Archive for November 27th, 2012

SALE OF Coherex Medical FlatStent Assets & Intellectual Property
Gerbsman Partners (www.gerbsmanpartners.com) has been retained by Coherex Medical Inc. (http://coherex.com) to solicit interest for the sale of all, or substantially all, the Assets & Intellectual Property pertaining to its FlatStent PFO technology (“COHEREX MEDICAL Assets”).

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

The information contained in this memorandum relating to COHEREX MEDICAL’s Assets has been supplied by COHEREX MEDICAL. It has not been independently investigated or verified by Gerbsman Partners or its agents.

Potential purchasers should not rely on any information contained in this memorandum or provided by COHEREX MEDICAL, or Gerbsman Partners (or their respective staff, agents, and attorneys) in connection herewith, whether transmitted orally or in writing as a statement, opinion, or representation of fact. Interested parties should satisfy themselves through independent investigations as they or their legal and financial advisors see fit.
COHEREX MEDICAL, 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 herewith and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reasons of COHEREX MEDICAL’ or Gerbsman Partners’ negligence or otherwise.

Any sale of the COHEREX MEDICAL 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 COHEREX MEDICAL or Gerbsman Partners. Without limiting the generality of the foregoing, COHEREX MEDICAL and Gerbsman Partners and their respective staff, agents, and attorneys,  hereby expressly disclaim any and all implied warranties concerning the condition of the COHEREX MEDICAL 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.

This memorandum contains confidential information and is not to be supplied to any person without Gerbsman Partners’ prior consent. This memorandum and the information contained herein are subject to the non-disclosure agreement attached hereto as Exhibit A.

Coherex Medical Company Profile
Coherex Medical, Inc.(the Company) was founded in 2003 to design, develop, and market innovative catheter-based technologies for the treatment of structural heart defects. The Company is led by President and CEO Alex Martin who has over 30 years experience in the medical device industry.  Alex is supported by a management team that has on average more than 25 years of experience in medical device design and development, manufacturing and operations, marketing and sales, quality and regulatory systems, intellectual property protection, and financial and business leadership.

Headquartered in Salt Lake City, Utah, Coherex Medical is a medical device company focused on development and commercialization of innovative customizable structural heart technologies including a Left Atrial Appendage (LAA) occluder called WaveCrest and a Patent Foramen Ovale (PFO) closure device called FlatStent. This sale pertains to the FlatStent PFO assets and technology only.
The Company initially focused on the development of the FlatStent to treat a common heart defect called a patent foramen ovale (PFO), which is present in approximately 25% of the population. PFO has been identified as a potential cause of certain migraines, embolic strokes, transient ischemic attacks (TIAs) and other medical indications. The Coherex FlatStent™ EF PFO Closure System has been designed to maximize safety, efficacy, and ease-of-use in closing a PFO. The device has a CE mark that allows it to be sold in the EU and other countries. The PFO device also has conditional IDE approval.

The company is currently focused on the WaveCrest LAA technology, which is undergoing clinical trials in Europe. The Coherex WaveCrest™ Left Atrial Appendage Closure System, addresses a large and unmet need to prevent strokes in patients suffering from a common heart condition known as atrial fibrillation. Atrial fibrillation (also known as A-fib or AF) is a disturbance of the normal heart rhythm in the upper chambers of the heart.  It results in poor or virtually no contraction of those chambers, which may cause blood to pool and not be ejected from a pouch attached to the left atrium called the Left Atrial Appendage.  A-Fib is the most commonly diagnosed heart rhythm disorder.

To date the company has raised $47.9 million through equity fund raising.  Investors include Oxford Bioscience, vSpring Capital, Tullis Health Investors, Abbott Laboratories, Saints Capital and Johnson & Johnson.
The company is selling the PFO assets to raise funds for its ongoing business which is focused on the LAA technology.

Coherex Medical believes its FlatStent PFO device assets are attractive for a number of reasons:

The Coherex FlatSent is CE Marked, has an FDA approved IDE and represents:

The only in-tunnel PFO closure device approved for sale in CE marked countries
Significant and unique intellectual property related to a PFO closure device providing closure within the tunnel.
The Coherex FlatStent system has received a conditional Investigational Device Exemption (IDE) from the United States Food and Drug Administration.
The FlatStent assets include the QA manuals, manufacturing related materials and processes necessary to manufacture the devices.
The Flatstent device employs dual closure mechanisms.
Lateral forces approximate the septum primum and septum secundum.
Polyurethane foam promotes rapid tissue growth within the PFO tunnel.
The FlatStent provides an extraordinarily small footprint and it has not been associated with complications noted with competing PFO devices including; Thrombus, Erosion, Arrhythmia.
The FlatStent leaves the fossa ovalis open for future procedures which require transseptal puncture.
The FlatStent is delivered to the left atrium in a rapid exchange fashion which eliminates the risk of air embolism.

