request for Acceleration

Ladies and Gentlemen:

In accordance with Rule 461 of the General Rules and Regulations
under the Securities Act of 1933, as amended, Predictive Oncology Inc., a Delaware corporation (the “Registrant”),
hereby requests that the effectiveness of the above-referenced Registration Statement on Form S-1 (the “Registration Statement”),
be accelerated so that it will be declared effective at 5:00 p.m. Eastern Standard Time on July 6, 2020, or as soon thereafter
as practicable.

Very truly yours,

Predictive Oncology Inc.

By: /s/ Bob Myers

        Name: Bob Myers

        Title: Chief Financial Officer

United States securities and exchange commission logo
June 30, 2020
Bob Myers
Chief Financial Officer
Predictive Oncology Inc.
2915 Commers Drive, Suite 900
Eagan, Minnesota 55121
Re:Predictive Oncology Inc.
Registration Statement on Form S-1
Filed June 24, 2020
File No. 333-239408
Dear Mr. Myers:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Laura Crotty at (202) 551-7614 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Bradley L. Yenter

United States securities and exchange commission logo
June 22, 2020
Bob Myers
Chief Financial Officer
Predictive Oncology Inc.
2915 Commers Drive, Suite 900
Eagan, MN 55121
Re:Predictive Oncology Inc.
Registration Statement on Form S-1
Filed June 16, 2020
File No. 333-239207
Dear Mr. Myers:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Christine Westbrook at 202-551-5019 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Bradley L. Yenter, Esq.

CORRESP
1
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June 22, 2020

BY EDGAR

United States Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

Attention: Ms. Christine Westbrook

    Re:
    Predictive Oncology Inc.

    Registration Statement on Form S-1

    File No. 333-239207

    Request for Acceleration

Ladies and Gentlemen:

In accordance with Rule 461 of the General
Rules and Regulations under the Securities Act of 1933, as amended, Predictive Oncology Inc., a Delaware corporation (the “Registrant”),
hereby requests that the effectiveness of the above-referenced Registration Statement on Form S-1 (the “Registration Statement”),
be accelerated so that it will be declared effective at 5:00 p.m. Eastern Standard Time on June 24, 2020, or as soon thereafter
as practicable.

    Very truly yours,

    Predictive Oncology Inc.

    By:
     /s/ Bob Myers

    Name: Bob Myers

    Title: Chief Financial Officer

April 13, 2020
Bob Myers
Chief Financial Officer
Predictive Oncology Inc.
2915 Commers Drive, Suite 900
Eagan, Minnesota 55121
Re:Predictive Oncology Inc.
Registration Statement on Form S-3
Filed April 6, 2020
File No. 333-237581
Dear Mr. Myers:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Chris Edwards at (202) 551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Martin R. Rosenbaum, Esq.

CORRESP
1
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April 13, 2020

BY EDGAR

United States Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

Attention: Irene Paik

    Re:
    Predictive Oncology Inc.

    Registration Statement on Form S-3

    File No. 333-237581

    Request for Acceleration

Ladies and Gentlemen:

In accordance with Rule 461 of the General
Rules and Regulations under the Securities Act of 1933, as amended, Predictive Oncology Inc., a Delaware corporation (the “Registrant”),
hereby requests that the effectiveness of the above-referenced Registration Statement on Form S-3 (the “Registration Statement”),
be accelerated so that it will be declared effective at 5:00 p.m. Eastern Standard Time on April 15, 2020, or as soon thereafter
as practicable.

    Very truly yours,

    Predictive Oncology Inc.

    By:
    /s/ Bob Myers

    Name: Bob Myers

    Title: Chief Financial Officer

CORRESP
1
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December 17, 2019

BY EDGAR

United States Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

Attention: Irene Paik

Re:         Predictive Oncology Inc.

Registration Statement on Form S-3

File No. 333-235441

Request for Acceleration

Ladies and Gentlemen:

In accordance with Rule 461 of the General Rules and Regulations
under the Securities Act of 1933, as amended, Predictive Oncology Inc., a Delaware corporation (the “Registrant”),
hereby requests that the effectiveness of the above-referenced Registration Statement on Form S-1 (the “Registration Statement”),
be accelerated so that it will be declared effective at 3:00 p.m. Eastern Standard Time on December 20, 2019, or as soon thereafter
as practicable.

    Very truly yours,

    Predictive Oncology Inc.

    By:
    /s/ Bob Myers

    Name: Bob Myers

    Title: Chief Financial Officer

December 17, 2019
Bob Myers
Chief Financial Officer
Predictive Oncology Inc.
2915 Commers Drive, Suite 900
Eagan, Minnesota 55121
Re:Predictive Oncology Inc.
Registration Statement on Form S-3
Filed December 10, 2019
File No. 333-235441
Dear Mr. Myers:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Irene Paik at 202-551-6553 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Martin R. Rosenbaum, Esq.

CORRESP
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December 17, 2019

BY EDGAR

United States Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

Attention: Paul Fischer, Esq.

    Re:
    Predictive Oncology Inc.

    Registration Statement on Form S-3

    File No. 333-234073

    Request for Acceleration

Ladies and Gentlemen:

In accordance with Rule 461 of the General
Rules and Regulations under the Securities Act of 1933, as amended, Predictive Oncology Inc., a Delaware corporation (the “Registrant”),
hereby requests that the effectiveness of the above-referenced Registration Statement on Form S-1 (the “Registration Statement”),
be accelerated so that it will be declared effective at 3:00 p.m. Eastern Standard Time on December 20, 2019, or as soon thereafter
as practicable.

    Very truly yours,

    Predictive Oncology Inc.

    By:
    /s/ Bob Myers

    Name: Bob Myers

    Title: Chief Financial Officer

CORRESP
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November 15, 2019

BY EDGAR

United States Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

Attention: Mr. Paul Fischer, Esq.

    Re:
    Predictive Oncology Inc.

    Registration Statement on Form S-1

    File No. 333-234366

    Request for Acceleration

Ladies and Gentlemen:

In accordance with Rule 461 of the General Rules and Regulations
under the Securities Act of 1933, as amended, Predictive Oncology Inc., a Delaware corporation (the “Registrant”),
hereby requests that the effectiveness of the above-referenced Registration Statement on Form S-1 (the “Registration Statement”),
be accelerated so that it will be declared effective at 3:00 p.m. Eastern Standard Time on November 19, 2019, or as soon thereafter
as practicable.

    Very truly yours,

    Predictive Oncology Inc.

    By:
    /s/ Bob Myers

    Name: Bob Myers

    Title: Chief Financial Officer

CORRESP
1
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PREDICTIVE ONCOLOGY INC.

November 15, 2019

VIA EDGAR

Paul Fischer, Esq.

Division of Corporation Finance

Office of Life Sciences

Securities and Exchange Commission

100 F Street NE

Washington, D.C. 20549

Re:  Predictive Oncology Inc.

    Registration Statement on Form S-1

    Filed: October 30, 2019

    File No.: 333-234366

Dear Mr. Fischer:

Filed herewith is Amendment No. 1 to the Company’s
Registration Statement on Form S-1 filed via EDGAR on October 30, 2019 (the “Form S-1”). We are writing to submit
the response of Predictive Oncology Inc. (the “Company”) to the comments of the staff (the “Staff”)
of the Division of Corporation Finance of the United States Securities and Exchange Commission (the “Commission”)
set forth in its comment letter, dated November 13, 2019, relating to the Form S-1. Please note that, for the Staff’s convenience,
we have recited the Staff’s comments in italicized type below and have followed the comments with the Company’s response.

Form S-1 filed October 30, 2019

Additional Risk Factor, page 6

1.  We note the additional risk factor you have provided addressing your Exclusive
Forum Provision under Delaware law. To avoid the possibility of any confusion, please revise sentence two of the risk factor to
clarify, if true, that your exclusive forum selection provision does not apply to actions arising under the Securities Act of
1933, as amended, or the Securities Exchange Act of 1934, as amended.

Response:
We have clarified the risk factor accordingly, as shown on page 6 of Amendment No. 1.

* * *

    1

Should you have any additional comments or questions,
please contact the undersigned at (651) 389-4806 or Martin Rosenbaum, Esq. of Maslon LLP, counsel to the Company, at (612) 672-8326.

    Sincerely,

    /s/ Bob Myers

    Bob Myers

    Chief Financial Officer of Predictive Oncology Inc.

cc:  Carl Schwartz, Chief Executive Officer, Predictive Oncology Inc.

    Martin R. Rosenbaum, Esq., Maslon LLP

2

November 13, 2019
Bob Myers
Chief Financial Officer
Predictive Oncology Inc.
2915 Commers Drive, Suite 900
Eagan, MN 55121
Re:Predictive Oncology Inc.
Registration Statement on Form S-1
Filed October 30, 2019
File No. 333-234366
Dear Mr. Myers:
            We have limited our review of your registration statement to those issues we have
addressed in our comment.
            Please respond to this letter by amending your registration statement and providing the
requested information.  If you do not believe our comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
            After reviewing any amendment to your registration statement and the information you
provide in response to this comment, we may have additional comments.
Form S-1 filed on October 30, 2019
Additional Risk Factor, page 6
1.We note the additional risk factor you have provided addressing your Exclusive Forum
Provision under Delaware law. To avoid the possibility of any confusion, please revise
sentence two of the risk factor to clarify, if true, that your exclusive forum selection
provision does not apply to actions arising under the Securities Act of 1933, as amended,
or the Securities Exchange Act of 1934, as amended.
            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
            Refer to Rules 460 and 461 regarding requests for acceleration.  Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration

 FirstName LastNameBob Myers
 Comapany NamePredictive Oncology Inc.
 November 13, 2019 Page 2
 FirstName LastName
Bob Myers
Predictive Oncology Inc.
November 13, 2019
Page 2
statement.
            Please contact Paul Fischer at 202-551-3415, or Mary Beth Breslin at 202-551-3625, with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Martin Rosenbaum, Esq.

October 16, 2019
Bob Myers
Chief Financial Officer
Predictive Oncology Inc.
2915 Commers Drive, Suite 900
Eagan, MN 55121
Re:Predictive Oncology Inc.
Registration Statement on Form S-3
Filed October 3, 2019
File No. 333-234073
Dear Mr. Myers:
            We have limited our review of your registration statement to those issues we have
addressed in our comment. Please respond to this letter by amending your registration statement
and providing the requested information.  If you do not believe our comment applies to your
facts and circumstances or do not believe an amendment is appropriate, please tell us why in
your response.
            After reviewing any amendment to your registration statement and the information you
provide in response to this comment, we may have additional comments.
Registration Statement on Form S-3
Description of Capital Stock, page 7
1.We note that your forum selection provision in the Certificate of Incorporation filed as
Exhibit 3.1 identifies the Court of Chancery of the State of Delaware as the exclusive
forum for certain litigation, including any "derivative action." Please disclose whether this
provision applies to actions arising under the Securities Act or the Exchange Act. In that
regard, we note that Section 27 of the Exchange Act creates exclusive federal jurisdiction
over all suites brought to enforce any duty or liability created the the Exchange Act or the
rules and regulations thereunder, and Section 22 of the Securities Act creates concurrent
jurisdiction for federal ans state courts over all suites brought to enforce any duty or
liability created by the Securities Act or the rules and regulations thereunder. If the
provision applies to Securities Act claims, please revise your prospectus to state that there
is uncertainty as to whether a court would enforce such provision and investors cannot
waive compliance with the federal securities laws and the rules and regulations
thereunder. If the provision does not apply to actions arising under the Securities Act or

 FirstName LastNameBob Myers
 Comapany NamePredictive Oncology Inc.
 October 16, 2019 Page 2
 FirstName LastName
Bob Myers
Predictive Oncology Inc.
October 16, 2019
Page 2
Exchange Act, please also tell us how you will inform investors in future filings that the
provision does not apply to any actions arising under the Securities Act or Exchange Act.
            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
            Refer to Rules 460 and 461 regarding requests for acceleration.  Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
            Please contact Paul Fischer, Staff Attorney, at 202-551-3415, or Mary Beth Breslin,
Legal Branch Chief, at 202-551-3625, with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Martin Rosenbaum

CORRESP
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Skyline Medical Inc.

2915 Commers Drive, Suite 900

Eagan, Minnesota 55121

December 20, 2017

BY EDGAR

United States Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

Attention: Ms. Heather Percival

    Re:
    Skyline Medical Inc.

    Registration Statement on Form S-3

    File No. 333-221966

    Request for Acceleration

Ladies and Gentlemen:

In accordance with Rule 461 of the General Rules and Regulations
under the Securities Act of 1933, as amended, Skyline Medical Inc., a Delaware corporation (the “Registrant”),
hereby requests that the effectiveness of the above-referenced Registration Statement on Form S-3 (the “Registration Statement”),
be accelerated so that it will be declared effective at 3:00 p.m. Eastern time on December 21, 2017, or as soon thereafter as practicable.

    Very truly yours,

    Skyline Medical Inc.

    By:
    /s/ Bob Myers

    Name: Bob Myers

    Title: Chief Financial Officer

Mail Stop 3030
December 20 , 2017

Via E -mail
Bob Myers
Chief Financial Officer
Skyline Medical Inc.
2915 Commers Drive, Suite 900
Eagan, Minnesota 55121

Re: Skyline Medical Inc.
  Registration Statement on Form  S-3
Filed  December 8, 2017
  File No.  333-221966

Dear Mr. Myers :

This is to advise you that we have not  reviewed and will not review your registration
statement .

Please refer to Rules 460 and 461 regarding requests for acceleration.  We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.

Please  contact Heather Percival  at (202) 551 -3498  with any questions.

Sincerely,

 /s/ Heather Percival for

Amanda Ravitz
Assistant Director
Office of Electronics and Machinery

cc: Martin Rosenbaum, Esq.
Maslon LLP

CORRESP
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filename1.htm

Skyline Medical Inc.

2915 Commers Drive, Suite 900

Eagan, Minnesota 55121

October 3, 2016

BY EDGAR

United States Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

Attention: Ms. Heather Percival

    Re:
    Skyline Medical Inc.

    Registration Statement on Form S-3

    File No. 333-213766

    Request for Acceleration

Ladies and Gentlemen:

In accordance with Rule 461 of the General
Rules and Regulations under the Securities Act of 1933, as amended, Skyline Medical Inc., a Delaware corporation (the “Registrant”),
hereby requests that the effectiveness of the above-referenced Registration Statement on Form S-3 (the “Registration Statement”),
be accelerated so that it will be declared effective at 3:00 p.m. Eastern time on October 4, 2016, or as soon thereafter as practicable.

The Registrant hereby acknowledges that:

(i)
should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated
authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect
to the Registration Statement;

(ii)
the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement
effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the
Registration Statement; and

(iii)
the Registrant may not assert staff comments and the declaration of the effectiveness as a defense in any proceeding initiated
by the Commission or any person under the federal securities laws of the United States.

[Signature page follows]

    Very truly yours,

    Skyline Medical Inc.

    By: /s/ Bob Myers

    Name: Bob Myers

    Title: Chief Financial Officer

[Signature Page to Acceleration Request]

Mail Stop 3030
September 30, 2016

Via E -mail
Bob Myers
Chief Financial Officer
Skyline Medical Inc.
2915 Commers Drive, Suite 900
Eagan, Minnesota 55121

Re: Skyline Medical Inc.
  Registration Statement on Form S-3
Filed  September 23, 2016
  File No.  333-213766

Dear Mr. Myers :

This is to advise you that we have not  reviewed and will not review your registration
statement .

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 193 3 and
all applicable Securities  Act rules require.   Since the company and its management are  in
possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

In the event you request acceleration of the effective date of the pending regist ration
statement , please provide  a written statement from the company acknowledging that:

 should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commission from taking any action wit h respect
to the filing;

 the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in the filing; and

 the company  may not assert staff comments and the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.

Bob Myers
Skyline Medical Inc.
September 30, 2016
Page 2

 Please refer to Rules 460 and 461 regarding requests for  acceleration .  We will consider a
written request for acceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of their respective responsibilities under
the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the registered securities .

Please  contact Heather Percival  at (202) 551 -3498  with any questions.

Sincerely,

 /s/ Heather Percival for

Amanda Ravitz
Assistant Director
Office of Electronics and Machinery

cc:  Martin R. Rosenbaum, Esq.
 Maslon LLP

CORRESP
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April 1, 2016

Skyline Medical Inc.

2915 Commers Drive, Suite 900

Eagan, Minnesota 55121

BY EDGAR

United States Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

Attention: Mr. Brian Soares

Re:  Skyline Medical Inc.
                                                                                                                                   Registration

Statement on Form S-4

File No. 333-210398

Request for Acceleration

Ladies and Gentlemen:

In accordance with Rule 461 of the General Rules and Regulations
under the Securities Act of 1933, as amended, Skyline Medical Inc., a Delaware corporation (the “Registrant”),
hereby requests that the effectiveness of the above-referenced Registration Statement on Form S-4 (the “Registration Statement”),
be accelerated so that it will be declared effective at 9:00 a.m. Eastern time on April 5, 2016, or as soon thereafter as practicable.

The Registrant hereby acknowledges that:

(i)
should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated
authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect
to the Registration Statement;

(ii)
the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement
effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the
Registration Statement; and

(iii)
the Registrant may not assert staff comments and the declaration of the effectiveness as a defense in any proceeding initiated
by the Commission or any person under the federal securities laws of the United States.

[Signature page follows]

Very truly yours,

Skyline Medical Inc.

By:    /s/ Joshua Kornberg

Name: Joshua Kornberg

Title: Chief Executive Officer

Mail Stop 3030
March 30, 2016

Via E -Mail
Joshua Kornberg
President, Chief Executive Officer and Interim Chairman of the Board
Skyline Medical Inc.
2915 Commers Drive, Suite 90 0
Eagan,  MN 55121

Re: Skyline  Medical Inc.
  Registration Statement on Form S-4
Filed  March 25, 2016
  File No.  333-210398

Dear Mr. Kornberg :

This is to advise you that we have not  reviewed and will not review your registration
statement .

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 193 3 and
all applicable Securities  Act rules require.   Since the company and its management are  in
possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

In the event you request acceleration of the effective date of the pending regist ration
statement , please provide  a written statement from the company acknowledging that:

 should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commission from taking any action with respect
to the filing;

 the action of the Commission or the staff, acting pursuant t o delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in the filing; and

 the company may not assert staff comments and the declaration of effect iveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.

Please refer to Rules 460 and 461 regarding requests for  acceleration .  We will consider a
written request for acceler ation of the effective date of the registration statement as confirmation

Joshua Kornberg
Skyline Medical Inc.
March 30, 2016
Page 2

 of the fact that those requesting acceleration are aware of their respective responsibilities under
the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the registered securities .

Please  contact Brian Soares at (202) 551 -3580  with any questions.

Sincerely,

/s/ Brian Soares for

Amanda Ravitz
Assistant Director
Office of Electronics and Machinery

cc: Martin Rosenbaum , Esq.
Maslon LLP

CORRESP
1
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Skyline Medical Inc.

2915 Commers Drive, Suite 900

Eagan, Minnesota 55121

February 10, 2016

BY EDGAR

United States Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

Attention: Mr. Caleb French

Re:  Skyline Medical
                                         Inc.

                                         Registration Statement on Form S-4

                                         File No. 333-209092

                                         Request for Acceleration

Ladies and Gentlemen:

In accordance with Rule 461 of the General Rules and Regulations
under the Securities Act of 1933, as amended, Skyline Medical Inc., a Delaware corporation (the “Registrant”),
hereby requests that the effectiveness of the above-referenced Registration Statement on Form S-4 (the “Registration Statement”),
be accelerated so that it will be declared effective at 9:00 a.m. Eastern time on February 12, 2016, or as soon thereafter as practicable.

The Registrant hereby acknowledges that:

(i)
should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated
authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect
to the Registration Statement;

(ii)
the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement
effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the
Registration Statement; and

(iii)
the Registrant may not assert staff comments and the declaration of the effectiveness as a defense in any proceeding initiated
by the Commission or any person under the federal securities laws of the United States.

[Signature page follows]

    Very truly yours,

    Skyline Medical Inc.

    By:
    /s/ Joshua Kornberg

    Name: Joshua Kornberg

    Title: Chief Executive Officer

[Signature Page to Acceleration Request]

CORRESP
1
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February 4, 2016

VIA EDGAR

Mr. Nicholas Panos

Special Senior Counsel

Office of Mergers and Acquisitions

Securities and Exchange Commission

100 F Street NE

Washington, D.C. 20549

    Re:
    Skyline Medical Inc.

    Schedule TO

    File No. 5-86172

    Filed: January 22, 2016

Dear Mr. Panos:

This letter responds on behalf of Skyline
Medical Inc. (the “Company”) to your comment letter addressed to Joshua Kornberg dated February 2, 2016 with respect
to the filing listed above. Included below is each of your comments and the corresponding responses supplied by the Company:

Exhibit 99(a)(1)(A)

Summary

 1. The disclosure at page 11 indicates that “[t]here are material
differences between the terms of the Existing Units and the terms of the New Units…” Please provide us with a brief
legal analysis that explains the basis upon which the issuer concluded that Rule 13e-3 was inapplicable to this tender offer transaction.

This tender
offer transaction does not enhance our ability or otherwise enable us to delist and deregister the Existing Units, and therefore
our view is that Rule 13e-3 is inapplicable to the Exchange Offer. As disclosed in the prospectus that forms a part of the related
registration statement on Form S-4 (File No. 333-209092) (the “Form S-4”) at page
32 under “Price Range of Common Stock – Holders,” there are currently 21 holders of record of the Existing Units.
This is less than the minimum number of Existing Unit holders required to deregister the Existing Units under Section 12 of the
Securities Exchange Act of 1934, as amended. Additionally, the Existing Units will separate into their components automatically
on February 29, 2016 (which is only seven days after the expiration date of the Exchange Offer) or earlier in certain circumstances.
These factors provide the Company with the ability to delist or deregister the Existing Units irrespective of the Exchange Offer
and were disclosed to security holders in the prospectus that forms a part of the Form S-4 at page 8 under “Questions and
Answers about the Exchange Offer — Does the Exchange Offer impact the ability of the Company to delist the Existing
Units?” This prospectus was distributed to security holders together with the Offer Letter.

Withdrawal rights, page 21

 2. The disclosure indicates that “[a]n extension of the Expiration
Date will not affect a holder of Existing Unit’s withdrawal rights, unless otherwise provided or as required by applicable
law.” Advise us of the circumstances under which an existing unit holder’s rights could be affected should an extension
of the expiration date occur, or delete the disclosure. Refer to Rule 13e-4(f)(2)(i).

Before requesting effectiveness of the
Form S-4, the Company undertakes to file an amendment to Schedule TO, which will include an amended copy of Exhibit 99(a)(1)(A)
that replaces the phrase on page 22, “[a]n extension of the Expiration Date will not affect a holder of Existing Unit’s
withdrawal rights, unless otherwise provided or as required by applicable law,” with the following phrase “[a]n extension
of the Expiration Date will not affect a holder of Existing Unit’s withdrawal rights.” The Company also undertakes
to file an amendment to the Form S-4 to revise the corresponding language on page 94 of the prospectus contained therein.

