SEC Comment Letter for InspireMD, Inc. (NSPR) (CIK 0001433607) (NSPR) — Oct 5, 2011
InspireMD, Inc. (NSPR) (CIK 0001433607)
Date: Oct. 5, 2011 · CIK: 0001433607 · Accession: 0000000000-11-058925
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File numbers found in text: 333-174948
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October 5, 2011 Via E-mail Ofir Paz Chief Executive Officer InspireMD, Inc. 3 Menorat Hamaor St. Tel Aviv, Israel 67448 Re: InspireMD, Inc. Amendment No. 2 to Registrati on Statement on Form S-1 Filed September 21, 2011 File No. 333-174948 Dear Mr. Paz: We have reviewed your registration statem ent and have the following comments. In some of our comments, we may ask you to provi de 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. 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 re gistration statement and the information you provide in response to these comments, we may have additional comments. Risk Factors, page 5 1. We note your response to prior comment 6. Plea se add separate risk factors to highlight the risks related to your operati ons in Israel. Also, include a risk factor that highlights that investors may experience difficulties in attempting to enforce judgments based upon U.S. federal securities laws against your non-U.S. resident direct ors and officers. 2. We note your response to prior comment 8. Please add a risk factor to highlight that your distributors have a contractua l right to return all purchas es to you for up to eighteen months from the purchase date. We are subject to financial reportin g and other requirements, page 15 3. Please update the disclosure to clarify wh ether you have accomplished any of the objectives mentioned in the fourth sentence of this risk factor. Ofir Paz InspireMD, Inc. October 5, 2011 Page 2 Our Products, page 29 4. Your revisions in response to prior comm ent 11 do not address the myocardial blush grade or rates of adverse car diac events of other bare-met al and drug-eluting stents. Revise your disclosure in this section to provide comparative data for your competitors. Pre-Clinical Studies, page 31 5. We note your response to prior comment 14. Pl ease clarify that th e trials in 2005 and 2006 were limited to animal testing. Also, cl arify that the comparisons mentioned in the fourth and fifth sentences of this secti on were based only on animal testing and not meaningfully connected to human subjects. Clinical Trials, page 32 6. Please revise the prospectus to provide the in formation set forth in your response to prior comment 13 regarding the reasons for your trial delays. Also, tell us why your tabular disclosure in this se ction does not include your clinical trial in Brazil mentioned in the fifth paragraph on page 34. Growth Strategy, page 37 7. We note your response to prior comment 17. Pl ease update the disclo sure regarding the strategies mentioned in the bu llet points in this section. Fo r example, update to disclose whether you have partnered with companies as mentioned in the last bullet point. Patents, page 40 8. Please expand this section to disclose, if know n, the reasons for the de lays regarding your patent filings. We note the disclosure in th is section that none of your 35 filed patents have been granted. Government Regulation, page 41 9. We note your response to prior comment 16. Pl ease reconcile the di sclosure in this section that you need to submit applications for regulatory approval in various countries with the disclosure on page 23 that your produc t has been sold in t hose countries. Also, expand this section to disclose the material government regulations in Israel concerning your product. Customers, page 42 10. Please update the disclosure concerning your ma terial customers. For example, we note the disclosure on page F-48 that a custom er from India accounted for 40% of your Ofir Paz InspireMD, Inc. October 5, 2011 Page 3 revenues in the six months ended June 30, 2011. Also, disclose the terms of your agreements with your material customer and file the agreements as exhibits. Legal Proceedings, page 43 11. We note your response to prior comment 25. Plea se update the disclosu re in this section concerning litigation with Mr. Mayor and litigation disclosed on page F-50. Agreements with Executive Officers, page 45 12. Please clarify that you entered into consulti ng agreements with A.S. Paz Management and Investment Ltd. and Israeli Society Ltd. through which you retained Mr. Paz to serve as your chief executive officer and Dr. Holzer to serve as your presid ent. Also, tell us, with a view to disclosure, w hy you entered into consulting agreements with these entities instead of employment agreements with Mr. Paz and Dr. Holzer. Certain Relationships and Relate d Party Transactions, page 55 13. Please provide the disclosure required by Item 404(a) of Regulation S-K. For example, we note that you do not disclose in this sec tion the consulting agreements with A.S. Paz Management and Investment Ltd. and Isra eli Society Ltd and the related party transactions disclosed in Note 9 on page F-19. Also, tell us where you filed as exhibits the agreements mentioned in Note 9. Financial Statements for the Years Ended December 31, 2010 and 2009 Note 10 – Commitments and Con tingent Liabilities, page F-20 c. Litigation, page F-21 14. Please refer to our prior comment 25. Please revise your disclosure to provide an explanation, similar to the one provided in your response, of why you recorded the $134,000 and $53,000 of expenses in the year ended December 31, 2006 even though the claims were not submitted until 2010. In particular, include disclosure of your conclusion that the conditions requiring you to record each charge existed in fiscal 2006 at the time of the events that gave rise to the litigation and were not triggered by the formal claims filed by the plaintiffs in fiscal 2010. 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. Ofir Paz InspireMD, Inc. October 5, 2011 Page 4 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; 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. You may contact Julie Sherman at (202) 551-3640 or Jeffrey Jaramillo, Accounting Branch Chief, at (202) 551-3212 if you have que stions regarding comments on the financial statements and related matters. Please contac t Tom Jones at (202) 551-3602 or Daniel Morris, Special Counsel, at (202) 551- 3314 with any other questions. Sincerely, /s/ Daniel Morris for Amanda Ravitz Assistant Director cc (via e-mail): Rick A. Werner, Esq.