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SEC Comment Letter for Predictive Oncology Inc. (AGPU) (CIK 0001446159) (AGPU) — Jul 21, 2009

Predictive Oncology Inc. (AGPU) (CIK 0001446159)
Date: July 21, 2009 · CIK: 0001446159 · Accession: 0000000000-09-038705

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File numbers found in text: 333-155299

Referenced dates: May 14, 2009

Date
July 21, 2009
Author
Not clearly detected
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UPLOAD
Company
Predictive Oncology Inc. (AGPU) (CIK 0001446159)

Letter

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 If that provision is no longer applicable to those securities, please ensure that the disclosures you provided pursuant to Items 403 and 507 of Regulat ion S-K are updated accordingly.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

Show Raw Text
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