Financial Information Regarding the
Company, page 28

 3. The disclosure indicates that financial information has been incorporated
by reference from the issuer’s Form 10-K and Form 10-Q. The Division of Corporation Finance takes the view that financial
information incorporated by reference in order to satisfy Items 1010(a) and (b) of Regulation M-A must be summarized and disclosed
in accordance with Item 1010(c) of Regulation M-A. Refer to Instruction 6 to Item 10 of Schedule TO and corresponding interpretation
I.H.7 in the July 2001 Supplement to the Manual of Publicly Available Telephone Interpretations: http://www.sec.gov/interps/telephone/phonesupplement3.htm
Please advise us whether or not the financial information included at pages F-3-F-27 in the related Form S-4 filing has been distributed
to security holders, or revise the Offer Letter to include the Item 1010(c) information and disseminate it in accordance with Rule
13e-4(e)(3).

The staff is advised that the entire prospectus
that forms a part of the Form S-4, and, therefore, pages F-3-F-27 thereof, has been distributed to security holders together with
the Offer Letter.

* * *

In addition, we acknowledge that:

 · we are responsible for the adequacy and accuracy of the disclosures in the filing;

 · staff comments or changes to disclosures in response to staff comments do not foreclose the Commission
from taking any action with respect to the filing; and

 · we may not assert staff comments as a defense in any proceeding initiated by the Commission or
any person under the federal securities laws of the United States.

Thank you for your consideration. As the
Company would like to have the Form S-4 declared effective prior to February 16, 2016, your prompt attention to the foregoing would
be greatly appreciated. If you have any other questions or further comments about these responses, please contact the undersigned
at (651) 389-4806 or Martin Rosenbaum, Esq. at (612) 672-8326.

Sincerely,

/s/ Bob Myers

Bob Myers

Chief Financial Officer

cc:  Joshua Kornberg, President, Chief Executive Officer and Interim Chairman of the Board

    Martin R. Rosenbaum,
Esq., Maslon LLP

    Spencer G. Feldman,
Esq., Olshan Frome Wolosky LLP

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

DIVISION OF
CORPORATION FINANCE
February 2 , 2016
Via Email
Joshua Kornberg
Chief Executive Officer, President and Interim Chairman of the Board
Skyline Medical Inc.
2915 Commers Drive, Suite 900
Eagan, Minnesota 55121

Re:  Skyline Medical Inc.
Schedule TO
File No. 5 -86172
Filed :  January 22 , 2016

Dear Mr. Kornberg :

We have reviewed the above -captioned  filing , and have the following comments .  In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.  To the extent you believe our comments do not apply to your facts
and circumstanc es or believe an amendment is inappropriate , please tell us why in your response.

After reviewing any amendment to your registration statement and any information you
provide in response to these comments,  we may raise additional comments.

Exhibit 99(a)(1)(A)

Summary

1. The disclosure at page 11 indicates that “[t]here are material differences between the terms of
the Existing Units and the terms of the New Units …”  Please provide us with a brief legal
analysis that explains the basis upon which the issuer concluded that Rule 13e -3 was
inapplicable to this tender offer transaction.

Withdrawal rights, page 21

2. The disclosure indicates that “[a]n extension of the Expiration Date will not affect a holder of
Existing Unit’s withdrawal rights, unless otherwise provided or as required by applicable
law.”  Advise us of the circumstances under which an existing unit holder ’s rights could be
affected should an extension of the expiration date occur, or delete the disc losure.  Refer to
Rule 13e -4(f)(2)(i).

Joshua Kornberg
Skyline Medical Inc.
February 2, 2016
Page 2

 Financial Information Regarding the Company, page 28

3. The disclosure indicates that financial informa tion has been incorporated by reference from
the issuer ’s Form 10 -K and Form 10 -Q.  The Division of Corporation Finance takes the view
that financial information incorporated by  reference in order to satisfy Items 1010(a) and (b)
of Regulation M -A must be summarized and disclosed in accordance with Item 1010(c) of
Regulation M -A.  Refer to Instruction 6 to Item 10 of Schedule TO and corresponding
interpretation I.H.7 in the July 2001 Supplement  to the Manual  of Publicly Available
Telephone Interpretation s: http://www.sec.gov/interps/telephone/phonesupplement3.htm
Please advise us whether or not the financial information included at pages F -3-F-27 in the
related Form S -4 filing has been d istributed to sec urity holders, or revise the  Offer Letter to
include th e Item 1010(c)  information and disseminate it in accordance with Rule 13e -4(e)(3).
* * * * *

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes all information require d under the Securities
Exchange Act of 193 4 and all applicable Exchange  Act rules require.  Since the company and its
management are in possession of all facts relating to a company’s disclosure, they are
responsible for the accuracy and adequacy of the disclosures made.

 Please refer  to Rules 460 and 461 regarding request s for acceleration  with respect to the
related Form S -4 filing .  We will consider a written request for acceleration of the effective date
of the registration statement as confirmation of the fact that those requesting accelerati on are
aware of their respective responsibilities under the Securities Act of 1933 and the Securities
Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in
the above registration statement.  Please allow adequat e time after the filing of any amendment
for further review before submitting a request for acceleration.

Please provide a written statement from the company  acknowledging that:

 the Com pany  is responsible for the adequacy and accuracy of the disclosure in the filing;

 staff comments or changes  to disclosure in response to staff comments do not f oreclose the
Commission from taking action with respect to the filing ; and

 the company may not assert staff comments as a defense in any proceeding initiated by the
Commission or any person under the federal securities laws of the United States.

  You may contact me at (202) 551 -3266 with any questions  regarding  and of the
comments issued on the Schedule TO, and Caleb French at (202) 551 -6947 with respect to any
questions relating to taking the Form S -4 effective .

Joshua Kornberg
Skyline Medical Inc.
February 2, 2016
Page 3

 Sincerely ,

/s/ Nicholas P. Panos

Nicholas P. Panos
Senior Special Counsel
Office of Mergers and Acquisitions

cc:  Martin R. Rosenbaum, Esq.
Spencer G. Feldman, Esq.

Mail Stop 3030
January 29, 2016

Via E -mail
Joshua Kornberg
President, Chief Executive Officer and Interim Chairman of the Board
Skyline Medical Inc.
2915 Commers Drive, Suite 900
Eagan, Minnesota 55121

Re: Skyline Medical Inc.
  Registration Statement on Form S-4
Filed  January 22, 2016
  File No.  333-209092

Dear Mr. Kornberg :

This is to advise you that we have not  reviewed and will not review your registration
statement .

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 193 3 and
all applicable Securities  Act rules require.   Since the company and its management are  in
possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

In the event you request acceleration of the effective date of the pending regist ration
statement , please provide  a written statement from the company acknowledging that:

 should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commission from taking any action wit h respect
to the filing;

 the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in th e filing; and

 the company may not assert staff comments and the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.

Joshua Kornberg
Skyline Medical Inc.
January 29, 2016
Page 2

 Please refer to Rules 460 and 4 61 regarding requests for  acceleration .  We will consider a
written request for acceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of their respective responsibilities under
the Securities Act of 1933 and th e Securities Exchange Act of 1934 as they relate to the proposed
public offering of the registered securities .

Please  contact Caleb French  at (202) 551 -6947  with any questions.

Sincerely,

 /s/ Caleb French for

 Amanda Ravitz
Assistant Director
Office of Electronics and Machinery

cc:  Martin R. Rosenbaum, Esq.

Mail Stop 3030

December 14, 2015

Via E -mail
Mr. Joshua Kornberg
President, Chief Executive Officer and Director
Skyline Medical , Inc.
2915 Commers Drive, Suite 900
Eagan, Minnesota 55121

Re: Skyline Medical, Inc.
 Form 10-K for the Fiscal Year Ended December 31, 2014
Filed April 30, 2015
  File No. 001-36790

Dear  Mr. Kornberg :

We have completed our review of your filings.  We remind you that our comments or
changes to disclosure in response to our comments do not foreclose the Commission from taking
any action with respect to the company or the filing s and the company may not assert staff
comments as a defense in any proceeding initiated by the Commission or any person under the
federal securities laws of the United States.  We urge all persons who are responsible for the
accuracy and adequacy of the disclosure in the filing s to be certain that the filing s include the
information the Securities Exchange Act of 1934 and a ll applicable rules require.

Sincerely,

 /s/ Kevin Kuhar

Kevin Kuhar
Accounting Branch Chief
Office of Electronics and Machinery

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[SKYLINE MEDICAL INC. LETTERHEAD]

December 9, 2015

VIA EDGAR AND FEDERAL EXPRESS

Mr. Kevin Kuhar

Accounting Branch Chief

Office of Electronics and Machinery

Securities and Exchange Commission

100 F Street NE

Washington, D.C. 20549

Re:  Skyline Medical Inc.

    Form
10-K for the Fiscal Year Ended December 31, 2014

    Filed April 30, 2015

    Form 10-Q for the Quarterly Period
                                         Ended September 30, 2015

    Filed November 13, 2015

    File No. 001-36790

Dear Mr. Kuhar:

This letter responds on behalf of Skyline
Medical Inc. (the “Company”) to your comment letter addressed to Joshua Kornberg dated December 2, 2015 with respect
to the filing listed above. Included below is your comment and the corresponding response supplied by the Company:

Form 10-Q for the Quarterly Period
Ended September 30, 2015

Exhibit 32.1

 1. We note that your certifications refer to the Form 10-Q for the
quarter ended June 30, 2015. Please file an amendment to your Form 10-Q for the period ended September 30, 2015 that includes the
entire filing, including Exhibit 31 certifications, together with corrected Exhibit 32 certifications that refer to the proper
period.

The Company will file a Form 10-Q/A to provide
an updated Exhibit 32 certification that refers to the quarter ended September 30, 2015, that is currently dated and refers to
the Form 10-Q/A. The Exhibit 32 certification in the originally filed Form 10-Q for the quarter ended September 30, 2015 erroneously
referred to the quarter ended June 30, 2015, when it should have referred to the quarter ended September 30, 2015.

In addition, we acknowledge that:

 · we are responsible for the adequacy and accuracy of the disclosures in the filing;

 · staff comments or changes to disclosures in response to staff comments do not foreclose the Commission
from taking any action with respect to the filing; and

    1

Mr. Kevin Kuhar

December 9, 2015

Page 2

 · we may not assert staff comments as a defense in any proceeding initiated by the Commission or
any person under the federal securities laws of the United States.

Thank you for your consideration. If you
have any other questions or further comments about these responses, please contact the undersigned at (651) 389-4806.

Sincerely,

Bob Myers

Chief Financial Officer

cc:  Martin Rosenbaum, Maslon LLP

    Brett Olsen, Olsen
Thielen & Co., Ltd.

Mail Stop 3030
December 2 , 2015

Via E -mail
Mr. Joshua Kornberg
President, Chief Executive Officer and Director
Skyline Medical  Inc.
2915 Commers Drive, Suite 900
Eagan, Minnesota 55121

Re: Skyline Medical  Inc.
 Form 10-K for the Fiscal Year Ended  December 31, 2014
Filed April 30, 2015
  Form 10-Q for the Quarterly Period Ended  September 30, 2015
Filed  November 13, 2015
  File No. 001-36790

Dear  Mr. Kornberg :

We have limited our review  of your filing  to the financial statements and related
disclosures and have the following comment.  In some of our comments, we may ask you to
provide us with information so we may better understand your disclosure.

Please respond to this comment  within ten busine ss days by providing the requested
information or advis e us as soon as possible when you will respond.  If you do not believe our
comment appl ies to your facts and circumstances, please tell us why in your response.

After revie wing your response to this comment, we may have  additional comments.

Form 10 -Q for the Quarterly Period Ended September 30, 2015

Exhibit 32.1

1. We note that your certifications refer to the Form 10 -Q for the quarter ended June 30,
2015.   Please file an amendment to your Form 10 -Q for the period ended September 30,
2015 that includes the entire filing, including Exhibit 31 certifications, together with
corrected Exhibit 32 certifications that refer to the proper period .

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Exchange Act of
1934 and all applicable Exchange Act rules require.   Since the compa ny and its management are

Mr. Joshua Kornberg
Skyline Medical  Inc.
December 2, 2015
Page 2

 in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

 In responding to our comment, please provide  a written statement from the com pany
acknowledging that:

 the company is responsible for the adequacy and accuracy of the disclosure in the filing;

 staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect t o the filing; and

 the company may not assert staff comments as a defense in any proceeding initiated by
the Commission or any person under the federal securities laws of the United States.

You may contact Gary Newberry at (202) 551 -3761 or Lynn Dicker, S enior Accountant, at
(202) 551 -3616 with any questions .  You may also reach  me at ( 202) 551 -3662 .

Sincerely,

 /s/ Lynn Dicker for

            Kevin Kuhar
            Accounting Branch Chief
Office of Electronics and Machinery

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    d818150corresp.htm

August 24, 2015

VIA EDGAR

Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, D.C. 20549

Attention: Mr. Jay Mumford

Re:

Skyline Medical Inc.

Registration Statement on Form S-1

File No. 333-198962

Dear Mr. Mumford:

Pursuant to Rule 461 under the Securities Act of 1933, as amended, the undersigned, as underwriter of the proposed offering, hereby joins the request of Skyline Medical Inc. that the effective date of the above-referenced Registration Statement on Form S-1 be declared effective at 4:30 p.m. (Washington, D.C. time) on Tuesday, August 25, 2015, or as soon as practicable thereafter.

In connection with the proposed offering of the Company’s securities, copies of the preliminary prospectuses dated August 10, 2015 were distributed to the following persons in the following approximate amounts:

To Whom Distributed

Number of Copies

Institutions

16

Syndicate

6

Individuals

868

Total

890

We have complied and will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.

Sincerely,

Dawson James Securities, Inc.

By:

/s/ Robert D. Keyser, Jr.

Name

Robert D. Keyser, Jr.

Title

Chief Executive Officer

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    n814150corresp.htm

Skyline Medical Inc.

2915 Commers Drive, Suite 900

Eagan, Minnesota 55121

August 24, 2015

BY EDGAR

United States Securities and  Exchange Commission

100 F Street, NE

Washington, D.C. 20549

Attention: Mr. Jay Mumford

Re:

Skyline Medical Inc.

Registration Statement on Form S-1

File No. 333-198962

Request for Acceleration

Ladies and Gentlemen:

In accordance with Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Skyline Medical Inc., a Delaware corporation (the “Registrant”), hereby requests that the effectiveness of the above-referenced Registration Statement on Form S-1, as amended (the “Registration Statement”), be accelerated so that it will be declared effective at 4:30 p.m. Eastern time on August 25, 2015, or as soon thereafter as practicable.

The Registrant hereby acknowledges that:

(i)             should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration Statement;

(ii)            the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement; and

(iii)           the Registrant may not assert staff comments and the declaration of the effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.

It is the Registrant’s understanding that its registration of the units and common stock of the Registrant under the Securities Exchange Act of 1934 on Form 8-A (File No. 001-36790) shall automatically become effective upon the later of the Commission’s receipt of certification from the NASDAQ Capital Market with respect to the units and common stock of the Registrant and the effectiveness of the Registration Statement.

[Signature page follows]

Very truly yours,

Skyline Medical Inc.

By:

/s/ Joshua Kornberg

Name: Joshua Kornberg

Title:   Chief Executive Officer

[Signature Page to Acceleration Request]

October 6 , 2014

Via E -Mail
Joshua Kornberg
Chief Executive Officer
Skyline Medical Inc.
2915 Commers Drive, Suite 900
Eagan, Minnesota 55121

Re:   Skyline Medical Inc.
         Registration Statement on Form S -1
         Filed September  26, 2014
         File No. 333 -198962

Dear Mr. Kornberg :

This is to advise you that we have not reviewed and will not review your registration
statement .

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 193 3 and
all applicable Securities  Act rules require.   Since the company and its management are  in
possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

In the event you request acceleration of the effective date of the pending regist ration
statement please provide  a written statement from the company acknowledging that:

 should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commission from taking any action with  respect
to the filing;

 the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in the  filing; and

 the company may not assert staff comments and the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.

Please refer to Rules 460 and 46 1 regarding requests for  acceleration .  We will consider a
written request for acceleration of the effective date of the registration statement as confirmation

Joshua Kornberg
Skyline Medical Inc.
October 6 , 2014
Page 2

 of the fact that those requesting acceleration are aware of their respective responsibilities un der
the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the registered securities .

You may contact Jay Mumford at 202 -551-3637  with any questions.

Sincerely,

 /s/ Jay Mumford for

 Amanda Ravitz
Assistant Director

cc: (via e -mail)   Martin Rosenbaum, Esq.
Maslon Edelman Borman & Brand, LLP

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BioDrain
Medical, Inc.

2915 Commers Drive, Suite 900

Eagan, MN 55121

May 13, 2013

Transmitted via EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Washington, DC 20549

Attention: Russell Mancuso

 Re: BioDrain Medical, Inc. (the “Company”)

Registration Statement on Form
S-1

Amendment No. 5 Filed May 10,
2013

File
No. 333-179145

Dear Mr. Mancuso:

The undersigned respectfully requests that
the Registration Statement on Form S-1 of BioDrain Medical, Inc. (SEC File No. 333-179145) be declared effective at 9:00 a.m.,
Washington, D.C. time, on Tuesday, May 14, 2013, or as soon thereafter as is practicable.

In connection with this request, the Company
hereby acknowledges that:

 · should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, such declaration
does not foreclose the Commission from taking any action with respect to the filing;

 · the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does
not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and

 · the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by
the Commission or any other person under the federal securities laws of the United States.

    Sincerely,

    BIODRAIN MEDICAL, INC.

    By:
    /s/ Bob Myers

    Bob Myers, Chief Financial Officer

CORRESP
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[BIODRAIN MEDICAL, INC. LETTERHEAD]

April 24, 2013

VIA EDGAR AND FEDERAL EXPRESS

Mr. Russell Mancuso

Branch Chief

Securities and Exchange Commission

100 F Street NE

Washington, D.C. 20549

    Re:
    BioDrain Medical, Inc. (the “Company”)

    Amendment No. 4 to Registration Statement on Form S-1

    File No. 333-179145

Dear Mr. Mancuso:

Filed herewith is Amendment No. 4 to the
registration statement referred to above. A redlined copy, marked to show changes from Amendment No. 3, is enclosed.

Amendment No. 4 contains updated disclosures,
including financial information for the year ended December 31, 2012. Further, Amendment No. 4 responds to certain comments raised
by the staff in your comment letter addressed to Joshua Kornberg dated February 21, 2013 with respect to Amendment No. 3. We responded
to certain of those comments in my letter dated March 27, 2013, and we acknowledge the staff’s letter, dated April 11, 2013,
with two further comments in response to my letter as discussed below.

Comment 1 in the April 11, 2013 letter
stated:

We are unable to provide you with
comfort regarding the completeness or accuracy of your analyses or conclusions that you provided in response to our comments, including
your response to prior comments 3 and 4. If you elect to seek acceleration of the effective date of this registration statement
after you address the other comment in this letter, we remind you of the acknowledgements that you must provide with the acceleration
request as indicated at the end of this letter.

We acknowledge the above statement. The
Company intends to seek acceleration of the effective date of the registration statement after we receive confirmation that we
have addressed the outstanding comments (except that we understand based on the above comment 1 that the staff will not provide
additional comfort with respect to prior comments 3 and 4). When the Company seeks acceleration, the required acknowledgements
will be included with the request.

Comment 2 in the April 11, 2013 letter
stated:

We will continue to evaluate your
responses to prior comments 1-2 and 5 when you amend your registration statement.

Mr. Russell Mancuso

April 24, 2013

Page 2

Included below are your prior comments
1, 2 and 5 from the February 21, 2013 comment letter, and the corresponding response supplied by the Company:

Prospectus Summary, page 1

 1. Please expand your prospectus summary disclosure regarding your
ability to continue as a going concern to inform investors clearly about the language in your auditor’s report regarding
substantial doubt about your ability to continue as a going concern. Also highlight in your prospectus summary the amount of your
obligations that is past due or in default.

In the Prospectus Summary on page 1 of Amendment
No. 4, the Company has included disclosure under the caption “Financial Results; Ability to Continue as a Going Concern”
that informs investors about the language in the auditor’s report regarding substantial doubt about the Company’s ability
to continue as a going concern. We have also highlighted in that section the amounts that become due in the near future. That section
makes reference to the more detailed section of Management’s Discussion and Analysis of Financial
Condition and Results of Operations” captioned “Liquidity and Capital Resources –
Plan of Financing; Going Concern Qualification” on pages 14 and 15 of Amendment No. 4.

Executive Compensation, page 30

 2. Please update your disclosure required by item 402 of Regulation
S-K to include the information for your most recently completed fiscal year.

In Amendment No. 4, under the caption “Executive
Compensation” on pages 34 through 40, the company has updated the executive compensation information to provide the disclosures
required by Item 402 of Regulation S-K for the fiscal year ended December 31, 2012.

Financial Statements, page F-1

 5. Please update the financial statements as required by Rule 8-08
of Regulation S-X.

In Amendment No. 4, starting on page F-1,
the Company has included financial statements for the years ended December 31, 2012 and 2011, which satisfy the requirements of
Rule 8-08 of Regulation S-X.

* * * * *

Mr. Russell Mancuso

April 24, 2013

Page 3

In addition, we acknowledge that:

 · we are responsible for the adequacy and accuracy of the disclosures in the filing;

 · staff comments or changes to disclosures in response to staff comments do not foreclose the Commission
from taking any action with respect to the filing; and

 · we may not assert staff comments as a defense in any proceeding initiated by the Commission or
any person under the federal securities laws of the United States.

Please confirm that Amendment No. 4 satisfies
the outstanding staff comments as described above. If you have any other questions or further comments about these responses, please
contact the undersigned at (651) 389-4806.

Sincerely,

Bob Myers

Chief Financial Officer

    cc:
    Martin Rosenbaum, Maslon Edelman Borman & Brand LLP

    Brett Olsen, Olsen Thielen & Co., Ltd.

April 11 , 2013

Via E -mail
Joshua Kornberg
Chief Executive Officer
BioDrain Medical, Inc.
2915 Commers Drive, Suite 900
Eagan, Minnesota 55121

Re: BioDrain Medical, Inc.
 Registration Statement on Form S -1
Amendment No. 3 Filed February 8, 2013
Response Dated March 27, 2013
File No. 333 -179145

Dear Mr. Kornberg:

We have reviewed your letter dated March 27, 2013 and have the following comments.
Please respond to this letter by amending your registration statement .  Where you do not believe
our comments apply to your facts and circumstances or do not believe an amendment is
appropriate, please tell us why in your response.

After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additiona l comments.

1. We are unable to provide you with comfort regarding the completeness or accuracy of
your analyses or conclusions that you provided in response to our comments, including
your response to prior comments 3 and 4.  If you elect to seek accelerat ion of the
effective date of this registration statement after you address the other comment  in this
letter, we remind you of the acknowledgements that you must provide with the
acceleration request as indicated at the end of this letter.
2. We will continu e to evaluate your responses to prior comments 1 -2 and 5 when you
amend your registration statement.

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the informa tion the Securities Act of 1933 and
all applicable Securities Act rules require.   Since the company and its management are in
possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

Joshua Kornberg
BioDrain Medical, Inc.
April 11 , 2013
Page 2

 Notwithstanding our comments, in the event you request acceleration of the effective date
of the pending registration statement please provide a written statement from the company
acknowledging that:

 should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commission from taking any action with respect
to the filing;

 the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in the filing; and

 the company may not assert staff comments and the declaration of effectiveness as a
defense in any proceedi ng initiated by the Commission or any person under the federal
securities laws of the United States.

