Posts Tagged ‘LLC’

By: The Advanced Medical Technology Association (“AdvaMed”), prepared by Josh Makower, M.D., consulting Professor of Medicine, Stanford University and Founder, President & Chief Executive Officer of ExploraMed Development. Article reposted from The Coelyn Group.

OneMedPlace recently reported that “Growth in the life sciences industries will greatly depend on how the FDA responds to growing complaints that they are stifling medical technologies.  Companies have seen a vast difference in the approval processes in Europe vs. the U.S.  A study released by Stanford University indicated that the cost of bringing a technology to market is dramatically lower in Europe.”

The Advanced Medical Technology Association (“AdvaMed”) recently released the report, prepared by Josh Makower, M.D., consulting Professor of Medicine, Stanford University and Founder, President & Chief Executive Officer of ExploraMed Development, LLC; et al, “FDA Impact on U.S. Medical Technology Innovation,” which garnered responses from more than 200 companies concerning their experiences in working with the FDA.  Participants were also asked about their experiences working with European regulatory authorities in order to offer a comparison between aspects of the two dominant regulatory systems.

“In general, survey respondents viewed current U.S. regulatory processes for making products available to patients as unpredictable and characterized by disruptions and delays,” the results summary states.  Forty-four percent (44%) indicated that part way through the premarket regulatory process they experienced untimely changes in key personnel, including the lead reviewer and/or branch chief responsible for the product’s evaluation.  Thirty-four percent (34%) of respondents also reported that appropriate FDA staff and/or physician advisors to the FDA were not present at key meetings between the FDA and the company.”

The report goes on to highlight that those factors contribute to significant delays in navigating FDA regulatory processes, with premarket process for 510(k) pathway devices (of low-to moderate risk) taking an average of 10 months from first filing to clearance.  Devices requiring a clinical study for low- to moderate-risk devices before making a regulatory submission, the premarket process took an average of 31 months from first communication to being cleared to market while, in comparison, it took an average of 7 months in Europe.

For higher risk devices seeking premarket approvals, responding companies indicated that it took an average of 54 months to work with the FDA from first communication to being approved to market the device.  In Europe, it took an average of 11 months.”

Beyond the time gap comparing FDA and Europe approval processes, the survey also showed that the average total cost for a low- to moderate-risk 510(k) product from concept to clearance was approximately $31 million, with $24 million spent on FDA dependent and/or related activities.  For a higher-risk PMA product, the average total cost from concept to approval was approximately $94 million, with $75 million spent on stages linked to the FDA.

According to the report, these statistics result in a “significant, measurable cost to U.S. patients in the form of a device lag.  Respondents reported that their devices were available to U.S. citizens, on average, nearly 2 full years later than patients in other countries, due to delays with the FDA and/or company decisions to pursue markets outside the U.S. before initiating time-consuming, expensive regulatory processes in their own country.”

Stephen J. Ubl, President & Chief Executive Officer of AdvaMed, says, “This report is a wake-up call for those who want to promote medical innovation and preserve American jobs.  A regulatory environment that is marked by needless delays and inefficiencies makes it harder for medical innovation to thrive and companies to survive.  These delays particularly hurt small companies and their ability to produce next generation technologies.”

To read the full report go to: http://www.advamed.org/NR/rdonlyres/040E6C33-380B-4F6B-AB58-9AB1C0A7A3CF/0/makowerreportfinal.pdf

Ultimately, growth within the life sciences will continue at a quick pace during the next few years, with development of R&D pipelines, alliances, and partnerships being a key factor for success.

As the economy continues to chug back to full force, the only obstacle appears to be the differing of opinions between the medical device manufacturers and the FDA.  Perhaps if they come to a meeting of the minds, these growth projections will not just be projections, but will be the reality of a growing field that is quickly, and effectively, delivering what the U.S. healthcare system requires.”

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Gerbsman Partners (www.gerbsmanpartners.com) has been retained by Emigrant Bank (“Emigrant”) to solicit interest for the acquisition of all, or substantially all, assets of OmniSonics Medical Technologies, Inc. (“OmniSonics”).  OmniSonics was a leader in commercializing technology that uses ultrasound technology to break up blood clots.
A copy of the proposed purchase agreement is attached as Exhibit A, as well as a confidential information memorandum and related documents.  A Purchaser who wishes to participate in the auction must submit a sealed bid which is actually received by Emigrant no later than Friday, November 6, 2009 (the “Bid Deadline”).

The assets of OmniSonics are attractive for a number of reasons:

· FDA approved product indicated for the removal of thrombus in the peripheral vasculature and the infusion of physician specified fluids.
· Intellectual Property: a comprehensive patent estate which includes 20 issued patents and 16 pending patent applications in the U.S., as well as 6 issued patents and 13 pending patent applications outside of the U.S. Many of the key patents which cover apparatus, methods and uses do not expire until 2022.  A list of the intellectual property is attached as Exhibit B.
· Preliminary Prospective, Registry Patient Data Set for removal of thrombus in patients with Deep Vein Thrombosis (DVT) Sonic I.
· Preliminary Prospective, Registry Patient Data Set for removal of thrombus in patients with Acute Limb Ischemia) Sonic II.
· Manufacturing, Design and Calibration Equipment.
· Relationships with Third Party Manufacturers that can assist with the production of saleable product.

OmniSonics  Company Profile

Founded in 1999, OmniSonics was a private, Wilmington, MA-based revenue stage medical device company. Over the past 10 years, OmniSonics raised approximately $100MM in equity and debt from leading venture capital firms including GE Asset Management, Nomura Phase4 Ventures, Domain Associates, H&Q Asset Management and Canaan Partners.

