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SEC Comment Letter for Predictive Oncology Inc. (AGPU) (CIK 0001446159) (AGPU) — Nov 27, 2012

Predictive Oncology Inc. (AGPU) (CIK 0001446159)
Date: Nov. 27, 2012 · CIK: 0001446159 · Accession: 0000000000-12-064124

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File numbers found in text: 000-54361

Date
December 31, 2011
Author
/s/ Brian Cascio
Form
UPLOAD
Company
Predictive Oncology Inc. (AGPU) (CIK 0001446159)

Letter

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

Show Raw Text
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