Please refer to Rules 460 and 461 regarding requests for acceleration.  We will consider a
written request for acceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of thei r respective responsibilities under
the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the securities specified in the above registration statement.  Please allow
adequate time for us to rev iew any amendment prior to the requested effective date of the
registration statement.

Please contact Jay Mumford at 202 -551-3637 or me at 202 -551-3617 with any questions.

Sincerely,

 /s/ Russell Mancuso

        Russell Mancuso
        Branch Chief

cc (via e -mail):  Martin Rosenbaum, Esq.

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BioDrain
Medical, Inc.

	2915 Commers Drive,
Suite

	Eagan, Minnesota 55121

	 651.389.4806 phone

	 651.389.4807 fax

	 www.biodrainmedical.com

March 27, 2013

VIA EDGAR AND FEDERAL EXPRESS

Mr. Russell Mancuso

Branch Chief

Securities and Exchange Commission

100 F Street NE

Washington, D.C. 20549

 Re: BioDrain
Medical, Inc.

Registration Statement on Form S-1

Amendment No. 3 Filed February 8,
2013

File No. 333-179145

Dear Mr. Mancuso:

This letter responds on behalf of BioDrain Medical, Inc. (the
“Company”) to your comment letter addressed to Joshua Kornberg dated February 21, 2013 with respect to the filing listed
above. The Company intends to file a further amendment to the registration statement after audited financial statements for the
year ended December 31, 2012 are available. However, the Company respectfully requests that the staff review the responses below
and confirm that such responses adequately respond to your comments.

Included below is each of your comments and the corresponding
response supplied by the Company:

Prospectus Summary, page 1

 1. Please expand your prospectus summary disclosure regarding your ability to continue as a going
concern to inform investors clearly about the language in your auditor’s report regarding substantial doubt about your ability
to continue as a going concern. Also highlight in your prospectus summary the amount of your obligations that is past due or in
default.

The section of Management’s
Discussion and Analysis of Financial Condition and Results of Operations” (MD&A) captioned “Liquidity
and Capital Resources – Plan of Financing; Going Concern Qualification” has been updated on page 34 of the Company’s
Form 10-K, filed on March 22, 2013, to reflect the fact that the Company does not currently have any obligations in default. The
MD&A section in the Form S-1 will be updated to conform to MD&A in the Form 10-K. In the next amendment to the Form S-1,
we intend to include substantially the following disclosure, updated as appropriate, in the Prospectus Summary on page 1 under
the caption “Financial Results; Ability to Continue as a Going Concern”:

“We have approximately $2,834,000 in debts,
liabilities and cash obligations that become due in the first and second quarters of calendar 2013. We may default on significant
debt that becomes due by the second quarter of 2013, including secured notes held by two of the selling stockholders in the aggregate
amount of approximately $597,000, for which the due date has been extended to April 30, 2013. Therefore, we may be unable to continue
in business. The Company has suffered recurring losses from operations and has a stockholders’
deficit. Although we have been able to fund our current working capital requirements, principally through debt and equity
financing, there is no assurance that we will be able to do so in the future. These factors raise substantial
doubt about our ability to continue as a going concern. As a result of the above factors, our independent registered public
accounting firm has indicated in their audit opinion, contained in our financial statements included
in this prospectus, that they have serious doubts about our ability to continue as a going concern. See
‘Management’s Discussion and Analysis of Financial Condition and Results of Operations – Liquidity and Capital
Resources – Plan of Financing; Going Concern Qualification.’”

Executive Compensation, page 30

 2. Please update your disclosure required by item 402 of Regulation S-K to include the information
for your most recently completed fiscal year.

When we file the next amendment, we will update the executive
compensation information to provide the disclosures required by Item 402 of Regulation S-K for the fiscal year ended December 31,
2012.

Selling Security Holders, page 47

 3. Please expand your response to comment 2 in our letter to you dated February 16, 2012 to tell
us clearly whether any of the offered shares represent (1) fees for attending future board meetings, (2) shares underlying any
portion of a note for which you have not yet received the “advance,” or (3) consideration to be earned upon default,
pre-payment or any other event that has not yet occurred.

Appendix A provides detailed information on the shares being
registered on the Form S-1. We confirm as follows: (1) None of the shares being registered represent fees for attending future
board meetings. The board meetings for which Dr. Herschkowitz received shares as indicated in Appendix A were all completed prior
to April 2012. (2) None of the shares being registered are shares underlying any portion of a note for which the company has not
yet received the advance. As indicated in Appendix A, all advances by SOK Partners were completed by May 2012. Some balances represented
prepaid interest; however, all prepaid interest covered by the notes was actually earned in or before April 2012 (in the case of
Dr. Herschkowitz) or August 2012 (in the case of SOK Partners). (3) None of the shares being registered represent consideration
to be earned upon default, pre-payment or any other event that has not yet occurred. As indicated in Appendix A, certain penalty
shares were received by Dr. Herschkowitz for defaults; however, these defaults all occurred prior to August 2012. Dr. Herschkowitz
also received shares on account of certain dilutive issuances; however, such issuances all occurred prior to August 2012.

 4. Refer to your response to comment 4 in our letter dated February 16, 2012. Although you may
not have complied with your obligations in the note and related note agreements, it remains unclear why the selling stockholder
who provides you periodic “advances” should not be identified as an underwriter who is required to sell at a fixed
price for the duration of the offering given that the terms of the agreements he negotiates with you include provisions directing
the proceeds of his investment to your activities regarding promotion of a market for the securities offered by the selling stockholder.
Please advise, citing any relevant authority on which you relied regarding the effect of the provision included in the note agreements.
Include in your response the dates of each “advance” provided to you under the agreements with the selling stockholder
or his affiliates.

Legal Standard. In evaluating whether Dr.
Herschkowitz and his affiliate, SOK Partners, are truly acting as selling stockholders in a secondary offering, we turn to paragraph
612.09 of the staff’s Compliance and Disclosure Interpretations, Securities Act Rules, which reads:

“It is
important to identify whether a purported secondary offering is really a primary offering, i.e., the selling shareholders are actually
underwriters selling on behalf of an issuer. Underwriter status may involve additional disclosure, including an acknowledgment
of the seller’s prospectus delivery requirements. In an offering involving Rule 415 or Form S-3, if the offering is deemed
to be on behalf of the issuer, the Rule and Form in some cases will be unavailable (e.g., because of the Form S-3 “public
float” test for a primary offering, or because Rule 415(a)(1)(i) is available for secondary offerings, but primary offerings
must meet the requirements of one of the other subsections of Rule 415).  The question of whether
an offering styled a secondary one is really on behalf of the issuer is a difficult factual one, not merely a question of who receives
the proceeds. Consideration should be given to how long the selling shareholders have held the shares, the circumstances under
which they received them, their relationship to the issuer, the amount of shares involved, whether the sellers are in the business
of underwriting securities, and finally, whether under all the circumstances it appears that the seller is acting as a conduit
for the issuer.”

Analysis. As the interpretation above states,
this is often a difficult factual question. However, in examining the specific facts surrounding this registration statement and
applying the six-factor test in the above C&DI, we believe the answer is straightforward: Dr. Herschkowitz and SOK Partners
are not acting as underwriters, and this is truly a secondary offering on their behalf. Therefore, the selling stockholders are
entitled to use the shelf registration statement in an at-the-market offering of the shares. Our analysis of the six factors is
as follows:

How long the selling shareholders have held their shares.
Appendix A details, among other things, the dates and amounts of the cash investments by Dr. Herschkowitz and SOK Partners and
the other events that led to issuance of the shares. More than 90% of the shares being registered were issued (as described below)
by August 2012. Note: For purposes of this discussion, we consider shares issuable under a convertible note to have been
“issued” when the investment was made and the note was issued. This is consistent with the treatment of convertible
notes under Rule 144(d)(3)(ii), under which the conversion shares are deemed to have been issued at the time of issuance of the
note.

Thus, of the 95.5 million shares being registered on the Form
S-1:

 · 55.5 million shares (58% of the shares being registered) have been issued for more than 10 months
(11.0 million shares issued by May 2012, plus 44.5 million shares issuable under convertible notes that were issued by May 2012).

 · An additional 34.0 million of the shares were issued by August 2012. In other words, an aggregate
89.5 million of the shares being registered on the Form S-1 (94% of the shares being registered) have been issued for more than
7 months. These shares represent 99% of the shares being registered for Dr. Herschkowitz and SOK Partners.

 · The remaining 6.0 million shares (6% of the shares being registered) have been issued since August
2012 – 0.8 million shares, plus 5.0 million shares issuable pursuant to convertible notes and 0.2 million shares issuable
pursuant to warrants. This amount includes 0.8 million shares issued to Dr. Herschkowitz, representing 1% of the aggregate amount
being registered for him and SOK Partners.

The staff’s comment appears to be concerned principally
with Dr. Herschkowitz and SOK Partners. Because 99% of their shares have been issued for more than six months, and a majority of
such shares for over 10 months, these facts are persuasive evidence that these holders are not acting as underwriters.

The circumstances under which the selling shareholders received
the shares. Dr. Herschkowitz and SOK Partners received the shares in connection with long-term private financing transactions
in which they were acting as private equity investors. In December 2011 when Dr. Herschkowitz made his first $225,000 investment,
BioDrain was close to bankruptcy. This was an extremely risky investment, and Dr. Herschkowitz and his affiliates had no prior
relationship with BioDrain.

By March 2012, BioDrain had once again run out of funds. Dr.
Herschkowitz was once again willing to provide the necessary financing – another $15,000 individually, and up to $600,000
through SOK Partners, an investment partnership managed by him and Mr. Kornberg.

On March 28, 2012, BioDrain signed an amended and restated note
purchase agreement with Dr. Herschkowitz and signed a convertible note purchase agreement with SOK Partners for its new SOK investment
up to a total principal amount of $600,000. SOK eventually made cash advances in March, April and May 2012 totaling $357,282.

BioDrain continued to experience severe financial difficulty.
On April 20, 2012, Dr. Herschkowitz sent a letter advising the Company of the occurrence of numerous events of default under the
terms of his note and note purchase agreement and asserting significant rights under his security interest in substantially all
assets of the Company. He deferred any enforcement of his rights as a secured creditor, pending the negotiation of a comprehensive
settlement agreement.

On April 23, 2012, the previous CEO resigned and the Board of
Directors appointed Mr. Kornberg as CEO. Over the next several months, the company, led by Mr. Kornberg, worked to restructure
much of its other debt. After May 2012, the company did not receive further advances from SOK Partners but instead commenced a
separate private offering of common stock and warrants.

After continued negotiations between Dr. Herschkowitz and the
independent directors of BioDrain, on August 13, 2012 BioDrain entered into a forbearance agreement with Dr. Herschkowitz and SOK
Partners, under which BioDrain, among other things, (i) confirmed Dr. Herschkowitz’s entitlement to the 7.5 million penalty
shares issuable to him upon the default, and (ii) issued an aggregate 26.5 million shares to Dr. Herschkowitz and SOK Partners
in recognition of their antidilution rights under a March 14, 2012 letter agreement.

In summary, the shares being registered have been issued in
connection with very risky investments or in consideration of contractual rights upon default or to compensate the investors for
dilution. These investments allowed BioDrain to continue its turnaround and stay in business. The investment agreements contained
typical provisions confirming that the investors were purchasing for investment and without a view to any distribution in violation
of the federal securities laws.

The relationship of the selling shareholders to the issuer.
Again, as described in detail in the preceding section, Dr. Herschkowitz and SOK Partners received the shares in connection with
long-term private financing transactions in which they were acting strictly as private equity investors for their own account.
Until April 2012, the original investment arrangements were negotiated with BioDrain’s management. After Mr. Kornberg became
CEO, the investors negotiated their contractual arrangements and remedies with the independent directors of BioDrain, and the fundamental
relationship did not change. The parties negotiated their rights and responsibilities relating to a high-risk investment that had
been made by the shareholders, which allowed BioDrain to continue its turnaround and stay in business.

The amount of shares involved.
The shares covered by the Form S-1 represent a majority of BioDrain’s public float. We recognize that the staff has historically
questioned the status of a PIPE offering as a secondary offering if the offering size exceeds a “rule of thumb” test
of one-third of the public float. However, we also understand that the staff developed the six factor test under paragraph 612.09
to analyze the true nature of the offering in a systematic way. In BioDrain’s case, a predominance of the other factors dictate
in favor of confirming that this is a secondary offering. Therefore, the shares should be considered “offered or sold
solely by or on behalf of a person or persons other than the registrant, a subsidiary of the registrant or a person of which the
registrant is a subsidiary”, within the meaning of Rule 415(a)(1)(ii). The offering is not “by or on behalf of the
registrant”, and therefore Rule 415(a)(4), which would require that Form S-3 be available for the offering, is not applicable.

Whether the sellers are in the business of underwriting securities.
Dr. Herschkowitz and SOK Partners are not broker-dealers and are not otherwise in the business of underwriting securities. Instead,
they are classic private equity investors, purchasing large stakes in companies and hoping to realize long-term gains. They have
not acted as underwriters, do not hold themselves out as underwriters and have not regularly participated in public distributions.

Further, the selling shareholders do not regularly take large
positions in public companies. A search of the filings of Dr. Herschkowitz, SOK Partners and Mr. Kornberg with the Commission (Schedules
13D or 13G or Forms 3 or 4) reveals only filings that relate to B

February 21, 2013

Via E -mail
Joshua Kornberg
Chief Executive Officer
BioDrain Medical, Inc.
2915 Commers Drive, Suite 900
Eagan, Minnesota 55121

Re: BioDrain Medical, Inc.
 Registration Statement on Form S -1
Amendment No. 3 Filed February 8, 2013
File No. 333 -179145

Dear Mr. Kornberg:

We have limited our review of your registration statement to those issues we have
addressed in our comments.  In some of our comments, we may ask you to provide us with
information so we may better understand your disclosure.

Please respond to this letter by amending your registration statement and providing the
requested information.   Where you do not believe our comments apply to your fac ts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.

After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional c omments.

Prospectus Summary, page 1

1. Please expand your prospectus summary disclosure regarding your ability to continue as
a going concern to inform investors clearly about the language in your auditor’s report
regarding substantial doubt about your ability to continue as a going concern.  Also
highlight  in your prospectus  summary  the amount of your obligations that is past due or
in default.

Executive Compensation, page 30

2. Please update your disclosure required by Item 402 of Regulation S -K to include the
information for your most recently co mpleted fiscal year.

Joshua Kornberg
BioDrain Medical, Inc.
February 21 , 2013
Page 2

 Selling Security Holders, page 47

3. Please expand your response to comment 2 in our letter to you dated February 16, 2012
to tell us clearly whether any of the offered shares represent (1) fees for  attending  future
board meetings, (2) shares underlying any portion of a note for which you have not yet
received the “advance,” or (3) consideration to be earned upon default, pre -payment or
any other event that has not yet occurred.

4. Refer to your response to comment 4 in our letter dated February 16, 2012.  Although
you may not have complied with your obligations in the note and restated note
agreements, it remains unclear why the selling stockholder  who provides you periodic
“advances”  should not be identified as an underwriter who is required to sell at a fixed
price for the duration of the offering given that the terms of the agreements he negotiates
with you include provisions directing the proceeds of his investment to your activities
regarding promotion of a market for the securities offered by the selling st ockholder.
Please advise, citing any relevant authority on which you relied regarding the effect of
the provision included in the note agreements. Include in your response the dates of each
“advance” provided to you under the agreements with the selling stockholder  or his
affiliates .

Financial Statements , page F -1

5. Please update the financial  statements as required by  Rule 8 -08 of Regulation S -X.

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain tha t the filing includes the information the Securities Act of 1933 and
all applicable Securities Act rules require.   Since the company and its management are in
possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

Notwithstanding our comments, in the event you request acceleration of the effective date
of the pending registration statement please provide a written statement from the company
acknowledging that:

 should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commission from taking any action with respect
to the filing;

 the action of the Commission or the staff, acting pursuant to d elegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in the filing; and

Joshua Kornberg
BioDrain Medical, Inc.
February 21 , 2013
Page 3

  the company may not assert staff comments and the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.

Please refer to Rules 460 and 461 regarding reques ts for acceleration.  We will consider a
written request for acceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of their respective responsibilities under
the Securities  Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the securities specified in the above registration statement.  Please allow
adequate time for us to review any amendment prior to the requested effective  date of the
registration statement.

Please contact Jay Mumford at 202 -551-3637 or me at 202 -551-3617 with any questions.

Sincerely,

 /s/ Russell Mancuso

        Russell Mancuso
        Branch Chief

cc (via e -mail): Martin Rosenbaum, Esq.

CORRESP
1
filename1.htm

BioDrain
Medical, Inc.

	2915 Commers Drive,
Suite

	Eagan, Minnesota 55121

	 651.389.4806 phone

	 651.389.4807 fax

	 www.biodrainmedical.com

February 4, 2013

VIA EDGAR AND FEDERAL EXPRESS

Mr. Russell Mancuso

Branch Chief

Securities and Exchange Commission

100 F Street NE

Washington, D.C. 20549

 Re: BioDrain
Medical, Inc.

Registration Statement on Form S-1

    Amendment No. 2 Filed November 5, 2012

    File No. 333-179145

Dear Mr. Mancuso:

This letter responds on behalf of BioDrain
Medical, Inc. (the “Company”) to your comment letter addressed to Joshua Kornberg dated November 20, 2012 with respect
to the filing listed above. Included below are your comments and the corresponding responses of the Company:

 1. Please respond to our comments 1 through 4 from our letter dated February 16, 2012. [Note: We
have repeated comments 1 through 4 from that previous comment letter as comments 1.1 through 1.4 below.]

Prospectus Summary, page 1

 1.1 Please disclose prominently in your prospectus summary the substantial doubt about your ability
to continue as a going concern as mentioned in the notes to your financial statements.

Under “Prospectus Summary –
Risks Affecting Our Business” on page 1 of the prospectus, we have added a disclosure about the going concern qualification
expressed by our auditors. [Note: This must be added.]

Selling Security Holders, page 32

 1.2 Generally it is inconsistent with Section 5 of the Securities Act to register securities for
resale before the completion of the unregistered issuance of those securities. In this regard, it appears that you have not received
the consideration for the securities that represent payment for attendance at future board meetings. Also, it appears that the
conditions that would cause the issuance of the “Additional Bonus” and that would give the investor the ability to
enforce rights to the pledged shares have not occurred. Please remove these shares from the registration statement or provide us
a complete analysis demonstrating that it is appropriate to register the shares for resale at this time. The analysis that you
provide in response to this comment should cite with specificity and analyze the relevant authority and guidance.

This comment, expressed in February 2012,
is no longer applicable. As described on the cover page of Amendment No. 3, consistent with Rule 415(a)(1), all of the shares being
registered now consist of (i) outstanding shares held by the selling shareholders, (ii) shares issuable upon conversion of outstanding
debt securities or (iii) shares issuable upon conversion of outstanding warrants.

 1.3 We note the statement in your Form 8-K filed December 27, 2011 that you issued 1,500,000 shares
on December 22, 2011. Please tell us why the difference between the number of outstanding shares on November 1, 2011 as reported
on the facing page of your most recent Form 10-Q and January 24, 2012 as disclosed on page 51 of this S-1 is significantly less
than 1,500,000 shares.

The incorrectly stated number of outstanding
shares was an error on my part. I inadvertently used the prior CFO’s spreadsheet that had an aggregate 28,216,986 shares
outstanding. Had I reviewed the final September 30, 2011 10-Q stating the outstanding shares on November 1, 2011; I would have
noticed that there were shares issued subsequent to the end of September that were not included on the spreadsheet. The correct
total of outstanding shares as of November 1, 2011 was 30,427,328 shares. The appropriate number of Outstanding shares per the
S-1 filed on January 24, 2012 is 32,073,995 shares including the 1,500,000 shares issued on December 22, 2011.

 1.4 From Section 4.03 of exhibit 10.29, we note that the selling stockholder participated in designating
the individual who will oversee your program that uses a portion of the proceeds from the selling stockholder to promote the market
for your securities, including the securities offered by the selling stockholder. Please provide us a detailed analysis supporting
your conclusions regarding whether the selling stockholder is an underwriter of the offering registered on this Form S-1. If the
selling stockholder is an underwriter and you are not eligible to use Form S-3, please disclose on the prospectus cover and in
your “Plan of Distribution” the fixed price at which the securities will be sold throughout the duration of the offering.

The staff’s comment relates to the
shares issued to Dr. Samuel Herschkowitz pursuant to the Note Purchase Agreement with Dr. Herschkowitz dated December 20, 2011
included as Exhibit 10.29 (amended and restated agreement executed on March 28, 2012 and included as Exhibit 10.30). The company
believes that the offering by Dr. Herschkowitz of these shares on this Form S-1 should properly be regarded as a secondary offering,
not a primary offering for the reasons set forth below, and that Dr. Herschkowitz is not, nor should he be deemed to be, a statutory
underwriter selling on behalf of the company in respect of such offering.

Dr. Herschkowitz has never been an officer
or director of the company, and he did not ever control the promotion of the market for the company’s common stock. Section
4.03 of the Note Purchase Agreement. Section 4.03 was never observed by the parties; in fact, the $20,000 in proceeds was never
used for the promotional materials described in that section, and the company did not comply with the budget process described
in Section 4.03. In other words, despite the language of this provision, Dr. Herschkowitz did not oversee a program that
used a portion of the proceeds from the selling stockholder to promote the company’s securities, including Dr. Herschkowitz’s
shares that are intended to be offered pursuant to this Form S-1.

More generally, Dr. Herschkowitz was not
an underwriter under the analysis set forth in the Compliance and Disclosure Interpretations, Securities Act Rules, paragraph 612.09.
In making this determination, we considered the following factors: (i) the length of time that Dr. Herschkowitz has held his
shares of common stock of the company, (ii) the circumstances surrounding the acquisition by Dr. Herschkowitz of his shares
of common stock of the company, (iii) the relationship between Dr. Herschkowitz and the company, (iv) Dr. Herschkowitz
is not in the business of underwriting securities, (v) the amount of shares being registered, and (vi) there was no indication
in the agreement or otherwise that Dr. Herschkowitz was in any way acting as a conduit for the company. Most important, these shares
were issued to Dr. Herschkowitz as an incentive to make a loan to the company that involved a substantial amount of risk, and he
has now held many of the shares to be registered for a year or more.

Therefore, Dr. Herschkowitz is not acting
as an underwriter for a distribution “by or on behalf of the company,” and the registration is not subject to the restrictions
of Rule 415(a)(4). The offering should be allowed to proceed as an “at the market” offering on behalf of selling shareholders
under Rule 415(a)(1)(i), (iii) and (iv) without compliance with the restrictions of Rule 415(a)(4).

Prospectus Cover Page

 2. It does not appear that your shares are quoted on
the OTC Bulletin Board as you state on the cover page to your prospectus. Given the lack of an established market for your shares,
please disclose the fixed price at which the shares will be sold. We will not object if you disclose that the shares will be sold
at the disclosed fixed price until your shares are quoted on the OTC Bulletin Board and thereafter at prevailing market prices
or privately negotiated prices.

The company’s shares are quoted on
the OTCQB. This is now disclosed on the cover page of the prospectus. This market represents an established market for the shares,
and we understand that the staff concurs with this position. Therefore, the sale of the shares need not be at a fixed price.