Bankruptcy Case. On March 23, 2009, OmniSonics filed a chapter 7 bankruptcy case in the United States Bankruptcy Court for the District of Massachusetts.  John J. Aquino is Trustee. Emigrant’s affiliate, Life Sciences Capital, LLC, was a prepetition lender to OmniSonics and Emigrant has entered into a transaction with the Trustee to purchase substantially all of the assets of OmniSonics, including its intellectual property. Emigrant has retained Gerbsman Partners to conduct a sale of these assets.  Some of the former employees of OmniSonics may be available to assist purchasers with due diligence and a prompt, efficient transition to new ownership. Notwithstanding the foregoing, former employees or officers of OmniSonics and the Trustee should not be contacted directly without the prior consent of Gerbsman Partners.

Assets Being Sold. The assets which are being sold consist of substantially all of the intellectual property of OmniSonics including issued patents and trademarks, related records, patent applications, and certain equipment.   These are referred to as the “Assets.”


The information in this memorandum does not constitute the whole or any part of an offer or contract.

The information contained in this memorandum relating to the Assets has been supplied by former executive officers of OmniSonics and the Trustee. It has not been independently investigated or verified by Gerbsman Partners or their respective agents.

Prospective purchasers should not rely on any information contained in this memorandum or provided by Gerbsman Partners (or their respective staff, agents, and attorneys) in connection with the proposed sale, whether transmitted orally or in writing as a statement, opinion, or representation of fact. Interested parties must satisfy themselves through independent investigations and due diligence as they see fit.

Gerbsman Partners, and their respective staff, agents, and attorneys: (i) disclaim any and all implied warranties concerning the truth, accuracy, and completeness of any information provided in connection with the proposed sale and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reasons of OmniSonics’ or Gerbsman Partners’ negligence or otherwise.

Any sale of the OmniSonics Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either express or implied, of any kind, nature, or type whatsoever from, or on behalf of OmniSonics, Gerbsman Partners, Emigrant or the Trustee. Without limiting the generality of the foregoing, the foregoing parties and their respective staff, agents, and attorneys,  hereby expressly disclaim any and all implied warranties concerning the condition of the Assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, the implied warranties of habitability, merchantability, or fitness for a particular purpose.

Please refer in the Confidential Information Memorandum to the section on Legal Considerations for further information about these matters, and the section on Bidding Procedures for information about bidding procedures.


1. Each person or entity who is or may be interested in bidding for and purchasing all or some of the Assets shall be referred to as “Purchaser.” Each Purchaser who executes the Confidentiality Agreement may request access to former personnel of OmniSonics who may be made available and access to the “Data Room” which includes various documents (the “Diligence Access”).  Any Purchaser seeking access to OmniSonics personnel or who wishes to request additional information should contact Gerbsman Partners.  Each Purchaser who executes the Confidentiality Agreement and obtains the Diligence Access (whether or not such Purchaser has obtained all or some portion of the personnel and access materials) shall be deemed to acknowledge and represent:  (a) that it is bound by the bidding procedures described herein; (b) that it has had an opportunity to inspect and examine the Assets and to review pertinent documents and information with respect thereto; (c) that it is not relying upon any written or oral statements, representations, or warranties of Gerbsman Partners or Emigrant; and (d) all such documents and reports have been provided solely for the convenience of the interested party, and Gerbsman Partners and Emigrant do not make any representations as to the accuracy or completeness of the same.

2. A Purchaser who wishes to participate in the auction must submit a sealed bid, which is to be received by Emigrant no later than Friday, November 6, 2009 (the “Bid Deadline”), to Karen Wold, Emigrant Bank, 6 East 43rd Street, 20th Floor, New York, New York 10017 and e-mailed to:  Woldk@emigrant.com and steve@gerbsmanpartners.com.  The bid shall contain:  (a) a list or identification of the Assets such Purchaser wishes to purchase; (b) the amount of the bid; (c) any proposed changes to the Purchase Agreement and all exhibits and schedules, with redline to show all such changes and (d) any other information that Purchaser deems relevant.  All bids must be accompanied by a refundable deposit check in the amount of $50,000 (payable to Emigrant).

In addition:

(a) Bids may be made for all or any portion of the Assets.

(b) Any Purchaser making a bid must be prepared to provide independent confirmation that it possesses the financial resources to complete the purchase.

(c) Emigrant reserves the right to, in its sole discretion, extend the Bid Deadline, accept or reject any bid, or withdraw any or all Assets from the sale.

(d) Emigrant shall determine the highest and best bid and may contact Purchasers regarding their bids prior to the final determination.  The winning bidder will be notified as soon as possible after the Bid Deadline. Unsuccessful bidders will have their deposits returned to them.

(e) A successful Purchaser with regard to some or all of the Assets will be required to increase its deposit to $200,000 within 24 hours of being notified it is a successful Purchaser and be prepared to close within seven (7) days of being notified that its bid has been accepted. All sales, transfer, and recording taxes, stamp taxes, if any, relating to the sale of the Assets shall be the sole responsibility of the successful bidder and shall be paid to Emigrant at the closing of each transaction.  If the successful bidder fails to close, Emigrant may retain the deposit, exercise any remedies under applicable law and subsequently sell to another party.

(f) Any Purchaser who bids shall have no remedy against Emigrant or Gerbsman Partners or any other person except for the return of its deposit; provided, that, any Purchaser who enters into an Asset Purchase Agreement shall have all remedies under such Agreement and under applicable law.

(g) Copies of all bids should be sent by e-mail to steve@gerbsmanpartners.com


For additional information, please do not contact OmniSonics or the Trustee directly; instead please contact:

For additional information, please see below and/or contact:

Steven R. Gerbsman
(415) 456-0628

Dennis Sholl
(415) 457-9596

Kenneth Hardesty
(408) 591-7528

Other covering this topic include: Xconomy, Taragana.

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