 3. On your prospectus cover page, please identify the
selling stockholders as underwriters. It is insufficient to state merely that they “may be deemed to be underwriters”
as you currently do on page 45.

Under “Plan of Distribution”
on pages 45 and 46, we have included customary language to the effect that the selling shareholders participating in the distribution
of the shares of common stock and any broker-dealer participating in such distribution will be deemed to be “underwriters”.
We have also revised the cover page of the prospectus to include this language.

However, as discussed in the response
to Comment 1.4 above, we do not believe Dr. Herschkowitz is acting as an underwriter in connection with this offering. Further,
the company does not believe the other selling shareholders are acting as underwriters. Therefore, the company does not believe
it is appropriate to identify the selling shareholders as underwriters.

Undertakings, page 56

 4. Please provide all undertakings required by Regulation
S-K Item 512, including those required by Item 512(a).

In Item 17, starting on page 45, we have
provided the undertakings required by Item 512(a).

Exhibit 5.1

 5. The last two paragraphs of this opinion do not accurately
reflect where counsel is named in your prospectus. Please file a revised opinion.

Exhibit 5.1 has been revised to reflect
where counsel is named in the prospectus.

* * * * *

Thank you for your consideration. If you
have any questions or further comments about these responses, please contact the undersigned at (651) 389-4806. Otherwise, please
confirm that the staff has no further comments, at which time we will submit an acceleration request, along with a written statement
as set forth on page 2 of your letter dated November 20, 2012.

Sincerely,

Bob Myers

Chief Financial Officer

cc:	Martin Rosenbaum, Maslon Edelman
Borman & Brand LLP

December 1 9, 2012
Via E -mail
Bob Myers
Chief Financial Officer
BioDrain Medical, Inc.
2915 Commers Drive, Suite 900
Eagan, Minnesota  55121

Re: BioDrain Medical , Inc.
 Form 10-K for the Fiscal Y ear Ended December 31, 2011
Filed April 16, 2012
File No. 000-54361

Dear Mr.  Myers :

We have comple ted our review of your filings .  We remind you that our comments or
changes to disclosure in response to our comments do not foreclose the Commission from taking
any action with respect  to the company or the filings  and the company may not assert staff
comments as a defense in any proceeding initiated by the Commission or any person under the
federal securities laws of the United States.  We urge all persons who are responsible for the
accuracy and adequacy of  the disclosure in the filings  to be certain that the filings include  the
information the Securities Exchange Act of 1934 and all applicable rules require.

Sincerely,

 /s/ Brian Cascio

Brian Cascio
Accounting Branch Chief

cc: Martin R. Rosenbaum

December 11, 2012
Via E -mail
Bob Myers
Chief Financial Officer
BioDrain Medical, Inc.
2915 Commers Drive, Suite 900
Eagan, Minnesota  55121

Re: BioDrain Medical , Inc.
 Form 10-K for the Fiscal Y ear Ended December 31, 2011
Filed April 16, 2012
File No. 000-54361

Dear Mr.  Myers :

We have reviewed your response dated December 5, 2012 and related filing s and have
the following comments.  We have limited our review to only your financial statements and
related disclosures and do not intend to expand our review to other portions of your documents.
In some of our comments, we may ask you to provide us with information so we may better
unders tand your disclosure.

Please respond to this letter within ten business days by amending your filing, by
providing the requested information, or by advising us when you will provide the requested
response.   If you do not believe our comments apply to your  facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.

After reviewing any amendment to your filing and the information you provide in
response to these  comments, we may have  additional comments.

Form 10 -K for the Fiscal Year Ended December 31, 2011

Item 9A. Controls and Procedures

Management’s Report on Internal Control over Financial Reporting, page 39

1. We note your response to prior comment 2.  While we note the references to material
weakness es in internal control structure, Item 303(a) (3) requires a statement indicating
whether or not internal control over financial reporting is effective as of the end of your
most recent fiscal year . Please amend your filing to comply with  Item 308(a)(3) of
Regulation S -K.

Bob Myers
BioDrain Medical, Inc.
December 11, 2012
Page 2

 You may contact Kristin Lochhead at (202) 551 -3664 or me at (202) 551 -3676 if you
have questions regarding comments on the financial statements and related matters.  Please
contact Martin James  at (202) 551 -3671 with any other questions.

Sincerely,

 /s/ Brian Cascio

Brian Cascio
Accounting Branch Chief

cc: Martin R. Rosenbaum

CORRESP
1
filename1.htm

BioDrain Medical, Inc.

	2915 Commers Drive,
Suite

	Eagan, Minnesota 55121

	 651.389.4806 phone

	 651.389.4807 fax

	 www.biodrainmedical.com

December 5, 2012

VIA EDGAR AND FEDERAL EXPRESS

Mr. Brian Cascio

Accounting Branch Chief

Securities and Exchange Commission

100 F Street NE

Washington, D.C. 20549

    Re:
    BioDrain Medical, Inc.

    Form 10-K for the fiscal year ended December 31, 2011

    Filed April 16, 2012

    Form 10-Q for the quarterly period ended September 30, 2012

    Filed November 15, 2012

    File No. 000-54361

Dear Mr. Cascio,

This letter responds on behalf of BioDrain
Medical, Inc. (the “Company”) to your comment letter addressed to the undersigned dated November 27, 2012 with respect
to the filings listed above. Included below are your comments and the corresponding responses supplied by the Company:

Form 10-K for the fiscal year ended
December 31, 2011

Item 7. Management’s Discussion
and Analysis of Financial Condition and Results of Operations

Revenue, page 36

Please reconcile the statement that revenue in 2011 included
the “sale” of five STEAMWAY FMS systems with the subsequent statement that during 2011 you began installing
the STREAMWAY FMS units in hospitals for evaluation purposes and, in one case, for production purposes. Please clarify the
nature of the sales recorded in 2011, and if these relate to actual sales of products or units placed at a customer site for evaluation
purposes.

BioDrain sold five STREAMWAY FMS units
to a customer during 2011. Separately, in 2011 BioDrain placed a STREAMWAY FMS unit with a different customer for production purposes,
as mentioned on page 36. Essentially, the customer took delivery of the unit on a trial basis and as a beta testing site, without
a commitment to purchase the unit. Revenue in 2011 related to the five sold units as well as sales of disposables; no revenue was
recognized in 2011 with respect to the unit that was delivered for production purposes.

In future filings, in discussing revenues
and unit sales in 2011, we will further clarify the distinction between the five sold units and the unit placed for production
purposes.

Item 9A. Controls and Procedures

Management’s Report on Internal
Control over Financial Reporting, page 39

We see that you identified a material weakness in your accounting
for stock options and warrants in your assessment of internal control over financial reporting (ICFR) at December 31, 2011. However,
we do not see where you disclosed your management’s conclusion that your ICFR was not effective as of that date. AS noted
in Item 308(a)(3) of Regulation S-K, management is not permitted to conclude that a registrant’s ICFR is effective if there
are one or more material weaknesses identified in the registrant’s ICFR. Please amend your filing to provide the statement
required by Item 308(a)(3) of Regulation S-K indicating whether or not your internal control over financial reporting was effective
at December 31, 2011.

After the end of fiscal 2011, BioDrain’s
management concluded that its internal control over financial reporting (ICFR) was not effective. Under “Management’s
Report on Internal Control over Financial Reporting,” BioDrain inadvertently failed to specifically report that conclusion.

However, BioDrain believes that the disclosure
does not imply any conclusion that ICFR was effective. First, the disclosure under this caption did not state or suggest a conclusion
that ICFR was effective. Second, in discussing its assessment of ICFR, management clearly stated that “. . . we identified
the following material weakness in our internal control structure . . .” and described the weakness, including the necessity
of audit adjustments that materially affected the company’s financial position and results of operations. Third, in the same
section, management discussed the company’s disclosure controls and procedures and clearly disclosed its conclusion that
its “ . . . disclosure controls and procedures were not effective.” Although disclosure controls and procedures involve
a separate evaluation process, we believe this statement reinforces the absence of any suggestion that ICFR was effective.

For the above reasons, BioDrain believes
the disclosure was not materially deficient under Item 308(a)(3), because the inadvertent omission of management’s conclusion
was not material. Therefore, BioDrain respectfully requests that the staff waive the request to amend Form 10-K, which would only
add a single clarifying sentence to the filing. In any future filing, in the description of management’s assessment of the
effectiveness of ICFR, BioDrain will clearly state management’s conclusion about such effectiveness or the lack thereof.
Further, in any such filing where a material weakness has been identified, BioDrain will clearly state that management concluded
that ICFR was not effective.

Form 10-Q for the quarterly period
ended September 30, 2012

Condensed Financial Statements

Note 1. Summary of Significant Accounting
Policies, Revenue Recognition, page 8

Please enhance the discussion of your revenue recognition policy
by addressing the following in future filings:

Discuss how you account for STEAMWAY FMS units placed
at a customer’s site for “evaluation”, including your depreciation policy for the related units;

Clarify if you ever provide a STEAMWAY FMS unit to
a customer free of charge and, if so, how you account for the arrangement;

Disclose if your customers ever have any minimum purchase
obligations for cleaning solution kits.

In future filings, BioDrain will enhance the discussion of its
revenue recognition policy by addressing the following:

 § We will discuss how we account for STREAMWAY FMS units
placed at a customer’s site for “evaluation,” including our depreciation policy for the related units;

 § We will clarify if we ever provide a STREAMWAY FMS
unit to a customer free of charge and, if so, how we account for the arrangement;

 § We will disclose if our customers ever have any minimum
purchase obligations for cleaning solution kits.

In addition, we acknowledge that:

we are responsible for the adequacy and accuracy of the disclosures
in the filing;

staff comments or changes to disclosures in response to staff comments
do not foreclose the Commission from taking any action with respect to the filing; and

we may not assert staff comments as a defense in any proceeding
initiated by the Commission or any person under the federal securities laws of the United States.

Thank you for your consideration. If you
have any questions or further comments about these responses, please contact the undersigned at (651) 389-4806.

Sincerely,

Bob Myers

Chief Financial Officer

cc:	Martin Rosenbaum, Maslon Edelman
Borman & Brand LLP

November 2 7, 2012
Via E -mail
Bob Myers
Chief Financial Officer
BioDrain Medical, Inc.
2915 Commers Drive, Suite 900
Eagan, Minnesota  55121

Re: BioDrain Medical , Inc.
 Form 10-K for the Fiscal Y ear Ended December 31, 2011
Filed April 16, 2012
Form 10 -Q for the quarterly period ended September 30, 2012
Filed November 15, 2012
File No. 000-54361

Dear Mr.  Myers :

We have reviewed your filing s and have the following comments.  We have limited our
review to only your financial statements and related disclosures and do not intend to expand our
review to other portions of your documents.  In some of our comments, we may ask you to
provide us with information so we may better unders tand your disclosure.

Please respond to this letter within ten business days by amending your filing, by
providing the requested information, or by advising us when you will provide the requested
response.   If you do not believe our comments apply to your  facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.

After reviewing any amendment to your filing and the information you provide in
response to these  comments, we may have  additional comments.

Form 10 -K for the fiscal year ended December 31, 2011

Item 7.  Management’s Discussion and Analysis of Financial Condition and Results of
Operations

Revenue, page 36

1. Please reconcile the statement that revenue in 2011 included the “sale” of five
STREAMWAY FMS systems with the subsequent statement that during 2011 you began
installing the STREAMWAY FMS units in hospitals for evaluation purposes and, in one
case, for production purposes.   Please clarify the nature of the sales recorded in 2011,

Bob Myers
BioDrain Medical, Inc.
November 2 7, 2012
Page 2

 and if these relate to actual sales of products or units placed at a customer site for
evaluation purposes.

Item 9A. Controls and Procedures

Management’s Report on Internal Control over Financial Reporting, page 39

2. We see that you identified a material we akness in your accounting for stock options and
warrants in your assessment of internal control over financial reporting (ICFR) at
December 31, 2011.   However, we do not see where you disclosed your management’s
conclusion that your ICFR was not effective as of that date. As noted in Item 308(a)(3) of
Regulation S -K, management is not permitted to conclude that a registrant’s ICFR is
effective if there are one or more material weaknesses identified in the registrant’s
ICFR.   Please amend your filing to prov ide the statement required by Item 308(a)(3) of
Regulation S -K indicating whether or not your internal control over financial reporting
was effective at December 31, 2011.

Form 10 -Q for the quarterly period ended September 30, 2012

Condensed Financial Statements

Note 1.  Summary of Significant Accounting Policies, Revenue Recognition, page 8

3. Please enhance the discussion of your revenue recognition policy by addressing the
following in future filings:

 Discuss how you account for STREAMWAY FMS units p laced at a customer’s site
for “evaluation,” including your depreciation policy for the related units;
 Clarify if you ever provide a STREAMWAY FMS unit to a customer free of charge
and, if so, how you account for the arrangement ;
 Disclose if your custome rs ever have any minimum purchase obligations for cleaning
solution kits.

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Exchange  Act of
1934 and all applicable Exchange Act rules require.   Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

 In responding to our comments, please provide  a written statement from the company
acknowledging that:

 the company is responsible for the adequacy and accuracy of the disclosure in the filing;
 staff comments or changes to disclosure in response to staff co mments do not foreclose
the Commission from taking any action with respect to the filing; and

Bob Myers
BioDrain Medical, Inc.
November 2 7, 2012
Page 3

  the company may not assert staff comments as a defense in any proceeding initiated by
the Commission or any person under the federal securities laws of the United  States.

You may contact Kristin Lochhead at (202) 551 -3664 or me at (202) 551 -3676 if you
have questions regarding comments on the financial statements and related matters.  Please
contact Martin James  at (202) 551 -3671 with any other questions.

Sincerely,

 /s/ Brian Cascio

Brian Cascio
Accounting Branch Chief

cc: Martin R. Rosenbaum

November 20 , 2012

Via E -mail
Joshua Kornberg
Chief Executive Officer
BioDrain Medical, Inc.
2915 Commers Drive, Suite 900
Eagan, Minnesota 55121

Re: BioDrain Medical, Inc.
 Registration Statement on Form S -1
Amendment No. 2  Filed November 5 , 2012
File No. 333 -179145

Dear Mr. Kornberg :

We have limited our review of your registration statement to those issues we have
addressed in our comments.  In  some of our comments, we may ask you to provide us with
information so we may better understand your disclosure.

Please respond to this letter by amending your registration statement and providing the
requested information .  Where you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.

After reviewing any amendment to your registration statement and the information you
provide in response to these  comments , we may have  additional comments.

1. Please respond to our comments 1 through 4 from our letter dated February 1 6, 2012.

Prospectus Cover Page

2. It does not appear that your shares are quoted on the OTC Bulletin Board as you state on
the cover page to  your prospectus.  Given the lack of an established market for your
shares, please disclose the fixed price at which the shares will be sold. We will not object
if you disclose that the shares will be sold at the disclosed fixed price until your shares
are quoted on the OTC Bulletin Board and thereafter at prevailing market prices or
privately negotiated prices.

3. On your prospectus cover page, please identify the selling stockholders as underwriters.
It is insufficient to state merely that they “may be deemed to be underwriters” as you
currently do on page 45.

Joshua Kornberg
BioDrain  Medical, Inc.
November 20, 2012
Page 2

Undertakings, page 56

4. Please provide all u ndertakings required by Regulation S -K Item 512, including those
required by Item 512(a).

Exhibit 5.1

5. The last two paragraphs of this opinion do not accurately reflect where counsel is named
in your pro spectus.  Please file a revised opinion.

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 193 3 and
all applicable Securities  Act rules require.   Since the company and its management are in
possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

Notwithstanding our comments, in the event  you request acceleration of the effective date
of the pending registration statement please provide a written statement from the company
acknowledging that:

 should the Commission or the staff, acting pursuant to delegated authority, declare the
filing ef fective, it does not foreclose the Commission from taking any action with respect
to the filing;

 the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in the filing; and

 the company  may not assert staff comments and the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.

Please refer to Rules 460 and 461 regarding requests for  acceleration .  We will consider a
written request for acceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of their respective responsibilities under
the Securities Act o f 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the securities specified in the above registration statement.  Please allow
adequate time  for us to review any amendment prior to the requested effective date of the
registration statement.

Joshua Kornberg
BioDrain  Medical, Inc.
November 20, 2012
Page 3

 Please contact Jay Mumford  at 202-551-3637 or me at 202 -551-3617  with any  questions.

Sincerely,

 /s/ Russell Mancuso

        Russell Mancuso
        Branch Chief

cc (via e-mail): Martin Rosenbaum, Esq .

February 16, 2012
 Via E-mail

Kevin R. Davidson Chief Executive Officer BioDrain Medical, Inc. 2060 Centre Point Blvd., Suite 7 Mendota Heights, Minnesota 55120
Re: BioDrain Medical, Inc.
 Registration Statement on Form S-1
Filed January 24, 2012 File No. 333-179145

Dear Mr. Davidson:
 We have limited our review of your registra tion statement to those issues we have
addressed in our comments.  In some of our comments, we may ask you to provide us with
information so we may better understand your disclosure.
 Please respond to this letter by amending your registration statement and providing the
requested information.  Where you do not beli eve our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
 After reviewing any amendment to your re gistration statement and the information you
provide in response to these comments , we may have additional comments.
 Prospectus Summary, page 1

 1. Please disclose prominently in your prospectus  summary the substantial doubt about your
ability to continue as a going concern as  mentioned in the notes to your financial
statements.
 Selling Security Holders, page 32

 2. Generally it is inconsistent w ith Section 5 of the Securities Act to register securities for
resale before the completion of the unregister ed issuance of those securities.  In this
regard, it appears that you have not received the consideration for the securities that
represent payment for attendance at future board meetings.  Also, it appears that the
conditions that would cause the issuance of the “Additional Bonus” and that would give
the investor the ability to enfo rce rights to the pledged shar es have not occurred.  Please
remove these shares from the registration statement or provide us a complete analysis

Kevin R. Davidson BioDrain Medical, Inc. February 16, 2012 Page 2

 demonstrating that it is appropria te to register the shares for resale at this time.  The
analysis that you provide in response to this comment shoul d cite with specificity and
analyze the relevant authority and guidance.
 3. We note the statement in your Form 8-K filed December 27, 2011 that you issued
1,500,000 shares on December 22, 2011.  Please tell  us why the difference between the
number of outstanding shares on November  1, 2011 as reported on the facing page of
your most recent Form 10-Q and January 24, 2012 as disclosed on page 51 of this S-1 is significantly less than  1,500,000 shares.
 4. From Section 4.03 of exhibit 10.29, we note that  the selling stockholder participated in
designating the individual who will oversee your program that uses a portion of the proceeds from the selling stockholder to promot e the market for your securities, including
the securities offered by the se lling stockholder.  Please provid e us a detailed analysis
supporting your conclusions regarding whethe r the selling stockholder is an underwriter
of the offering registered on this Form S-1.  If the selling stockholder is an underwriter
and you are not eligible to use Form S-3, pleas e disclose on the prospectus cover and in
your “Plan of Distribution” the fixed price at which the secu rities will be sold throughout
the duration of the offering.
Executive Compensation, page 47

 5. Please update your executive compensation disc losure to include the most recently
completed fiscal year.
 Exhibit 5.1

6. Please tell us why the opinion indicates that th e offered shares are currently issued when
it appears that you have not yet issued all of the shares.

We urge all persons who are responsible for th e accuracy and adequacy of the disclosure
in the filing to be certain that the filing incl udes the information the Securities Act of 1933 and
all applicable Securities Act rules require.  Since the company and its management are in
possession of all facts relating to a company’s disc losure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
Notwithstanding our comments, in the event you request acceleration of  the effective date
of the pending registration statement please pr ovide a written statement from the company
acknowledging that:

 should the Commission or the staff, acting purs uant to delegated authority, declare the
filing effective, it does not foreclose the Co mmission from taking any action with respect
to the filing;

Kevin R. Davidson BioDrain Medical, Inc. February 16, 2012 Page 3

 the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in the filing; and

 the company may not assert staff comments a nd the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.  Please refer to Rules 460 and 461 regarding re quests for acceleration.  We will consider a
written request for acceleration of  the effective date of the regi stration statement as confirmation
of the fact that those reques ting acceleration are aware of thei r respective responsibilities under
the Securities Act of 1933 and the Securities Excha nge Act of 1934 as they relate to the proposed
public offering of the securities specified in th e above registration stat ement.  Please allow
adequate time for us to review any amendment prior to the requested effective date of the
registration statement.
 Please contact Jay Mumford at 202-551-3637 or me at 202-551-3617 with any questions.

Sincerely,
  /s/ Russell Mancuso
         R u s s e l l  M a n c u s o          B r a n c h  C h i e f   cc (via e-mail): Peter Hogan, Esq.

CORRESP
1
filename1.htm

    Unassociated Document

    BioDrain
Medical, Inc.

    2060
Centre Pointe Boulevard, Suite 7

    Mendota
Heights, Minnesota 55120

    October
15, 2009

    VIA FACSIMILE AND
EDGAR

    Securities
and Exchange Commission

    450 Fifth
Street, N. W.

    Washington,
D.C. 20549

                Re:

                BioDrain Medical,
      Inc.

                Registration
      Statement – Form S-1 (Registration No.
  333-155299)

    Ladies
and Gentlemen:

    BioDrain
Medical, Inc.. (the “Company”) hereby requests that the Commission take
appropriate action to cause the above-referenced registration statement on Form
S-1 to become effective on October 19, 2009 at 9:00 a.m. Washington, D.C.
time.

                Very
      truly yours,

                BIODRAIN MEDICAL, INC.

                By:

              /s/ Kevin
      Davidson

              Kevin
      Davidson

                Chief
      Executive Officer

CORRESP
1
filename1.htm

    BioDrain
Medical, Inc.

    2060
Centre Pointe Boulevard, Suite 7

    Mendota
Heights, Minnesota 55120

    October
15, 2009

    VIA FACSIMILE AND
EDGAR

    Securities
and Exchange Commission

    450 Fifth
Street, N. W.

    Washington,
D.C. 20549

              Re:

              BioDrain
      Medical, Inc.

                Registration
      Statement – Form S-1 (Registration No.
  333-155299)

    Ladies
and Gentlemen:

    BioDrain
Medical, Inc. (the “Company”) hereby requests that the Commission take
appropriate action to cause the above-referenced registration statement on Form
S-1 to become effective on October 19, 2009 at 9:00 a.m. Washington, D.C.
time.

    The
Company hereby acknowledges the following:

              ·

              should
      the Commission or the staff, acting pursuant to delegated authority,
      declare the filing effective, it does not foreclose the Commission from
      taking any action with respect to the
filing;

              ·

              the
      action of the Commission or the staff, acting pursuant to delegated
      authority, in declaring the filing effective, does not relieve the company
      from its full responsibility for the adequacy and accuracy of the
      disclosure in the filing; and

              ·

              the
      company may not assert staff comments and the declaration of effectiveness
      as a defense in any proceeding initiated by the Commission or any person
      under the federal securities laws of the United
  States.

                  Very
      truly yours,

                  BIODRAIN
      MEDICAL, INC.

                  By:

                  /s/ Kevin Davidson

                  Kevin
      Davidson

                  Chief
      Executive
Officer

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

       DIVISION OF
CORPORATION FINANCE
     Mail Stop 3030
        October 6, 2009
 Kevin R. Davidson Chief Executive Officer 2060 Centre Pointe Boulevard, Suite 7 Mendota Heights, Minnesota  55120
Re: BioDrain Medical, Inc.
Amendment No. 10 to Registration Statement on Form S-1 Filed September 30, 2009
  File No. 333-155299

Dear Mr. Davidson:

We have reviewed your filing and have the following comments.  Where
indicated, we think you should re vise your document in response to these comments.  If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary.  Please be as deta iled as necessary in your explanation.  In
some of our comments, we may ask you to provi de us with information so we may better
understand your disclosure.  After reviewing th is information, we may raise additional
comments.
We welcome any questions you may have  about our comments or any other
aspect of our review.  Feel fr ee to call us at the telephone numbe rs listed at the end of this
letter.
Exhibits

1. Please provide a currently dated accountant's consent with the amendment to be declared effective.
 Exhibit 5.1

2. Refer to the last paragraph.  The consen t provided by counsel must include its
consent to the filing of the opinion as an exhibit.  Please file a revised opinion.
3. While counsel may state that it “does not admit” that it is an expert, it is
inappropriate for counsel to deny that it is an expert.  Please have counsel revise
the last sentence of its opinion accordingly.

Kevin R. Davidson
BioDrain Medical, Inc. October 6, 2009 Page 2
*  *  *  *  *  *  *
As appropriate, please amend your regist ration statement in response to these
comments.  You may wish to provide us with marked copies of the amendment to expedite our review.  Please furnish a cove r letter with your amendment that keys your
responses to our comments and provides any requested information.  Detailed cover
letters greatly facilitate our review.  Please understand that we may have additional comments after reviewing your amendmen t and responses to our comments.
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filing to be certain that the filing includes all in formation required under
the Securities Act of 1933 and that they have  provided all information investors require
for an informed investment decision.  Since the company and its management are in possession of all facts relating to a company’ s disclosure, they are responsible for the
accuracy and adequacy of the disclosures they have made.       In addition, please be advi sed that the Division of En forcement has access to all
information you provide to the staff of the Di vision of Corporation Finance in connection
with our review of your filing or in response to our comments on your filing.
We will consider a written request for acceleration of the effective date of the
registration statement as conf irmation of the fact that t hose requesting acceleration are
aware of their respective re sponsibilities under the S ecurities Act of 1933 and the
Securities Exchange Act of 1934 as they rela te to the proposed public offering of the
securities specified in the above registration statement.  We will act  on the request and,
pursuant to delegated authority, grant acce leration of the effective date.
We direct your attention to Rules 46 0 and 461 regarding requesting acceleration
of a registration statement.  Please allow ad equate time after the filing of any amendment
for further review before submitting a request for acceleration.  Please provide this request at least two business days in a dvance of the requested effective date.
 You may contact Kristin Lochhead at (202) 551-3664 or Gary Todd, Reviewing
Accountant, at (202) 551-3605 if you have  questions regarding comments on the
financial statements and related matters.  Pl ease contact Geoffrey Kruczek at (202) 551-
3641 or me at (202) 551-3800 with any other questions.

    S i n c e r e l y ,
Peggy Fisher Assistant Director
cc (via fax): Ryan Hong, Esq.—Richardson & Patel LLP

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

       DIVISION OF
CORPORATION FINANCE
     Mail Stop 3030
        August 28, 2009
 Kevin R. Davidson Chief Executive Officer 2060 Centre Pointe Boulevard, Suite 7 Mendota Heights, Minnesota  55120
Re: BioDrain Medical, Inc.
Amendment No. 8 to Registrati on Statement on Form S-1
Filed August 20, 2009
  File No. 333-155299

Dear Mr. Davidson:

We have reviewed your filing and have the following comments.  Where
indicated, we think you should re vise your document in response to these comments.  If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary.  Please be as deta iled as necessary in your explanation.  In
some of our comments, we may ask you to provi de us with information so we may better
understand your disclosure.  After reviewing th is information, we may raise additional
comments.
We welcome any questions you may have  about our comments or any other
aspect of our review.  Feel fr ee to call us at the telephone numbe rs listed at the end of this
letter.
Risk Factors

We are an early stage company . . ., page 4

1. We reissue prior comment 1 given your disclosure here that you “have not
generated any revenues to date.”

Six months ended June 30, 2009 and 2008, page 22

2. Please revise to separately quantify the am ount of revenue generated from the sale
of your FMS unit and that amount generated from the sale of the cleaning solution
kits.

Kevin R. Davidson
BioDrain Medical, Inc.
August 28, 2009 Page 2  3. Please revise to also discuss the nature a nd composition of cost of sales, including
a discussion of gross margin.

Consolidated Financial Statements

Note 1.  Summary of Significant Accounting Policies, page F-6

4. Please revise to add a discussion of your accounting policy for revenue recognition.  To the extent relevant, please also addre ss post shipment obligations,
customer acceptance provisions, return policies, warranties, credits and discounts, rebates, price protection or similar privil eges and the impact of these matters on
the amounts and timing of revenues.  Pl ease also address how the installation
requirements described on pages 41 a nd 49 impact the timing of revenue
recognition.   The disclosure in critical accounting policies on page 19 should similarly be revised to discuss the judg ments and uncertainties  inherent in your
revenue recognition policy.
 5. As a related matter, we see that you also sell disposable clean ing kits and that you
expect the sale of the kits to be a su bstantial ongoing revenu e generator.  Please
disclose your accounting policy with respect to these kits , if different from the
sale of the Fluid Management System (FMS) unit.  Discuss if there are any
minimum purchase requirements of the cleaning kits with the purchase of the
FMS.  If so, discuss how the requirement impacts your revenue recognition
policy.
 Note 3.  Stockholders’ Deficit, Stoc k Options and Warrants, page F-7

 Other Securities For Issuance Upon Ce rtain Contingencies, page F-11

 6. We see that the vesting of certain se curities were con tingent on achieving
commercial sales of the FMS.  Since you began recognizing revenue on sales of
the FMS in June 2009, please update this se ction to disclose the vesting of and
accounting for those securities.
 7. We reference the agreement with Pete r Morawetz dated May 15, 2009 in which
Mr. Morawetz, a significant shareholder, waived unpaid consulting fees in return
for cash and equity.  Please revise the re levant paragraph on pa ge F-11 to explain
that the waived amount was recorded as a contribution to capital as reflected in
the statement of stockholders’ equity.
 Note 8.  Long-term Debt, page F-13

 8. We see that you accrued the cash portion of the liquidated damages requirement
under the $170,000 note payable.  Please revi se to also disclose the amount you

Kevin R. Davidson
BioDrain Medical, Inc.
August 28, 2009 Page 3
have accrued for the shares you are obligat ed to issue to the investors on June 30,
2009.  Please refer to FASB ASC 825-20-30-5.

*  *  *  *  *  *  *
    As appropriate, please amend your regist ration statement in response to these
comments.  You may wish to provide us with marked copies of the amendment to expedite our review.  Please furnish a cove r letter with your amendment that keys your
responses to our comments and provides any requested information.  Detailed cover
letters greatly facilitate our review.  Please understand that we may have additional comments after reviewing your amendmen t and responses to our comments.
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filing to be certain that the filing includes all in formation required under
the Securities Act of 1933 and that they have  provided all information investors require
for an informed investment decision.  Since the company and its management are in possession of all facts relating to a company’ s disclosure, they are responsible for the
accuracy and adequacy of the disclosures they have made.       In addition, please be advi sed that the Division of En forcement has access to all
information you provide to the staff of the Di vision of Corporation Finance in connection
with our review of your filing or in response to our comments on your filing.
We will consider a written request for acceleration of the effective date of the
registration statement as conf irmation of the fact that t hose requesting acceleration are
aware of their respective re sponsibilities under the S ecurities Act of 1933 and the
Securities Exchange Act of 1934 as they rela te to the proposed public offering of the
securities specified in the above registration statement.  We will act  on the request and,
pursuant to delegated authority, grant acce leration of the effective date.
We direct your attention to Rules 46 0 and 461 regarding requesting acceleration
of a registration statement.  Please allow ad equate time after the filing of any amendment
for further review before submitting a request for acceleration.  Please provide this request at least two business days in a dvance of the requested effective date.
 You may contact Kristin Lochhead at (202) 551-3664 or Gary Todd, Reviewing
Accountant, at (202) 551-3605 if you have  questions regarding comments on the

Kevin R. Davidson
BioDrain Medical, Inc. August 28, 2009 Page 4  financial statements and related matters.  Pl ease contact Geoffrey Kruczek at (202) 551-
3641 or me at (202) 551-3800 with any other questions.

    S i n c e r e l y ,
Peggy Fisher Assistant Director
  cc (via fax): Ryan Hong, Esq.—Richardson & Patel LLP

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

       DIVISION OF
CORPORATION FINANCE
     Mail Stop 3030
        August 18, 2009  Kevin R. Davidson Chief Executive Officer 2060 Centre Pointe Boulevard, Suite 7 Mendota Heights, Minnesota  55120
Re: BioDrain Medical, Inc.
Amendment No. 7 to Registrati on Statement on Form S-1
Filed August 12, 2009
  File No. 333-155299

Dear Mr. Davidson:

We have reviewed your filing and have the following comments.  Where
indicated, we think you should re vise your document in response to these comments.  If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary.  Please be as deta iled as necessary in your explanation.  In
some of our comments, we may ask you to provi de us with information so we may better
understand your disclosure.  After reviewing th is information, we may raise additional
comments.
We welcome any questions you may have  about our comments or any other
aspect of our review.  Feel fr ee to call us at the telephone numbe rs listed at the end of this
letter.
Risk Factors

Our limited operating history . . ., page 3

1. It appears from your disclosures on page s 18 and 32 that you have recently begun
generating revenues.  However, your disclo sures here and on page 4 state that you
have not generated any revenues to date.  Please reconcile.  Al so ensure that the
remainder of your document accurately reflects the status of your revenue-
producing activities.

Kevin R. Davidson
BioDrain Medical, Inc.
August 18, 2009 Page 2   Summary Compensation Table, page 62

 2. We note your response to prior comment 7.  Refer to the penultimate column of
Exhibit 10.50, which is captioned “Future Ca sh.”  Please reconcile the number in
that column for Mr. Rice with your disclosure here and page 69, which
disclosures indicate that Mr. Rice will  receive a one-time cash payment of
$46,000.

Employment Agreements, page 64

3. Refer to the penultimate paragraph on page 66, where you discuss the vesting of
options granted to Mr. Ruwe.  Please reconcile your disclosure  there and on page
32 regarding the number of options  that have vested to date.
 Financial Statements

4. Please update your financial statements as  required by Rule 8-08 of Regulation S-
X.

Note 3, Stockholders’ Deficit, Stoc k Options and Warrants, page F-7
 Other Securities For Issuance Upon Ce rtain Contingencies, page F-11

5. Previously you disclosed that $346,700 of accrued salaries was forgiven by
certain officers and directors in December 2007.  Please tell us why the disclosure
now indicates that the salaries were forgiven in June 2008.

Note 11,  Restatement of 2007 and 2008, page F-14

6. We note the revisions made in response to prior comment 6.  However, it appears
that at least one of the cro ss references between the itemi zed tables is not correct.
For example, for 2008, it appears that the adjustment to accrued expenses should
only be attributed to footnote (14) and that footnote (9) is not applicable to this
adjustment.   Please proof to ensure th at all footnotes are appropriately cross
referenced.

*  *  *  *  *  *  *

Kevin R. Davidson
BioDrain Medical, Inc. August 18, 2009 Page 3
As appropriate, please amend your regist ration statement in response to these
comments.  You may wish to provide us with marked copies of the amendment to expedite our review.  Please furnish a cove r letter with your amendment that keys your
responses to our comments and provides any requested information.  Detailed cover
letters greatly facilitate our review.  Please understand that we may have additional comments after reviewing your amendmen t and responses to our comments.
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filing to be certain that the filing includes all in formation required under
the Securities Act of 1933 and that they have  provided all information investors require
for an informed investment decision.  Since the company and its management are in possession of all facts relating to a company’ s disclosure, they are responsible for the
accuracy and adequacy of the disclosures they have made.       In addition, please be advi sed that the Division of En forcement has access to all
information you provide to the staff of the Di vision of Corporation Finance in connection
with our review of your filing or in response to our comments on your filing.
We will consider a written request for acceleration of the effective date of the
registration statement as conf irmation of the fact that t hose requesting acceleration are
aware of their respective re sponsibilities under the S ecurities Act of 1933 and the
Securities Exchange Act of 1934 as they rela te to the proposed public offering of the
securities specified in the above registration statement.  We will act  on the request and,
pursuant to delegated authority, grant acce leration of the effective date.
We direct your attention to Rules 46 0 and 461 regarding requesting acceleration
of a registration statement.  Please allow ad equate time after the filing of any amendment
for further review before submitting a request for acceleration.  Please provide this request at least two business days in a dvance of the requested effective date.
 You may contact Kristin Lochhead at (202) 551-3664 or Gary Todd, Reviewing
Accountant, at (202) 551-3605 if you have  questions regarding comments on the
financial statements and related matters.  Pl ease contact Geoffrey Kruczek at (202) 551-
3641 or me at (202) 551-3800 with any other questions.

    S i n c e r e l y ,
Peggy Fisher Assistant Director
  cc (via fax): Ryan Hong, Esq.—Richardson & Patel LLP

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

       DIVISION OF
CORPORATION FINANCE
     Mail Stop 3030
        August 7, 2009
 Kevin R. Davidson Chief Executive Officer 2060 Centre Pointe Boulevard, Suite 7 Mendota Heights, Minnesota  55120
Re: BioDrain Medical, Inc.
Amendment No. 6 to Registrati on Statement on Form S-1
Filed July 31, 2009
  File No. 333-155299

Dear Mr. Davidson:

We have reviewed your filing and have the following comments.  Where
indicated, we think you should re vise your document in response to these comments.  If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary.  Please be as deta iled as necessary in your explanation.  In
some of our comments, we may ask you to provi de us with information so we may better
understand your disclosure.  After reviewing th is information, we may raise additional
comments.
We welcome any questions you may have  about our comments or any other
aspect of our review.  Feel fr ee to call us at the telephone numbe rs listed at the end of this
letter.
The Offering, page 1

1. Please reconcile your disclosures here and on page 14 regarding the number of shares of common stock remaining a nd reserved for issuance under your 2008
Equity Incentive Plan.  Also reconcile your disclosures here and on pages 14, II-7
and II-8 regarding the number of common shares underlying warrants that are not being registered for resale.  It appear s from your disclosure here that 1,480,220
shares underlie those outstanding warrant s, while your disclosures on pages 14,
II-7 and II-8 indicate that 1,530,220 shares  underlie those outstanding warrants.

Kevin R. Davidson
BioDrain Medical, Inc.
August 7, 2009 Page 2  Selling Security Holders, page 69

 2. According to notes 8 and 22, you included the option to purchase 250,000 shares in the second column for Chad Ruwe.  Your disclosure on pages 75-76 indicates
that a portion of the shares underlying th at option were not included for purposes
of calculating Mr. Ruwe’s beneficial ownership because that portion is not
exercisable.  Please reconcile.

Financial Statements

3. Please update your financial statements wh en required by Rule 8-08 of Regulation
S-X.

Note 11.  Restatement of 2007 and 2008, page F-14

4. As you have also restated the accumulated deficit, please revise to add the item
“Deficit accumulated during the development stage” to the balance sheet
restatement tables.
5. We note the revisions made in response  to prior comment 13.  However, it
appears that certain of the cross referen ces between the narrati ve and the tables
are not complete.  For example, for 2007, it appears that th e adjustments to
current and long-term debt should also be attributed to footnote (5) and the
adjustments to additional paid-in capital should  also be attributed to footnote (4).
Please revise.
6. As a related matter, for 2008, we are unable to reconcile the adjustments from the
tables on page F-15 to the footnotes in th e narrative on page F-14.  Please show us
how the “net change” reconciles to the discussion of the restatement items on
page F-14.  Please appropriatel y clarify the disclosure.

Item 26.  Recent Sales of Unregistered Securities, page II-4

7. Please disclose the information required by Regulation S-K Item 701 with respect
to the option issuance to Mr. Morawetz me ntioned on page 69.  Also file as an
exhibit the agreement with Mr. Morawetz re lated to the waiver of consulting fees.
   8. Your new disclosure on page II-8 indicat es that you engaged in two unregistered,
identical transactions on June 10, 2009 w ith Citigroup FBO John Villas.  With a
view toward clarified disclosure, please tell us the reasons for the multiple identical transactions on the same date.

*  *  *  *  *  *  *

Kevin R. Davidson
BioDrain Medical, Inc. August 7, 2009 Page 3
As appropriate, please amend your regist ration statement in response to these
comments.  You may wish to provide us with marked copies of the amendment to expedite our review.  Please furnish a cove r letter with your amendment that keys your
responses to our comments and provides any requested information.  Detailed cover
letters greatly facilitate our review.  Please understand that we may have additional comments after reviewing your amendmen t and responses to our comments.
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filing to be certain that the filing includes all in formation required under
the Securities Act of 1933 and that they have  provided all information investors require
for an informed investment decision.  Since the company and its management are in possession of all facts relating to a company’ s disclosure, they are responsible for the
accuracy and adequacy of the disclosures they have made.       In addition, please be advi sed that the Division of En forcement has access to all
information you provide to the staff of the Di vision of Corporation Finance in connection
with our review of your filing or in response to our comments on your filing.
We will consider a written request for acceleration of the effective date of the
registration statement as conf irmation of the fact that t hose requesting acceleration are
aware of their respective re sponsibilities under the S ecurities Act of 1933 and the
Securities Exchange Act of 1934 as they rela te to the proposed public offering of the
securities specified in the above registration statement.  We will act  on the request and,
pursuant to delegated authority, grant acce leration of the effective date.
We direct your attention to Rules 46 0 and 461 regarding requesting acceleration
of a registration statement.  Please allow ad equate time after the filing of any amendment
for further review before submitting a request for acceleration.  Please provide this request at least two business days in a dvance of the requested effective date.
 You may contact Kristin Lochhead at (202) 551-3664 or Gary Todd, Reviewing
Accountant, at (202) 551-3605 if you have  questions regarding comments on the
financial statements and related matters.  Pl ease contact Geoffrey Kruczek at (202) 551-
3641 or me at (202) 551-3800 with any other questions.

    S i n c e r e l y ,
Peggy Fisher Assistant Director
  cc (via fax): Ryan Hong, Esq.—Richardson & Patel LLP

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

       DIVISION OF
CORPORATION FINANCE
     Mail Stop 3030
        July 21, 2009
 Kevin R. Davidson Chief Executive Officer 2060 Centre Pointe Boulevard, Suite 7 Mendota Heights, Minnesota  55120
Re: BioDrain Medical, Inc.
Amendment No. 5 to Registrati on Statement on Form S-1
Filed July 1, 2009
  File No. 333-155299

Dear Mr. Davidson:

We have reviewed your filing and have the following comments.  Where
indicated, we think you should re vise your document in response to these comments.  If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary.  Please be as deta iled as necessary in your explanation.  In
some of our comments, we may ask you to provi de us with information so we may better
understand your disclosure.  After reviewing th is information, we may raise additional
comments.
We welcome any questions you may have  about our comments or any other
aspect of our review.  Feel fr ee to call us at the telephone numbe rs listed at the end of this
letter.
Risk Factors, page 3

1. Given your deletions on page 34, it appear s you no longer intend to register a
class of your securities under the Exch ange Act.  Therefore, please:

• disclose the risks related to termina tion of periodic disclosure due to the
automatic reporting suspensi on under Section 15(d) of th e Exchange Act; and
• explain the effect of the inapplicability of the proxy rules and Section 16 of
the Exchange Act.
 Three months ended March 31, 2009 and 2008, page 25

 2. Please disclose your response to the second bullet of prior comment 7.

Kevin R. Davidson
BioDrain Medical, Inc.
July 21, 2009 Page 2  Private Placement Financing, page 34

  3. Please tell us the reasons for the dele tions here and on page 79 regarding the
provision that limited exercise of the warrants.  If that provision is no longer
applicable to those securities, please ensure that the disclosures you provided
pursuant to Items 403 and 507 of Regulat ion S-K are updated accordingly.  Also
note that it is generally in consistent with Section 5 of the Securities Act to
renegotiate the terms of a private o ffering while the related securities are
registered for resale.
 Handling Costs, page 47

 4. We note your response to prior comment 12.  Please clarify for investors that the
study you cite in the last pa ragraph involved a total of 31 exposures, the majority
of which were percutaneous exposures, which are more costly for hospitals to address.  Also revise to clarify your  cost estimates for non-percutaneous
exposures, as previously requested.

Directors, Executive Officers, Promoters and Control Persons, page 58

5. We note your response to prior comment 15.  Please reconcile your response
regarding Mr. Shuler’s “assisting Mr. Da vidson in the financial record keeping
area” with the statements on your web si te under the caption “Management” that
Mr. Shuler is your “Acting Ch ief Financial Officer.”
 Security Ownership, page 76

 6. We reissue prior comment 19:

• You disclose in note 12 that the followi ng shares are included in the table for
Mr. Patel—412,411 shares of common stock, 45,595 shares underlying warrants, 45,595 shares underlying convert ible notes and 183,991 shares held
by RP Capital.  Adding those numbers equals 687,592, not the 641,997 included in the table on page 77; and
• You disclose in note 13 that the followi ng shares are included in the table for
Mr. Richardson—399,543 shares of co mmon stock, 45,595 shares underlying
warrants, 45,595 shares underlying convert ible notes and 183,991 shares held
by RP Capital.  Adding those numbers equals 674,724, not the 629,129 included in the table on page 77.

Kevin R. Davidson
BioDrain Medical, Inc.
July 21, 2009 Page 3
Warrants and Convertible Debt, page 79

 7. Please expand your revisions in response to prior comment 20 to clarify when you intend to issue the shares and pay the pena lties mentioned.  Also tell us how your
disclosure on pages 70, 71-73 and 77 accounts for the penalties you are obligated to pay and shares you are obligated to issue.
 Report of Independent Registered Public Accounting Firm, page F-1

8. As the development stage cumulative fina ncial information has been updated to
March 31, 2009, an unaudited cumulative pe riod, please tell us why the audit
report continues to indicate that de velopment stage cumulative financial
information through December 31, 2008 is  included in the accompanying
financial statements.  In that regard, pleas e have the auditor either (1) modify the
report to indicate that the development stage cumulative financial information
through December 31, 2008 is not separa tely presented in the accompanying
financial statements or (2) delete th e references to the development stage
cumulative financial information through December 31, 2008 as that data is no
longer separately presented in th e accompanying financial statements.

9. Please note that there appears to be a t ypographical error in th e fourth sentence of
the second paragraph of the audit repo rt.  Please appropriately revise.

Statement of Operations, page F-3
 10. Please revise so that the net loss for the three months ended March 31, 2008 as
presented on the statement of operations is the same amount as that presented on
the statement of cash flows for that period.

Note 1, Summary of Significant Accounting Policies, page F-6

11. Please revise to the provide the manage ment representation regarding interim
financial statements that is required by Instruction 2 to Rule 8-03 of Regulation S-
X.

Note 8, Long-Term Debt, page F-12

12. Please disclose how you are accounting fo r the registration payment obligation
described under the tabular data.  In that  regard, please add di sclosure explaining
how you have applied the guidance from FASB ASC 825-20.  As you appear to

Kevin R. Davidson
BioDrain Medical, Inc.
July 21, 2009 Page 4
have incurred obligations as of Ma rch 31, 2009, please disclose the amount
accrued pursuant to FASB ASC 825-20-50- 1.  If no amounts have been accrued,
please tell us how your accounting is appropriate under the cited guidance and FASB ASC 450-20.
 Note 11.  Restatement of 2007 and 2008, page F-13

13. Please revise to clearly disclose how the “net change” for each restated financial
statement line item reconciles to the narrative discussion of the individual
restatement adjustments.  For instan ce, you could provide cross references
between tabular data and the narrative lin king the explanations  of the components
to the net changes or expand the tabular data  to show the separate impact of each
separate restatement adjustment described in the narrative.
 Note 12.  Liability for Equity-Linked Financial Instruments, page F-15

14. We see that you recorded the fair value of the warrants with round down
provisions at January 1, 2009 as a reduction to paid-in capital.  Please help us
better understand how you have applied the guidance from para graph 21 of EITF
07-05 (ASC FASB 815-10-65-3).  Under the cited guidance, the cumulative-effect
of adoption is the difference between th e amounts recognized in the statement of
financial position before initial app lication of the Issue and the amounts
recognized in the statement of financial posit ion at initial applica tion of the Issue.
The amounts recognized at in itial application (that is , January 1, 2009) should be
based on the amounts that would have b een recognized had the warrants been
accounted for as derivatives from the date of  issuance.  In that regard please tell
us:
• The estimated fair value of the wa rrants at the date of issuance.
• The change in the fair value of the wa rrants from the date of issuance to the
date of adoption (that is , January 1, 2009), if any.
• Why the cumulative effect of adopti on as presented on the statement of
stockholders’ equity should not separate ly show the initial fair value at
issuance of the warrants as an adjustme nt to paid-in-capital with the pre-
adoption change in fair value shown as an adjustment to the accumulated
deficit, both amounts recognized as of January 1, 2009.
 That is, while we understand that th e fair value of th e warrants (and net
cumulative impact of adopti on) is estimated to be  $479,910 as of January 1, 2009,
please explain to us how the presentation of  the impact of adoption as reflected on
the statement of stockholders’ equ ity reflects the cited guidance.

Kevin R. Davidson
BioDrain Medical, Inc.
July 21, 2009 Page 5  Item 27.  Exhibits, page II-8

 15. We note your response to prior comment 14.  We previously requested that you
resolve all comments regarding your request  prior to requesting effectiveness of
this registration statement.  You informed  us in your response letter dated May
14, 2009 that you would submit a confidential treatment request “shortly.”  Please
note that we have not yet received your application for confidential treatment and, as we previously informed you, you should resolve all comments  regarding that
request prior to requesting effectiveness of this registration statement.

*  *  *  *  *  *  *

As appropriate, please amend your regist ration statement in response to these
comments.  You may wish to provide us with marked copies of the amendment to expedite our review.  Please furnish a cove r letter with your amendment that keys your
responses to our comments and provides any requested information.  Detailed cover
letters greatly facilitate our review.  Please understand that we may have additional comments after reviewing your amendmen t and responses to our comments.
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filing to be certain that the filing includes all in formation required under
the Securities Act of 1933 and that they have  provided all information investors require
for an informed investment decision.  Since the company and its management are in possession of all facts relating to a company’ s disclosure, they are responsible for the
accuracy and adequacy of the disclosures they have made.       In addition, please be advi sed that the Division of En forcement has access to all
information you provide to the staff of the Di vision of Corporation Finance in connection
with our review of your filing or in response to our comments on your filing.
We will consider a written request for acceleration of the effective date of the
registration statement as conf irmation of the fact that t hose requesting acceleration are
aware of their respective re sponsibilities under the S ecurities Act of 1933 and the
Securities Exchange Act of 1934 as they rela te to the proposed public offering of the
securities specified in the above registration statement.  We will act  on the request and,
pursuant to delegated authority, grant acce leration of the effective date.
We direct your attention to Rules 46 0 and 461 regarding requesting acceleration
of a registration statement.  Please allow ad equate time after the filing of any amendment
for further review before submitting a request for acceleration.  Please provide this request at least two business days in a dvance of the requested effective date.

Kevin R. Davidson
BioDrain Medical, Inc. July 21, 2009 Page 6
You may contact Kristin Lochhead at (202) 551-3664 or Gary Todd, Reviewing
Accountant, at (202) 551-3605 if you have  questions regarding comments on the
financial statements and related matters.  Pl ease contact Geoffrey Kruczek at (202) 551-
3641 or me at (202) 551-3800 with any other questions.

    S i n c e r e l y ,
Peggy Fisher Assistant Director
  cc (via fax): Ryan Hong, Esq.—Richardson & Patel LLP

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

       DIVISION OF
CORPORATION FINANCE
     Mail Stop 3030
        June 5, 2009
 Kevin R. Davidson Chief Executive Officer 2060 Centre Pointe Boulevard, Suite 7 Mendota Heights, Minnesota  55120
Re: BioDrain Medical, Inc.
Amendment No. 4 to Registrati on Statement on Form S-1
Filed May 14, 2009
  File No. 333-155299

Dear Mr. Davidson:

We have reviewed your filing and have the following comments.  Where
indicated, we think you should re vise your document in response to these comments.  If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary.  Please be as deta iled as necessary in your explanation.  In
some of our comments, we may ask you to provi de us with information so we may better
understand your disclosure.  After reviewing th is information, we may raise additional
comments.
We welcome any questions you may have  about our comments or any other
aspect of our review.  Feel fr ee to call us at the telephone numbe rs listed at the end of this
letter.
Fee Table

1. Refer to prior comment 2 in our letter dated February 24, 2009 and tell us why
your fee table has been revised to refer to the maximum offering price of “N/A,” given your disclosure that the selling shar eholders will sell at the fixed price of
$0.46 per share until your shares are quoted  on the Over-the-Counter Bulletin
Board.

Prospectus Summary, page 1

2. Your disclosure here and on page 49 indi cates that you have not yet requested or
received FDA regulatory clearance to market or sell our products.  Your

Kevin R. Davidson
BioDrain Medical, Inc.
June 5, 2009 Page 2
disclosure on pages 6, 24 and 30 indicate that you received “final” FDA clearance
on April 1, 2009.  Please reconcile.

Critical Accounting Policies and Estimates, page 19

Stock Based Compensation, page 19
 3. We reference the revisions made in response to prior comment 4. Since your
common stock is not currently listed on an exchange there appears to be judgment
in determining the fair value of the u nderlying stock when valuing stock options
and warrants.  As such, please revise to  discuss how you determine the fair value
of common stock when using the Black-Sc holes-Merton option-pr icing model.
 4. In addition, please revise th is section to discuss how  you determine measurement
dates for non-employee stock transac tions and the judgments involved in
assessing probability when  accounting for equity inst ruments with performance
and service conditions.  Refer to SEC Release No. 33-8040, Cautionary Advice
Regarding Disclosure about Crit ical Accounting Policies.
 Recent Accounting Developments, page 21

 5. You disclose that you believe FSP APB N o. 14-1 will apply to your contingent
convertible senior notes.   Accordingly, tell us how you concluded that the
adoption of the FSP will “not have a materi al impact to [your] financial position,
results of operations and liquidity.”
 Results of Operations - Twelve Months Ended December 31, 2008 and 2007, page 21

 6. We note your explanation that general and administrative expenses increased in-
part due to legal fees in connection with your October 2008 financing.  To the
extent legal fees incurred were directly  attributable to th e October 2008 financing,
clarify for us how your accounting consider s the guidance from SAB Topic 5A.
 Liquidity and Capital Resources, page 22

 7. Regarding your response to prior comment 9:

• The second paragraph under this caption states that the table that follows
summarizes your currently known capita l requirements and outstanding
obligations.  However, your response to  prior comment 9 im plies that such
table does not summarize your outst anding debt and other contractual
obligations, such as those menti oned on page 25.  If your “Capital
Requirements” table does not include a ll of your outstanding obligations, then
please revise the second paragraph to re move any implication to the contrary

Kevin R. Davidson
BioDrain Medical, Inc.
June 5, 2009 Page 3
and to tell investors where in your document they can find information
relating to your other ou tstanding obligations;
• Refer to the second full paragraph on page 24.  Expand to clarify why your
“ability to raise this new capital is in substantial doubt.”  For example, does
your early stage position and history of losses make it more difficult to raise
capital?; and
• Tell us the reasons for your deletions to  the fourth paragraph on page 24.  Do
the holders of your debt no longer have a secured interest in your assets or
have they agreed to no t seize your assets?
 Commitments and Contingencies, page 25

 8. We refer to the responses to prior comments 7 and 8.  Please expand the
disclosures about the reduc tion of accrued salaries on pages 26 and F-18 to
address the following:

• Clarify how the amounts waived in 2007 sum to the $346,714 recorded as a
capital contribution in the statem ent of stockholders’ deficit.
• Clarify that the reduction of accrued pa yroll liabilities wa s recorded as a
capital contribution and disclose the rationale in GAAP on which the
accounting is based.
• Disclose the periods that the servic es were rendered.  We see from your
response to the prior comment that $244,000 of accrued salaries was earned in 2006.
 Other Securities For Issuance . . ., page 30

  9. We note from the disclosure added here in  response to prior comment 10 that Mr.
Dauwalter received “an additional 20,000 shares, for a total of 30,000 vested
shares” as a result of “FDA application and final clearance.”  Please tell us which provision of exhibits 10.37 or  10.38 provide that the opti ons would vest according
to that schedule.  It appears from thos e exhibits that Mr. Dauwalter was only
entitled to receive 10,000 shares upon execution of the agreement and an
additional 10,000 shares upon approval by the FDA.

Industry and Market Analysis, page 32

10. We note your response to prior comment 13.  We reissue that comment because
you have not yet provided us with copies  of the Outpatient Surgery Magazine
article cited in your disclosure.

Kevin R. Davidson
BioDrain Medical, Inc.
June 5, 2009 Page 4  Corporate Strategy, page 40

 11. We note your revisions in response to pr ior comment 15.  However, it continues
to be unclear how your management’s “international manufacturing experience” will allow you to “develop global purchasing and/or manufacturing sources for key sub-assemblies.”  It is also unclear  how these “key sub-assemblies” will
“drive a significant per unit cost reduction.”  Therefore, we reissue the comment.
If you mean that you may seek to manuf acture your products outside the United
States because it would be cheaper to do so, then please revise for clarity.
 Handling Costs, page 44

 12. We reissue prior comment 17 because alt hough your response states that “[t]his
section has been updated,” it app ears no revisions were made.
 Engineering and Manufacturing, page 47

 13. Your response to prior comment 18 and di sclosure on page 48 indicates that you
have no minimum purchase obligation with respect to the cleaning fluid.  Please
reconcile those statements with the term s of exhibit 10.47, including the last table
in exhibit B and sect ions 2.1(i) and 6.3.

14. We note that you intend to submit a request for confidential treatment with regard
to exhibit 10.47, and deleted information on pa ge 2 of exhibit B.  It appears that
you also deleted the pricing information from  page 1 of exhibit B, but did not note
the deletion.  Please refile the exhibit and ensure that all deleted information is
appropriately marked.

Directors, Executive Officers, Promoters and Control Persons, page 53

15. Please expand your response to prior comment 21 to clarify how you reached your conclusions regarding Mr. Shuler’s l ack of policy making functions and that
he is not an employee, given your respons e to prior comment 19 that “Mr. Shuler
has been appointed Corporate Secretary.”
 Summary Compensation Table, page 56

 16.  We note your response to prior comment 22:

• Please disclose your response to fi rst bullet of prior comment 22;
• We reissue the third bullet of prio r comment 22, which sought disclosure
regarding the reasons for awarding Mr. Davidson a $25,000 bonus, not merely
a response.  When providing such disclo sure, please ensure you fully explain
the basis for the bonus in light of the liq uidity issues you disclose.  In this

Kevin R. Davidson
BioDrain Medical, Inc.
June 5, 2009 Page 5
regard, we note your response that the bonus was “merit based,” which does not appear to adequately explain why the bonus was awarded.

Outstanding Equity Awards . . ., page 58

17. We note your response to prior comment 23.  If the issuance  of the 80,000 and
160,000 options to Messrs. Davidson and Rice is contingent on raising $3 million,
then please revise note 1 to your table to  remove the implication that “vesting” is
contingent on raising $3 million.
 Selling Security Holders, page 64

 18. Please tell us why your disclosure on page 71 includes shares held by David Dauwalter in determining James Dauwalter’ s beneficial ownership, but your table
here appears to exclude those shares.  Li kewise, please tell us  why your disclosure
here and on page 71 treats differently shares owned by the family members of Mr. Chad Ruwe and Mr. James Dauwalter.
 Security Ownership . . ., page 70

 19. We note the reduced numbers in the ta ble on page 71 for Messrs. Patel and
Richardson.  Those numbers do not equal th e totals of the shares disclosed in
notes 12 and 13.  Please revise or advise.

Warrants and Convertible Debt, page 73

 20. Refer to the first paragraph following the table on page 74.  Given your disclosure
there and on page F-21, it appears that  the penalties and additional shares you
mention are already required to be paid and issued by you.  If so, please revise to
state so directly, includi ng that amount that you are obligated to pay as of the
most recent practicable date.  Also note your obligations under Items 403, 404 and 507 of Regulation S-K.

Legal Matters and Interests of Named Experts, page 79

21. Regarding your response to prior comment 31:

• Disclose the $150,000 debt you owe to the law firm; and
• Tell us why you deleted disclosure from this section that the notes held by
members of the law firm are in defau lt and regarding pena lty provisions that
apply if this registration statement does not become effective within a
particular time frame.  If that “p articular time frame” has passed, as is
indicated by your disclosure on page 74 and F-21, then include disclosure
regarding the amount of penalties that has accrued.

Kevin R. Davidson
BioDrain Medical, Inc.
June 5, 2009 Page 6  Financial Statements, page F-1

 22. Please update the financial statements wh en required by Rule 8-08 of Regulation
S-X.
 23. We see that the balance sheet and stat ements of operations, cash flows and
stockholders’ deficit have been adjusted as of and for the year ended December
31, 2008.  Please revise to labe l those financial statements  as “restated” and to
include the disclosures required by paragraph 26 of SFAS 154.
 Report of Independent Registered Public Accounting Firm, page F-2

 24. We note that you have restated your financial statements.  Please have your
auditors revise the audit opinion to reference the fact that the financial statements have been restated.  In addition, please tell us how your auditors considered whether they should update the date of the report as a resu lt of the restatements.
 Note 1.  Product Development, page F-9

 25. If what you refer to as product developmen t costs is research and development as
defined in SFAS 2, please revise to clar ify.  If it is not, please disclose the
amounts of research and development e xpense for each period as required by
paragraph 13 of SFAS 2.
 Note 3.  Stockholders’ Deficit, Stoc k Options and Warrants, page F-10

 Valuation and accounting for optio ns and warrants, page F-12

 26. Please revise to provide the disclosu res required by paragraphs A240(c) and
A240(d) of SFAS 123-R.  Please also disclose the total compensation cost for share-based payment arrangements r ecognized in income, as required by
paragraph A240(g)(1) of SFAS 123-R.

Warrants, page F-14

 27. While we acknowledge your response to prior comment 46, it continues to be
unclear how the paragraphs under the caption “Warrants” address the full 5.7
million warrants granted in 2008 as reflected in the table on page F-12.  Please revise to include disclosure  about all warrants issued dur ing 2008 or show us that
the discussion is complete.

Kevin R. Davidson
BioDrain Medical, Inc.
June 5, 2009 Page 7  Note 11.  Restatement of 2007, page F-22

 28. Please revise to provide all of the disc losures required by paragraph 26 of SFAS
154. The expanded disclosure should provide the originally repor ted balance, the
impact of each
 individual restatement adjustment and the “as restated” balance for
each restated financial statement caption.
 29. Please also revise to provide a complete na rrative description of  (1) the nature of,
(2) the reasons for and (3) the quantitative impact of each
 restatement adjustment.
The expanded disclosure should also clarify why management believes the
original accounting was incorrect and clar ify the basis in GAAP for the revised
accounting.
 30. In addition, please revise to disclose th e impact of the restatements on earnings
per share for all periods presented.  Refer to paragraph 26 of SFAS 154.
 Exhibit 23.1

31. Please include a currently dated and si gned consent from your independent
auditors prior to requ esting effectiveness.
  32. The consent included as Exhibit 23.1 refers  to an audit repor t dated May 14, 2009.
Please reconcile that statemen t with the date of the current audit report included in
your registration statement,  which is April 3, 2009.

*  *  *  *  *  *  *

As appropriate, please amend your regist ration statement in response to these
comments.  You may wish to provide us with marked copies of the amendment to expedite our review.  Please furnish a cove r letter with your amendment that keys your
responses to our comments and provides any requested information.  Detailed cover
letters greatly facilitate our review.  Please understand that we may have additional comments after reviewing your amendmen t and responses to our comments.
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filing to be certain that the filing includes all in formation required under
the Securities Act of 1933 and that they have  provided all information investors require
for an informed investment decision.  Since the company and its management are in possession of all facts relating to a company’ s disclosure, they are responsible for the
accuracy and adequacy of the disclosures they have made.

Kevin R. Davidson
BioDrain Medical, Inc. June 5, 2009 Page 8   In addition, please be advi sed that the Division of En forcement has access to all
information you provide to the staff of the Di vision of Corporation Finance in connection
with our review of your filing or in response to our comments on your filing.
We will consider a written request for acceleration of the effective date of the
registration statement as conf irmation of the fact that t hose requesting acceleration are
aware of their respective re sponsibilities under the S ecurities Act of 1933 and the
Securities Exchange Act of 1934 as they rela te to the proposed public offering of the
securities specified in the above registration statement.  We will act  on the request and,
pursuant to delegated authority, grant acce leration of the effective date.
We direct your attention to Rules 46 0 and 461 regarding requesting acceleration
of a registration statement.  Please allow ad equate time after the filing of any amendment
fo

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

       DIVISION OF
CORPORATION FINANCE
     Mail Stop 3030
        April 17, 2009
 Kevin R. Davidson Chief Executive Officer 2060 Centre Pointe Boulevard, Suite 7 Mendota Heights, Minnesota  55120
Re: BioDrain Medical, Inc.
Amendment No. 3 to Registrati on Statement on Form S-1
Filed April 6, 2009
  File No. 333-155299

Dear Mr. Davidson:

We have reviewed your filing and have the following comments.  Where
indicated, we think you should re vise your document in response to these comments.  If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary.  Please be as deta iled as necessary in your explanation.  In
some of our comments, we may ask you to provi de us with information so we may better
understand your disclosure.  After reviewing th is information, we may raise additional
comments.
We welcome any questions you may have  about our comments or any other
aspect of our review.  Feel fr ee to call us at the telephone numbe rs listed at the end of this
letter.
Prospectus Summary, page 1

The Offering, page 1

1. Tell us how the numbers in the bullet poi nts account for the options and warrants
granted to Ms. Doerfert pursuant to her employment agreement.

Because we are a development stage company…, page 3

2. Either expand the caption to also highli ght the fact that your independent audit
firm has issued a going concern opinion, or relocate that disclosure under a
separately titled caption.

Kevin R. Davidson
BioDrain Medical, Inc.
April 17, 2009 Page 2  Management’s Discussion and Analysis, page 19

3. We see that you obtained FDA final clea rance for your product on April 1, 2009.
Please revise your disclosure to stat e when you expect to begin generating
revenues from the sale of your product.

Critical Accounting Policies and Estimates, page 20
 4. We reference prior comment 9.  Please revise the discussi on of stock-based
compensation to describe how you determin ed each of the individual assumptions
used in the Black-Scholes-Merton option- pricing model.  In addition, you should
discuss how you determine measurement dates for non-employee stock transactions and the judgments involved in assessing probability when accounting
for equity instruments with performance and service conditions.

Results of Operations, page 22

5. We see that you discuss “general and administrative expense”, “operations
expense,” and “sales and marketing expe nse,” which do not reconcile to the line
items on the statement of operations of “operating expenses” and “product
development expenses.” Please revise to  reconcile your MD&A discussion with
the line items presented on th e statement of operations.
 General and Administrati ve expense, page 22

 6. We reference the disclosure that th e increase in stock based compensation
expense resulted from using the “grant date  fair value method.”  Clarify if this
method is different from that used in prior years.  If not, please revise to provide a
substantive discussion of the underlying r easons for increased expense for stock-
based compensation, such as a descri ption of the underlying arrangements
responsible for the increased expense in 2008.
 7. Please reference the response to prior co mment 10.   To further assist us in
understanding the accounting applied in the reduction of accrued salaries, please
respond to the following:

• Please tell us how much of the $346,000 was accrued as of December 31,
2006.  That is, clarify for us the dollar amount accrued in prior years that was
later credited to expense in 2007.
• In the third bullet you indicate that you accounted for the reduction of accrued
shareholder salaries as an early extin guishment of debt under APB 26.  Tell us
why you believe, as stated in your response, that the forgiveness of amounts due to your shareholders for services previously rendered and accrued for is

Kevin R. Davidson
BioDrain Medical, Inc.
April 17, 2009 Page 3
not a capital contribution to your business under footnote 1 of APB 26.  That is, please explain the basis in GAAP for your view that the shareholders did not make a contribution to capital upon agreeing to waive the accrued amounts due them.
• In the fourth bullet you indi cate that the equity instru ments to be issued are
compensation for past services.  Accord ingly, tell us why issuance of those
instruments is linked to future financ ing, including why issuance of those
instruments is dependent on your liquidit y.  Also, tell us the period when the
underlying services were rendered.
• We refer to the fourth and sixth bulle ts.  You indicate that the compensation
expense for the equity instruments is being amortized over the derived service period.  Please tell us that period and tell us how you determined that service period under the guidance from SFAS 123(R).
• As a related matter, if as indicated in the fourth bullet, the equity instruments are for past services, please tell us why the sixth bullet indicates that the value
assigned to the equity instruments is be ing amortized over some future period.
That is, if the equity instruments are for past services, please tell us why the
full fair value was not expens ed at the date of the agreements.  In that regard,
as previously requested please fully e xplain to us in a written response how
the accounting for these instruments is consistent with SFAS 123(R).
 8. We refer to your response to prior comment 10 and to the disclosure about the
accrued salary reduction on pages 27 and F-12.

• Please disclose, as indicated in your re sponse, that accrued  payroll after the
reduction recorded in November 2007 was $115,000 and disclose the financial
caption statement where the accrued amount is presented.
• Please disclose, as indicated in the four th bullet of your resp onse, that the cash
amounts and equity instruments to be issu ed are for past services rendered by
individuals and disclose th e periods when the services were rendered.  Please
clarify, as indicated in y our response, that the cash and equity payments are
not compensation for obtaining the future funding on which payment is contingent.
• As your response indicates that the equ ity instruments were earned for prior
services, please disclose why issuance of those instruments is contingent on future funding.
• Add disclosure that explains how the equity instruments are being accounted
for and that provides sufficient cont ext to clarify how the accounting is
appropriate under SFAS 123(R).

Kevin R. Davidson
BioDrain Medical, Inc.
April 17, 2009 Page 4  Liquidity and Capital Resources, page 23

 9. We note your response to prior comment 13:

• We reissue the first bullet given the c ontinued inconsistenc ies regarding your
outstanding debt obligations on pages 23, 26 and 27.  As one example, you
disclose on page 23 that you owe Andcor  $50,000 but disclose on page 26 that
the amount of such debt is $10,000; and
• Disclose the nature of the “other operating expenses” mentioned in the table
on page 23.  Also, your response implies that you believe such expenses are
“insignificant.”  If so, tell us how you reached that conclusion, given that such
expenses comprise almost half of your known capital requirements.

Stock and Stock Options, page 31

 10. We note the disclosure on page 32 regardi ng the vesting of options granted to Mr.
Dauwalter.  Given the terms of such vesting as noted in exhibit 10.38 and your
disclosures regarding FDA cl earance on April 1, 2009, it a ppears that a portion of
those options have already veste d.  Please revise or advise.
 Description of Business, page 34

Overview, page 34

11. We note your response to prior comment 4.  If you will register a class of your
securities under Section 12 of the Exchange Act concurrently with the
effectiveness of this registration statement, then please revise to state so directly.
The third paragraph under this caption im plies that you will be subject to the
reporting requirements of the Exchange Act solely because this registration
statement will become effective.
 12. We reissue prior comment 15.  Contrary to  your response, you have not disclosed
on page 32 the exercise prices with respect to the June 16 and August 11, 2008
transactions.

Industry and Market Analysis, page 35

13. Regarding your response to prior comment 18:

• Please furnish the staff with the Frost & Sullivan research report that contains
the $120 million estimate that you reference in the penultimate paragraph on
page 35; and

Kevin R. Davidson
BioDrain Medical, Inc.
April 17, 2009 Page 5
• We reissue prior comment 18 with resp ect to the study cited in the first
paragraph on page 48 and Outpatient Surg ery Magazine article cite in the first
paragraph on page 50.
 14. Expand the table on page 38 to include the comparative information for the
Cardinal disposal system.

Corporate Strategy, page 43

 15. Please clarify the meaning of the pe nultimate bullet point on page 44.  The
meaning of that sentence is unclear.
 Drainage Systems, page 45

 16. Please revise the first paragraph on pa ge 46.  It appears words are missing.
 Handling Costs, page 47

 17. We note your reliance on the research articl e referenced in the last paragraph.  We
also note that the article covers a total of 31 exposures, the majority of which are
percutaneous exposures from needle sticks  or cuts from sharp objects which are
more severe and more costly for hospitals to  address.  We also note that the article
concludes that the overall mean cost was $1,687 per exposure, including the more
serious percutaneous exposures.  Please cl arify this for investors and revise your
cost estimate accordingly for non-percutaneous exposures.
 Engineering and Manufacturing, page 50

 18. Please reconcile your response to prior co mment 23 with your disclosure in this
section, where you indicate that you “have not yet entered into agreements with
any suppliers for there products.”  If you have entered “an exclusive licensing
agreement with Oculus Innovative Resear ch,” as mentioned in your response,
ensure that your disclosu re describes the material terms of that agreement
including, among other things, the du ration and any minimum purchase
requirements.
 Employees, page 57

   19. Reconcile your disclosure here with your disclosure on page 8.  It appears your
disclosure here regarding the number of your employees does not include Mr.
Shuler.

Kevin R. Davidson
BioDrain Medical, Inc.
April 17, 2009 Page 6  Directors, Executive Officers, Promotors and Control Persons, page 58

 20. Please tell us why you deleted information regarding Mr. Gerald Rice from this
section.  We note that according to the signatures page, he is a member of your
board of directors.
 21. Given your disclosure on page 8, please disclose the information required by Item
401 of Regulation S-K with respect to Mr. Alan Shuler.  Please also file as an
exhibit your employment ag reement with Mr. Shuler.

Summary Compensation Table, page 62

 22. We note your response to prior comment 31:

• Your disclosure in the notes to the summary compensation table continues to
be inconsistent with your disclosure on pages 64-65 and response to the third
bullet of prior comment 34 regarding the amounts Messrs. Davidson and Rice
were entitled to receive pursuant to  their employment agreements.  For
example, your response to prior comme nt 34 states that Mr. Davidson was
entitled to receive $185,000 under his em ployment agreement; however, your
disclosure here states he was entit led to $160,000 and your disclosure on page
64 states he was entitled to receiv e $170,000.  Similarly, you disclose here
that in 2008, Mr. Rice was entitled to receive $114,250 but disclose on page 64 that he was entitled to r eceive $118,500.  Please reconcile;
• As a result of the inconsistencies noted above, the numbers in the notes
following this table are difficult to foll ow.  For example, you state that Mr.
Davidson was entitled to receive $160,000 in 2008.  You then state that he was paid $126,650, including a bonus, a nd waived payment of $58,250.  The
amounts he was paid and waived do not appear to add to $160,000.  Similarly,
you state that Mr. Davidson was en titled to receive $150,000 in 2007.  You
then state that he was paid $59,375 and waived $70,000 in compensation for
2007 and prior years.  As a result, it appears the amounts he was paid and waived in 2007 do not add to $150,000.   Please reconcile; and
• Disclose the reasons for awardi ng Mr. Davidson a $25,000 bonus in 2008,
given your disclosures regarding shortage of  cash and liquidity issues.

Outstanding Equity Awards at Fiscal Year End, page 63

23. Your response to prior comment 78 indicates that you will issue the 80,000 and
160,000 options to Messrs. Davidson and Rice, respectively, when you have
raised an additional $3 million.  Your tabl e here, including note 1, indicates that
you have issued those options and that ve sting, rather than issuance, of those
options is contingent on raising an additional $3 million.  Please reconcile.

Kevin R. Davidson
BioDrain Medical, Inc.
April 17, 2009 Page 7  Employment Agreements . . ., page 64

 24. Refer to the third full paragraph on page  67 regarding the vesting of options
granted to Mr. Ruwe.  Given your disclosu re that you have requested and received
FDA clearance, it appears that a portion of those options have vested and are now
exercisable.  If so, please revise to disclose that fa ct.  Also ensure that your
disclosure in the tables appearing on pages 71-73 and 77 account for any changes
in the number of vested and exer cisable options held by Mr. Ruwe.
 25. Discuss the material terms of Ms. Doerfert’s employment agreement.
 Certain Relationships and Re lated Transactions, page 70

 26. Regarding your reference to a verbal ag reement in response 32, please refer to
Regulation S-K Compliance and Disclo sure Interpretation Question 146.04
available on our web site at http://www.sec.gov/divisions /corpfin/guidance/regs-
kinterp.htm .
 Selling Security Holders, page 70

  27. We note your response to prior comment 38.  However, the first bullet on page 71
continues to refer to shares underlying  a “convertible debenture” while notes 11-
17 and 24 refer to shares underlying a “conve rtible promissory note.”  You also
refer on page 79 to outstanding convertible notes.  Please reconcile.
 Security Ownership of Certain Benefi cial Owners and Management, page 76

28. Please disclose your response to prior co mment 39.  Also revise your disclosure
on page 34 under the caption “Private Placement Financing” and on page 79
where you state that the warrants “are immediately exercisable.”

Common Stock, page 78

29. Please provide current disclosure.  We note the references in the first paragraph to
the number of shares outstanding and number  of shareholders as of November 1,
2008.

Warrants and Convertible Notes, page 79
 30. Regarding your response to prior comment 41:

• Your response to prior comment 61 in our letter dated January 29, 2009 stated
that “the convertible note financing that was closed in July 2007 was
considered a bridge loan to allow su fficient time to arrange a subsequent

Kevin R. Davidson
BioDrain Medical, Inc.
April 17, 2009 Page 8
financing which was finalized in Octobe r 2008.”  If so, please disclose that
fact.  Your current disclosure is un clear regarding how the convertible note
financing relates to the October 2008 financing; and
• Disclose the identities of the seven br idge loan holders mentioned in your
response to prior comment 41.  That co mment requested disclosure of those
identities, not simply identifyi ng them in your response letter.
 Legal Matters and Interests of Named Experts, page 85

 31. We note your response to prior comment 42.  Given your response to prior
comment 41 regarding the identities of th e bridge loan holders , it is unclear how
you co

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

       DIVISION OF
CORPORATION FINANCE
     Mail Stop 3030
        February 24, 2009
 Kevin R. Davidson Chief Executive Officer 2060 Centre Pointe Boulevard, Suite 7 Mendota Heights, Minnesota  55120
Re: BioDrain Medical, Inc.
Amendment No. 2 to Registrati on Statement on Form S-1
Filed February 12, 2009
  File No. 333-155299

Dear Mr. Davidson:

We have reviewed your filing and have the following comments.  Where
indicated, we think you should re vise your document in response to these comments.  If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary.  Please be as deta iled as necessary in your explanation.  In
some of our comments, we may ask you to provi de us with information so we may better
understand your disclosure.  After reviewing th is information, we may raise additional
comments.
We welcome any questions you may have  about our comments or any other
aspect of our review.  Feel fr ee to call us at the telephone numbe rs listed at the end of this
letter.
Fee Table

1. We will continue to evaluate your re sponse to prior comment one after you
respond to the comments in this letter.
 2. Please tell us how your fee table account s for the disclosure you added in
response to prior comment 3.  We note, for example, the multiple references to
“N/A” in the column captioned “Proposed maximum offering price per share.”

Prospectus Cover Page

3. We will continue to evaluate your respons e to prior comment 2 after the warrants
underlying the convertible notes have been issued.

Kevin R. Davidson
BioDrain Medical, Inc.
February 24, 2009 Page 2   Prospectus Summary, page 1

4. Please disclose the second sentence of  your response to prior comment 7.

Risk Factors, page 3
 Because we are a development stage company . . ., page 3

   5. Please tell us the reasons for the deletions to this risk factor.  Does management
no longer believe the factors described in th is risk factor rais e substantial doubt
about your ability to continue as a going concern?  If so, explain why and what
circumstances have changed, particularly  given your stage of development and
lack of revenues.
 If we do not succeed . . ., page 7

 6. We note your response to prior comment 6:

• Please revise the last paragraph to clarify how FDA approval may eliminate
your “prospectus”;
• Clarify how the restructuring changes pose a risk to potential investors in this
offering.  In this regard, please reconc ile your response and disclosure on page
54 regarding whether investors will ow n a public company shell after the
restructuring changes are implemented;
• Expand to disclose whether the “Investo rs” or your affiliates are engaged in
any discussions or negotiations with  respect to a reverse merger; and
• Clarify the meaning of the last senten ce in this risk factor.  Your other
disclosure indicates that your assets and operations will be transferred to
Privco at the time of the restructuring.

We are dependent for our success . . ., page 8

 7. We note the disclosure that you have entered into employment agreements with
all members of your senior management t eam, including Ms. Doerfert.  Please file
your agreement with her as an exhibit.
 Market Price of and Dividends . . ., page 16

 8. We reissue prior comment 10, given that it appears your disclosure here and page
28 continue to disclose different  numbers of outstanding warrants.

Kevin R. Davidson
BioDrain Medical, Inc.
February 24, 2009 Page 3  Critical Accounting Policies and Estimates, page 21

9. We re-issue prior comment 12.  Please re vise to provide a discussion of your
critical accounting policies and estimates.   This discussion should present your
analysis of the uncertaintie s involved in applying an accounting principle at a
given time and the variability that is  reasonably likely to result from its
application over time. You should addr ess specifically why your accounting
estimates and assumptions bear the ri sk of change.  Refer to FR-72.

In that regard, it would appear that  accounting for stock-based compensation
under SFAS 123(R), EITF 96-18 and related guidance is particularly complex and
subjective.  For instance: (1) determination of fair  value generally involves
subjective assumptions, such as those used for Black-Scholes purposes, (2)
determination of the measurement date is complex, especially for non-employee transactions and (3) the acc ounting for equity instrume nts with performance and
service conditions involves subjectiv e judgments about probability.
 While we see the changes in response to the prior comment, the revisions do not address relevant accounting complexities and do provide the required disclosure.

Nine Months Ended September 30, 2008 and 2007, page 21

General and Administrative, page 22

10. We refer to your response to prior co mment 15 from our letter dated January 29,
2009 and prior comment 27 from our letter  dated December 10, 2008.   The basis
in GAAP applied in accounting for the reduc tion of accrued salaries continues to
be unclear and we have continuing con cerns that the accounting may not comply
with GAAP.  Please respond to the following:
• In a written response tell us the da te the accrued salary reduction was
recorded.  Also provide us a schedul e that shows the amounts accrued for each
individual before and after the $346,000 adjustment.
• In some instances, such as on page 22, you indicate that th e accrued salaries
were “deferred.”  In other instances, you indicate that th e accrued salaries
were “waived.”  Please tell us and clarif y whether the salaries were deferred
or waived.
• It appears that the accrued salaries were  for services rendered by your officers
who also appear to be shareholders.  Accordingly, to the extent accrued
salaries were waived, it is  not clear why there is not  a contribution to capital
from these individuals.  As well, it is not clear how the accounting considers

Kevin R. Davidson
BioDrain Medical, Inc.
February 24, 2009 Page 4
the guidance from SAB Topic 1.B.1, which requires that the financial statements include all cost s of doing business.  Please advise in a complete
written response.  Also, cite the basis in GAAP on which you have relied.
• Tell us whether the cash bonuses and equity instruments to be paid upon
raising $3 million are intended to be compensation for raising the $3 million
or payment for the services rendered pr ior to the reduction of the accrual.
• Tell us why the accrual was not adjusted to the fair value of the agreed upon
future cash and equity payments in the 2007 financial statements.  Tell us why
the accounting is contingent on the futu re funding.  Provide us a complete
written response that explai ns your view and that expl ains how that view is
consistent with GAAP.  Cite the literature on which you rely.
• Tell us how your accounting for the con tingent stock options considers the
guidance from paragraphs 47, 48 and Appendix A of SFAS 123(R).  Your
written response should fully explain how  you applied the guidance applicable
to stock options with a performance condition.
11. As a related matter, while we see the di sclosure about the accounting applied in
the reversal of accrued salaries under Ge neral and Administrative (page 22), the
paragraph does not appear to make understandable accounting disclosure.  We may have further comment on your disclo sure upon resolution of the related
accounting issue.
12. We note your response to prior comment 13.  If the full salary rate has been
accrued as an expense and not actually paid  in a timely manner or at all, as
suggested by your response, then revi se your disclosure to eliminate any
implication that you “paid” salaries.

Liquidity and Capital Resources, page 22

13. Regarding your response to prior comment 16:

• We reissue the first bullet, given the continued inconsistencies on pages 23, 25
and 26 regarding outstanding debt payments you are obligated to make;
• Expand your response to the third bulle t to disclose th e total amount of
accrued payroll expense you have accrued;
• Expand your response to the fourth bullet to clarify whether you have
sufficient cash to satisfy a formal payment demand.  If you do not, disclose what rights the holders of debt have; fo r example, may they seize your assets?;
and
• We reissue the eighth bullet, which requested disclosure of the nature of the
“other operating expenses” noted on page 23.

Kevin R. Davidson
BioDrain Medical, Inc.
February 24, 2009 Page 5  Stock Options and Warrants, page 27

   14. We note your response to prior comment 47 and the second paragraph below the
table on page 29.  Please explain th e purpose and significance of the 1,920,000
determination mentioned.  Also, given your  disclosure in this section, including
the table on page 30, explain why the reverse splits only impacted the securities held by your founders.

Description of Business, page 34

15. We reissue prior comment 21.  We note, for example, the June 16 and August 11,
2008 transactions mentioned on page 31 do not re fer to an exercise price.

Overview, page 34

16. Please reconcile your response to prior comment 22 with your disclosure here
regarding the identity  of your founders.

17. Revise the first paragraph to disclose the products for which you have obtained
patent rights.
 Industry and Market Analysis, page 35

18. We note your response to prior comment 5.  However, your disclosure in this
section and on page 48 continues to cite to  data from third-part y sources.  Please
provide us copies of that data, marki ng the relevant sec tions to support the
disclosure.
 The Fluid Management System (“FMS”), page 38

19. Please reconcile your reference to your “proprietary” cleaning fluid in the fourth bullet on page 40 and on page 53 with your response to prior comment 28.

Patents and Intellectual Properties, page 41

20. Please expand the second paragraph on page  43 to disclose the first sentence of
your response to prior comment 28.

21. Please reconcile your disclosure added to the first paragraph of this section on
page 41 with your disclosure on page 38, which notes that the product made by
MD Technologies also has unlimited fluid capacity.

Kevin R. Davidson
BioDrain Medical, Inc.
February 24, 2009 Page 6  Current Competition, Technology, and Costs, page 46

  22. Please tell us where you have disclosed the third and last sentences in your
response to prior comment 33.
 Engineering and Manufacturing, page 51

 23. We note the disclosure that  your disposable cleaning kit will be sourced through
alternative suppliers.  Please reconcile th at disclosure with your disclosure on
page 43, which indicates that you will ha ve only one supplier of that product.
 Government Regulation, page 51

24. Please provide current disclosure.  We not e, for example, the disclosures on page
52 that final documentation of testing results is scheduled for January 31, 2009
and that you expect successful testing.  If previously disclosed plans have
changed, disclose the material r easons for the change or delay.
 25. We note your response to prior comment 37.  Your disclosure on pages 7 and 54
continue to state that you entered into the restructuring agreement in June 2007;
however, exhibit 10.42 states that the date  of such agreement was June 9, 2008.
Therefore, we reissue prior comment 37.
  26. We note your response to prior comment 38:

• It continues to appear that  investors who acquire the sh ares to be sold pursuant
to this registration statement will not be able to cause the restructuring
changes mentioned in your disclosure.  Pl ease revise to disclose this fact, if
true;
• Your first paragraph continues to state that the “Investors” will maintain their
shares of your common stock.  Clarify how this will occur, as previously
requested, given that those shares are registered here for resale;
• Clarify how the “Investors” will have  the same percentage ownership of
Privco that they had in the company before the transaction, given that the
“Investors” shares are registered here for resale.  This arrangement appears to
result in the “Investors” ow ning indirectly a higher percentage of Privco than
they would appear to be entitled, give n that the “Investors” shares may be
sold.  As such, it also appears that the percentage owne rship that potential
purchasers of your securities may have will not be based on the number of
shares they actually hold;
• Disclose your response to the third bullet;
• We reissue the fourth and sixth bullets  of prior comment 38, which requested
expanded disclosure regarding the identity of the “Company shareholders”

Kevin R. Davidson
BioDrain Medical, Inc.
February 24, 2009 Page 7
and whether a reverse merger or si milar transaction involving you was
currently being negotiated or considered;
• It appears from your response to the fifth bullet that you are relying on no
authority for your conclusion that share holder approval is not required for the
asset transfer to Privco.  Please confir m that understanding.  Also tell us how
you concluded that Privco will be a “wholly-owned” subsidiary, given that the
“Founders” will also own Privco shares; and
• If only the “[PPM] investors” will receive  the proceeds of a sale or liquidation
of Privco, as noted in your response to th e last bullet, then disclose that fact,
and highlight that risk to  potential investors.
 27. We note your responses to prior comments 40 and 41:

• You state that the restructuring agreem ent was not part of the subscription
agreement for your recent financi ng and were only a “unilateral
acknowledgement” by the “Founders.” You th en state that no investor in the
financing executed the agreement and that the “PPM” was modified.  Please tell us how investors in that financing agreed to the terms of the restructuring.  Given your disclosure that  the restructuring was designed to induce these
investors, it appears that they would have actually ag reed to the terms of the
restructuring.  Also tell us why if the “PPM” was modified per your response,
those modifications are not reflected in exhibit 10.31.
• Given your deletions in response to pr ior comment 40, it is unclear how the
“June 2007” restructuring agreement is  “in connection w ith” your October
2008 financing.  Please revise to cl arify how those agreements relate.

Directors, Executive Officers, . . ., page 59

28. We note your response to prior comment 42.  Given your disclosure on page 40
regarding the qualifications and experience  of the FDA consultants and advisors
you have retained, it is unclear why you should not provide di sclosure required by
Regulation S-K Item 401 as to them .  See Item 401(c) and Rule 408.

29. Given your disclosure on page 60, please re vise to include Ms. Doerfert in your
table here.

Medical Advisory Board, page 61

30. We reissue the third bullet of prior co mment 43, because it is unclear where you
provided the disclosure requested by that bullet.

Summary Compensation Table, page 63

31. We note your response to prior comment 44:

Kevin R. Davidson
BioDrain Medical, Inc.
February 24, 2009 Page 8
• Please reconcile your disclosures in the notes to the summary compensation
table and on pages 64 and 65 regard ing the amounts to which Messrs.
Davidson and Rice were entitled to receive pursuant to their employment
agreements and whether they have or ha ve not received options in satisfaction
of unpaid salaries.  Your table on page  29 also indicates that such options
have already been issued; and
• Clarify how the amounts of salary for 2008 that were unpaid will be
addressed; for example, did Messrs. Rice and Davidson agree to waive such
amounts?;

Certain Relationships and Re lated Transactions, page 70

32. We note your response to prior comment 48.  Please file as an exhibit the
agreement related to the deferral of consulting fees owed to Mr. Morawetz.

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

       DIVISION OF
CORPORATION FINANCE
     Mail Stop 3030
        January 29, 2009
 Kevin R. Davidson Chief Executive Officer 2060 Centre Pointe Boulevard, Suite 7 Mendota Heights, Minnesota  55120
Re: BioDrain Medical, Inc.
Amendment No. 1 to Registrati on Statement on Form S-1
Filed January 12, 2009
  File No. 333-155299

Dear Mr. Davidson:

We have reviewed your filing and have the following comments.  Where
indicated, we think you should re vise your document in response to these comments.  If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary.  Please be as deta iled as necessary in your explanation.  In
some of our comments, we may ask you to provi de us with information so we may better
understand your disclosure.  After reviewing th is information, we may raise additional
comments.
We welcome any questions you may have  about our comments or any other
aspect of our review.  Feel fr ee to call us at the telephone numbe rs listed at the end of this
letter.  Fee Table

   1. Please tell us, with a view toward disclo sure, how you concluded to register the
resale of 7,101,267 shares of common  stock and 4,689,290 shares underlying
warrants and that you have 8,180,831 shares ou tstanding.  It appears that adding
the numbers in the bullet points in your response to prior comment 1 does not result in the totals expressed prior to those bullet points, in  your fee table and
throughout your document.
 Prospectus Cover Page

   2. We will continue to evaluate your respons e to prior comment 4 after the warrants
underlying the convertible notes have been issued.

Kevin R. Davidson
BioDrain Medical, Inc.
January 29, 2009 Page 2   3. We note that you put in a price range.  Pr ior to effectivene ss, please state the
specific fixed price at which the securities  will be sold until they are trading on
the OTC Bulletin Board.
 Prospectus Summary, page 1

  4. If you have already received a United States patent for your product, as indicated
by your responses to prior comments 10 and 11, then please revise your second
paragraph here accordingly.

Risk Factors, page 3

We face intense competition . . ., page 5

5. We note your response to prior comment  12.  Because it appears you have not
provided us with the supplemental materi als we requested, we reissue the first
sentence of prior comment 12.  Also, pleas e reconcile your disclosure here and on
pages 38 and 46 regarding the market share currently held by Cardinal Health and
Stryker.
   If we do not succeed . . ., page 6

6. We note your responses to prior comments 6 and 15.

• Please clarify how the risk s disclosed in the last paragraph relate to the
restructuring agreement and how it may impact potential investors.  For
example, you refer here to the loss of management that could delay the
implementation of your business plan.  It is unclear how this poses a risk to
potential investors, given your disclo sure in the preceding paragraph, pages
53-54 and exhibit 10.42 that your operations  will cease and your assets will be
transferred to Privco.  Please revise; and
• Explain clearly, if true, that potential investors may own shares in a public
shell company if the FDA does not approve your product by the end of August 2009.
 Please also refer to comment 38 below.

We do not have a class of securi ties registered . . .,page 10

7. Regarding your response to prior comment 7:

Kevin R. Davidson
BioDrain Medical, Inc.
January 29, 2009 Page 3
• Revise your disclosure in the first para graph, which misstates the registrant’s
reporting obligations in the ev ent that it registers a cla ss of securities pursuant
to Section 12 of the Exchange Act;
• Clarify your reference in the caption and fi rst paragraph of this risk factor to
registering your securities on a “nationa l securities exchange.”  Do you mean
registering a class of your securi ties under the Exchange Act?;
• We reissue the second bullet in part  because that bullet requested an
explanation of the effects of the inapp licability of Section 16 of the Exchange
Act, not Section 26; and
• We note that you do not intend to register a class of your securities before this
registration statement is effective; however, your disclosure on page 68
indicates that you will register  a class of your securities at a later date.  Please
clarify when and whether you intend on re gistering a class of your securities
under the Exchange Act.  If you do not intend to so register, revise your
disclosure here and page 68 to remove  any implication to the contrary.

If our common stock is accepted for quotation . . ., page 11

8. We note your response to prior comment 17.  Rather than disclosing all listing
criteria applicable to the Nasdaq and NYSE markets, please revise to disclose the
listing criteria that you do not currently m eet, including the criteria noted in the
last sentence of this risk factor.
 Use of Proceeds, page 15

 9. Expand to disclose the warrant exercise prices for the warrants being registered.
 Market Price of and Dividends on the Registrant’s Common Equity…, page 17

 10. Reconcile the disclosure here with that on page 29 regarding outstanding
warrants.
 Critical Accounting Policies and Estimates, page 21

 11. Please clarify your reference on page 22 to TUV SUD being a regulatory body.  Is
their approval required before you can market and sell your products?  Or are they
a private company that perfor ms no regulatory oversight?

12. We re-issue prior comment 21.  Please re vise to provide a discussion of your
critical accounting policies and estimates.   This discussion should present your
analysis of the uncertaintie s involved in applying an accounting principle at a
given time or the variability that is reasonably likely to result from its application
over time. You should address specifically why your accounting estimates or

Kevin R. Davidson
BioDrain Medical, Inc.
January 29, 2009 Page 4
assumptions bear the risk of change. For example, it appears that there is
significant judgment in valuing stock options and warrants.  Refer to FR-72.   While we see the changes in response to the comment, the revisions do not
provide meaningful disclosure . Please further revise.

Results of Operations, page 22

Nine Months ended September 30, 2008 and 2007

13. Please reconcile your reference here to “paying” full annual salary rates with the
disclosure throughout your document that  you have accrued a salary expense,
which will be paid only when sufficient funds are available.
 Research and Development, page 22

14. We reference prior comment 24.  We see that you were notified in 2007 that you
would be billed $100,000 for product development work performed by a contractor in 2003 – 2007.   Please respond to the following:
• Tell us and disclose when you recorded the $100,000 accrual.
• Reconcile the disclosures in the “res earch and development” discussions on
pages 22 and 23 of MD&A.  From those di sclosures it is not clear whether the
$100,000 was accrued in 2006 or 2008.
• If the discussions on pages 22 and 23 ar e addressing different accruals, please
clarify the disclosure.  Please ensure  that you have provided a clear and
complete discussion of research and de velopment costs and the accruals for
those costs.
• Tell us why you did not make accruals for the work as that work was
performed.  In that regard, tell us why you believe there is no error in the
financial statements as it appears that  product development work performed in
prior years is expensed in a later year.

Years ended December 31, 2007 and 2006

 General and Administrative, page 22

15. We refer to your response to prior comm ent 27.  Please provide us and disclose a
clear basis in GAAP for the accounting app lied in the reducti on of the accrued
salaries.  While we see the revisions to the disclosure, those revisions do not
provide a clear and transparent discu ssion of the basis in GAAP for the
accounting.

Kevin R. Davidson
BioDrain Medical, Inc.
January 29, 2009 Page 5  Liquidity and Capital Resources, page 23

  16. We note your response to prior comment 29.  Please:

• Reconcile your disclosures on pages 23, 26 and 27 regarding the amount of
outstanding debt payments you are obligated to make;
• Expand the third paragraph on page 25 to clearly disclose the nature of the “risks to investors” from your early stag e position.  Also disc lose the “risk in
this process” mentioned in the penultimate paragraph on page 25.  For
example, do you anticipate providing an inducement similar to the restructuring agreement you provided the “Investors” in order to obtain funds through your October 2008 financing?;
• Expand the sixth paragraph on page 25 to  disclose the amount of funds from
your secondary financing that will be used to satisfy the obligations noted in
that paragraph;.
• Disclose the rights the holders of your debts have in the event they demanded
payment and you were unable to fulfill your obligations.  We note the
disclosure on page 25 that this woul d “create a liquidity issue,” which does
not appear to sufficiently describe th e results of a formal payment demand;
• Reconcile your disclosure in the first paragraph unde r this caption that you
expect research and development expenses  to increase with your disclosure in
the second paragraph on page 26 that there will be “nominal, if any, additional expenses incurred for the development of our product”;
• Expand to discuss in more detail “the progress we have made and the opportunities ahead of us” in raising additional funds.  Include in such
discussion the types of additiona l financing you are pursuing;
• Explain why you are “confident” that you will have the ability to raise $3
million during the first half of 2009, part icularly in light of your stage of
development, lack of revenues, and “current economic turmoil.”;
• Clarify the nature of the “other ope rating expenses” mentioned on page 23;
and
• Please tell us how you have communi cated and will communicate with
potential investors consistent with Section 5 of the Securities Act, in light of
this pending registration statement.
 Nine Months Ended September 30, 2008 and 2007, page 24

Kevin R. Davidson
BioDrain Medical, Inc.
January 29, 2009 Page 6  17. You indicate that cash used in operations in 2008 was impacted by an “increase in
escrow cash.”  Please tell us what you m ean by “escrow cash” and explain to us
why that item is appropriately report ed as an operating activity under SFAS 95.
18. Tell us the terms of the “escrow cash” and explain where the “escrow cash” is presented in the balance sheet.  If included in cash, tell us why that classification
is appropriate in GAAP.
19. You also indicate that cash used in operating activities in 2008 was increased by an “increase in vested options.”   Plea se revise to clarify what you mean by an
“increase in vested options ” and how that increase impacted cash flows from
operations.
Commitments and Contingencies, page 26

20. Please reconcile the amount of debt on the contractual obligation table to the balance sheet as of September 30, 2008 on page F-3.  Explain how $11,800 of
“long-term debt” can be due in less than one  year.  Please also revise to present
the $10,000 notes payable and the current portion of long-term  debt on the table.

Stock Options and Warrants, page 28

21. For each issuance in the transactions be ginning on page 31, state the warrant or
option exercise price.

Description of Business, page 35

Overview, page 35
   22. Please reconcile your response to prior comment 38 with exhibit 3.1, which was
included as an exhibit to your original filing.
   23. We note your response to prior comment 39; however, we also note that you
continue to make claims regarding the sa fety and efficacy of your product.  For
example, you state on page 39 that the FMS “greatly reduces” safety issues and is
“uniquely positioned to dominate its market segment.”  You also state on page 40 that your product is “unique” and disclose on page 44 that FMS will “redefine the manner in which [infectious fluid] is colle cted, measured and di sposed.”  Please
reconcile these statements with your re sponse to prior comment 60 and the fact
other companies have already developed and sold fluid collection and disposal
systems in your target market withou t exposure to healthcare workers.
     Private Placement Financing, page 35

 24. Disclose the date or dates when th e warrants become exercisable.

Kevin R. Davidson
BioDrain Medical, Inc.
January 29, 2009 Page 7   Current Techniques of Collecting Infectious Fluids, page 37

25. We note your response to prior comme nt 49.  Clarify how your product will
“significantly reduce the risk of healthcare worker exposure” to infectious fluids,
as stated in the second paragraph on page 38, given your disclosure in the
following paragraph regarding products al ready developed and marketed by your
competitors that “address the deficiencies described above.”  Also expand the last
bullet point on page 40 to compare how the competitors’ products mentioned in
the second paragraph on page 38 ar e different from your own.
 The Fluid Management System (FMS), page 38

26. Regarding your responses to prior comments 42 and 55:

• Clarify how the estimated installation cost disclosed on page 50 accounts for
the uncertainty regarding the accessibility of sewer lines and suction systems
noted on page 39.  Also clarify the basis for your estimates regarding the cost
and time of installation, given that it a ppears you have not yet installed your
product in any facility; and
• Revise the last sentence of the penultimate paragraph on page 39 to clarify whether the information in that senten ce reflects your opinion.  Your current
disclosure appears to attribute such in formation to third parties; and
 27. We note your response to prior comment 43.  While your disclosure on pages 40
and 52 refers to “established timeframes and plans” for the regulatory process, it appears that the work you have done in  preparation of your submission to the
FDA solely involves the hiring of regulatory consultants.  Please revise to clarify
what work, if any, you have done in prepar ation of that submission.  For example,
have you or your regulatory consultant begun compiling any of the documents or
preparing the “Submittal Document” referenced on page 52?

Patents and Intellectual Properties, page 41

28. We note from your response to prior comment 45 that you “do not expect to
acquire ownership of any patent rights or claims pertaining to such fluid.”
Expand to state whether you currently have  any intellectual property rights with
respect to your disposable cleaning kit.  Also disc lose whether you have any
agreements with any party regardi ng the disposable cleaning kit.
 29. Please clarify how the continuous operat ion feature mentioned in the last
paragraph on page 41 provides you with a significant competitive advantage,
given your disclosure on page 37 that cu rrent techniques and products are also
capable of continuous operation.

Kevin R. Davidson
BioDrain Medical, Inc.
January 29, 2009 Page 8   The Disposable Cleaning Kit, page 43

30. Please expand your response to prior co mment 47 to disclose all material
obstacles to achieving the “razor blade business model” referenced in your
disclosure.  For example, given your re sponse to prior comment 45 regarding your
lack of intellectual propert y rights to the cleaning kit,  including the “special
adapter,” it appears that medical providers  could use kits made by others rather
than those made by you.  Please revise.

31. Please tell us how the “forecast” menti oned in the second paragraph under this
caption satisfies the requirements of  Item 10 of Regulation S-K.

Drainage Systems, page 46

32. Please reconcile your disclosures here and the second and third paragraphs on page

December 10, 2008

Mail Stop 3030

 Kevin R. Davidson Chief Executive Officer 2060 Centre Pointe Boulevard, Suite 7 Mendota Heights, Minnesota  55120
Re: BioDrain Medical, Inc.
Registration Statement on Form S-1 Filed November 12, 2008
  File No. 333-155299

Dear Mr. Davidson:

We have reviewed your filing and have the following comments.  Where
indicated, we think you should re vise your document in response to these comments.  If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary.  Please be as deta iled as necessary in your explanation.  In
some of our comments, we may ask you to provi de us with information so we may better
understand your disclosure.  After reviewing th is information, we may raise additional
comments.
Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure  requirements and to  enhance the overall
disclosure in your filing.  We look forward to  working with you in these respects.  We
welcome any questions you may have about our comments or any other aspect of our review.  Feel free to call us at the telephone numbers listed at the end of this letter.

Fee Table

1. Please reconcile your disclosures here and on pages 27 and 58 regarding the
number of warrants issued by you in your August 2008 financing.
    2. Given that there does not appear to be an  existing market for your securities, your
reference to Rule 457(c) appears to  be inapplicable.  Please revise.
 Prospectus Cover Page

 3. Because there is no current market for the registrant’s securities, please revise to
clarify that the selling shareholders will sell at a specified fixed price per share
until the registrant’s shares are quoted on the OTC Bulletin Board (or other

Kevin R. Davidson
BioDrain Medical, Inc.
December 10, 2008 Page 2
specified market) and thereafter at prevaili ng market prices or privately negotiated
prices.

4. We note that you are registering the resale of 620,096 common shares underlying
warrants that are issuable upon conversion of notes.  Because the warrants have
not yet been issued, it is premature to  register the underlyi ng common shares for
resale.  Please remove them from this registration statement.

Prospectus Summary, page 1

Our Company, page 1

5. Please disclose that you have not yet requested or received FDA regulatory
clearance to market and sell your products.
 Risk Factors, page 3

 6. Include a risk factor to discuss the antic ipated restructuring in the event you do
not obtain FDA approval by August 2009, and di scuss the risks this presents to
potential investors.
 7. We note the disclosure on page 49 regardi ng registration of a cl ass of your equity
securities under the Exchange Act.  Please tell us when you plan to register a class
of your securities.  If you do not intend to re gister a class of securities before this
registration statement is  effective, please:

• disclose the risks related to termina tion of periodic disclosure due to the
automatic reporting suspensi on under Section 15(d) of th e Exchange Act; and
• explain the effect of the inapplicability of the proxy rules and Section 16 of
the Exchange Act.
 8. It appears from your disclosure on pages 3, 25 and 58 that you recently approved
a reverse stock split that re duced the number of shares you are authorized to issue
to 11,970,994.  We also note that you will be submitting a proposal to your
shareholders for approval to increase the number of authorized and unissued
shares.  Please ensure that shareholder approval is obtained prior to requesting
acceleration of this registration statement so  that the shares being registered for
issuance are actually authorized.

Because we are a development stage company . . ., page 3

 9. Please reconcile your disclosure here and on page 13 regarding whether you will receive proceeds from this offering.  If the proceeds you will receive from this

Kevin R. Davidson
BioDrain Medical, Inc.
December 10, 2008 Page 3
offering depend solely on whether the hol ders of outstanding warrants exercise
those securities, then please revise to clarify that fact here.

Our business would be materially a nd adversely affected . . ., page 4

10. Please clarify the nature of your interest in the intellectual property you claim.
For example, you indicate in the first se ntence on page 5 that the intellectual
property developed by Mr. Ryan was “lic ensed” to you.  However, the last
sentence of this risk factor states that you are the “exclusive owne r of the patent.”
Additionally, you indicate on pages 1 and 4 that you own patent and patent-
pending rights and disclose on page 32 th at you are the assignee of “the patent-
pending product.”
 11. We note the disclosure that Mr. Ryan was added as a named inventor to the
pending patent application.  We also not e the disclosure that you removed from
the U.S. patent application Messrs. Nord a nd Drogue as inventors.  However, it is
our understanding that Messrs. Nord and Drogue  continue to be listed as inventors
on the pending application and that Mr. Ryan  is not listed as an inventor.  Please
revise or advise.

We face intense competition . . ., page 5

 12. Please provide us with supplemental suppor t for the data referenced in your
prospectus, marking the relevant sections to support the disclosure.  For example,
you cite to Frost & Sullivan here and page  28.  You also cite to numerous other
publications throughout your “Description of  Business” section.  Also, please tell
us whether the studies and articles you cite were financed by you or performed at your direction and whether the authors have consented to use of their name in this document.
 13. It is generally inappropriate for a risk f actor to contain language that mitigates the
risk discussed.  We note specifically th e discussion at the end of the first
paragraph regarding the “distinct advantag es” of your product.  Also, it appears
that Stryker and other competitors have  designed systems that also eliminate
handling and exposure to infectious fluids, so the disclosure, if  retained, should be
more balanced.

Our products require FDA approval . . ., page 6

14. Given the variety of uncertainties discusse d in this risk fact or, please revise the
first paragraph to remove your belief th at “the likelihood of regulatory approval
for our products is very high.”

Kevin R. Davidson
BioDrain Medical, Inc.
December 10, 2008 Page 4  15. Expand to discuss your obligation to obt ain FDA approval by the end of August,
2009, and the related risks if you have not done so, as described on pages 39 and 40.
   There is currently no public tr ading market . . ., page 8

 16. Please clarify when you anticipate submitti ng an application for quotation to the
OTC Bulletin Board.  Also disclose any obstacles that exist before such an
application will be submitted and accepted.  For example, it is our understanding
that an application for quotation must be submitted by a market maker.  Has a market maker already committed to submitting such an application?
 If our common stock is accepted for quotation . . ., page 9

17. We note the reference here and your prospectus cover page to applying for trading
on the Nasdaq or NYSE markets.  Please disclose here and on your cover page
whether you currently meet the objective li sting criteria for those markets.  Also
disclose here what hurdles remain before you will satisfy those criteria.
 Other Securities For Issuance Upon Certain Contingencies, page 18

18. Please disclose the identities of the pe rsons with whom you entered into the
agreements mentioned here.  Also descri be the nature of the services to be
provided by the regulatory consultant and file that agreement as an exhibit.
Include a description of the purpose of th e provision requiring the attainment of
performance goals and disclosure of those performance goals.

19. Please expand the notes to financial st atements to describe the equity
arrangements disclosed under this heading.  Your disclo sure should fully describe
the accounting applied or that will be a pplied, as appropriate, and the basis in
GAAP for that accounting.  The disclosure  should also describe the specific
performance goals and any other conditions of the grants that impact vesting or
exercisability.  Refer to SFAS 123(R) for fu rther guidance.  Please ensure that the
notes to financial statements include di sclosure about all obl igations to issue
equity securities, including contingent obligations.

Management’s Discussion and Analysis . . ., page 20
 20. We note your disclosure that your capital requirements for the next 12 months are
expected to be “rather moderate.”  Pl ease reconcile this statement with your
disclosure on page 3 that you will need to raise at least $3 million in order to have sufficient financial resources to fund our  operations for the next 12 months and

Kevin R. Davidson
BioDrain Medical, Inc.
December 10, 2008 Page 5
your disclosure on page 22 that you antic ipate needing a secondary financing
during 2009.

Critical Accounting Policies and Estimates, page 20

21. Please revise to provide a discussion of  your critical accounting policies and
estimates.  This discussion should pres ent your analysis of  the uncertainties
involved in applying an accounti ng principle at a given time  or the variability that
is reasonably likely to result from its application over time. You should address
specifically why your accounting estimates or assumptions bear the risk of
change. For example, it appears that ther e is significant judgment in valuing stock
options and warrants.  Refer to FR-72.

Results of Operations, page 21
22. We see that general and administrative e xpense increased in the six months ended
June 30, 2008 in part due to $91,400 of “produc t development” costs.  In addition,
you disclose that research and developm ent costs increased to $91,400 for the six
months ended June 30, 2008.  Please explain whether these disclosures are
referring to the same expenses and, if so, how they can be included in two
different expense classifications.  Please revise as appropriate.
23. Please revise to discuss the reasons fo r the increase in legal fees of $78,500 and
salaries of $68,100 for 2008 compared to 2007.
24. We reference the disclosure that resear ch and development expense increased in
2008 due to “an accumulation of unbilled work from 2003 to 2007” and the
discussion of the increase in research  and development expense in 2006 due to
“unbilled development fees since inception.”   Please revise to discuss the nature
of the unbilled work, the timing of the billings for work performed and the
circumstances that resulted in th e aforementioned increased expenses.
25. As a related matter, it would appear unus ual for a third party to incur billable
work since 2003 without billing and paym ent.  If you have incurred costs or
entered into other transactions with related parties, such as non-employee
shareholders, please ensure that the notes to  financial statements provide all of the
disclosures required by SFAS 57.

26. With a view toward disclosure, tell us to whom the $91,400 was paid.
 27. You disclose that accrued payroll to taling $336,600 was “eliminated” in 2007.
Please expand the notes to financial statements to describe this significant transaction and the accounting applied.  If these individuals were also
shareholders, it is not clear why the “elimination” of these salaries is not a capital

Kevin R. Davidson
BioDrain Medical, Inc.
December 10, 2008 Page 6
contribution.  Accordingly, please expl ain to us the basi s in GAAP for your
accounting.  We refer you to APB 26.
 28. Further, please clarify in MD&A why general and administrative expenses for six months ended June 30, 2007 are 153,900 but general and administrative expenses
for the year ended 12/31/07 are $125,300.  If th is is related to the “elimination” of
payroll, please elaborate by providing additional disclosu re in your MD&A.

Liquidity and Capital Resources, page 21

29. We note your disclosure on page 22 regard ing sufficiency of funds through the
first half of 2009 and anticipated need fo r a secondary financing.  We also note
your disclosure on page 3 regarding the need to raise $3 million to fund your
operations for the next 12 months.  Pl ease provide investors with a better
understanding of your currently known capital requirements and amounts needed
to satisfy your outstanding obligations.  For example, discuss and quantify, among
other things:

• the accrued payroll expenses as of June 30, 2008 noted on page 3;
• the amounts necessary to seek and obtain approval from the FDA and Underwriters Laboratories mentioned on page 39;
• the expenses you will incur in connection with this offering, as noted on page II-4;
• the fees you owe in connection with your August 2008 financing, as noted on
page 4;
• any ongoing payments required by you to satisfy outstanding debt, such as the
instruments mentioned on page 23, in cluding if the holders of those
instruments decide not to receive  shares in lieu of cash; and
• the amount you will need to satisfy your reporting obligations under the
Exchange Act.
 Please also provide your assessment of the accessibility of and risks to accessing needed capital.  For example, will your doubts about your ability to continue as a
going concern make your access to needed capital more difficult or expensive?
How does your statement regarding su fficiency of funds account for the
uncertainty regarding whether holders of  your outstanding warrants will exercise
those securities?

30. We see that you have experienced recu rring operating losses and negative cash
flows.  We also note that you will need significant additional capital to fund the
development of your business.  Please e xpand the disclosure in this section to
discuss the following:

Kevin R. Davidson
BioDrain Medical, Inc.
December 10, 2008 Page 7
• Your plan of operation for the next  twelve months, including a how you
expect to obtain addition al financing and plans for the “secondary financing”
that is anticipated in 2009;
• The effect of the current economic conditions on your operating plans;
• A summary of any product research a nd development that you will perform
for the term of the plan;
• An indication of the amount of cash that will be required to bring your
products under development to market;
• Any expected purchase or sale of pl ant and significant equipment; and
• Any expected significant changes in the number of employees.

Refer to Item 303 of Regulation S-K.
 Six Months Ended June 30, 2008 and 2007, page 22

 31. Please clarify how net cash provided by fi nancing activities increased during the
six months ended June 30, 2008 due to the receipt of investment capital from a
private offering that occurred subs equent to that period.

Commitments and Contingencies, page 22

 32. From your disclosure on page 23, it appears that notes payable previously issued
by you are now overdue.  Please disclose th e potential consequences of failing to
make required payments on these instrume nts, such as quantification of the
monetary payments mentioned on page 59.  Please also refer to our first comment
under the heading “Liquidity and Capital Resources.”
 33. Please disclose the number of shares into which the $100,000 note payable may
be converted.  Given the dates on which exhibits 10.20 and 10.21 were executed and the disclosure in your document regarding the August 2008 private placement, it appears that the “next completed financing” has already occurred.

Stock Options and Warrants, page 24

34. Please tell us why your tables here and page 25 do not include

• the stock option issuance to Mr. Ruwe on June 16, 2008 that is mentioned on
page 46;
• the stock option grant to Mr. Davidson  on June 5, 2008 that is mentioned on
page 44; and

Kevin R. Davidson
BioDrain Medical, Inc.
Decembe