 Impact of Technology on the Market

COHEREX MEDICAL believes that its FlatStent technology offers advantages over currently marketed double disk PFO closure technologies:

Treats the PFO tunnel ONLY.
Does not cover the walls of the atrial septum.
Minimal atrial exposure to limit thrombus and headache exacerbation.
Very small metal mass with minimum footprint and implant bulk.
Offers minimal impact to the interatrial septum reducing potential complications of septal stiffening, perforation, erosion, arrhythmia, chest pain, and valve distortion.
May be delivered without long access sheaths reducing ancillary device requirements and potential of air embolism.
Implant comes pre-loaded on delivery system reducing preparation time.

Coherex FlatStent Assets

Coherex  Medical has developed a portfolio of assets critical to the development, manufacturing, and marketing of the Flatstent PFO Closure System. These assets fall into a variety of categories, including:

Patents, Patent Applications and Trademarks
CE Mark for Flatstent PFO Closure System
Custom built equipment and tooling for manufacturing Flatstent systems
Key know-how, expertise, and documentation to manufacture PFO Closure System
Patient Data from 4 clinical trials involving 104 patients
The assets of Coherex Flatstent will be sold in whole. (collectively, the “Coherex FlatStent”). The sale of these assets is being conducted with the cooperation of Coherex. Coherex and its employees will be available to assist purchasers with due diligence and a prompt, efficient transition to new ownership.

Notwithstanding the foregoing, Coherex Medical should not be contacted directly without the prior consent of Gerbsman Partners.

Turn-key Manufacturing Process

Coherex has developed a turn-key process to transfer all equipment, documentation, and product knowledge to the buyer. This process will facilitate rapid manufacturing start-up of the FlatStent product.

This turn-key system includes:

Clinical data,
R&D Design History Files (DHF),
Manufacturing and Quality documentation and Marketing materials.

Included in this product portfolio is tooling, fixtures, and equipment that are necessary to manufacture the Flatstent product. A detailed description of all purchase specification and raw material suppliers are included in the Device Master Record (DMR), which is located in the company’s due diligence data room.

Key Personnel

Alex Martin — President & CEO

John Alexander (Alex) Martin joined Coherex Medical as Director, President and CEO starting in July 2012. Mr. Martin has had executive experience with medical device companies such as WorldHeart, Edwards Lifesciences, Cordis Corporation, a Johnson and Johnson (J&J) company and CR Bard. Mr. Martin served in sales, marketing and business development management positions within these several organizations. Mr. Martin earned a bachelor’s degree from the University of Kentucky at Lexington.

Sheri Thomas — Vice President, Finance

Ms. Thomas is a Certified Public Accountant with 24 years experience in public accounting and industry.  The companies for whom she has worked include Price Waterhouse, WordPerfect Corporation, Novell and Phone Directories Company.  She has been with Coherex Medical for three years.

Ronald Watkins— Chief Operating Officer

Mr. Watkins joined Coherex in 2007 and has over 20 years of medical device manufacturing and operational experience. Mr. Watkins has worked with both large medical device companies such as Baxter Edwards and Boston Scientific as well as several start-up companies. He has served a key role in developing engineering and manufacturing processes, implemented quality systems, and is instrumental in developing a culture of success for these companies.

Daryl Edmiston – Vice President, RD

Mr. Edmiston has an extensive background and over 24 years experience in engineering project management, medical device design, and state-of-the-art manufacturing processes. As a private consultant, Mr. Edmiston advised various companies in the semiconductor and medical device manufacturing sector. Before joining Coherex in March 2006, he worked for Rubicon Medical, as Director, and then Vice President of Research and Development.

Abe Mathews – Vice President, Regulatory Affairs

Mr. Mathews began his career in the medical device industry with the Ethicon Division of Johnson & Johnson.  He then joined Provasis Therapeutics, a start up medical device venture,  as Vice President, Regulatory Affairs and Quality Assurance. Mr. Mathews worked for Boston Scientific before joining Coherex Medical over 5 years ago as Vice President, Regulatory Affairs.

Cliff Montagnoli – Vice President, Clinical Affairs

Mr. Montagnoli, VP of Clinical Affairs, joined the Coherex Medical team in February of 2007. His extensive background in the medical industry began in 1991 with clinical research in pediatric cardiology at the University of Utah Medical Center. Other extensive experience includes work with Clinical Innovations (CI), Final Touch Training Group, Shared Technologies and Microsoft. Cliff worked for Rubicon Medical as Manager of Clinical Affairs before joining Coherex

COHEREX MEDICAL, Board of Directors

Brian Whisenant, M.D., Chairman of the Board: Intermountain Health Care

Alex Martin:  Coherex Medical

Kadir Kadhiresan:  Johnson and Johnson

Zack Scott:  Saints Capital

Dinesh Patel, Ph.D.: VSpring Capital

Dan Cole: Oxford Bioscience Partners

Roy Tanaka: Independent

Curt LaBelle: Tullis Healthcare Investors (Board Observer)

Mark Williams, Ph.D.: Abbott Laboratories (Board Observer)

Dave Berger: E.B. Berger (Board Observer)

The Bidding Process for Interested Buyers

Interested and qualified parties will be expected to sign a nondisclosure agreement (attached hereto as Exhibit A) to have access to key members of the management and intellectual capital teams and the due diligence “war room” documentation (the “Due Diligence Access”). Each interested party, as a consequence of the Due Diligence Access granted to it, shall be deemed to acknowledge and represent (i) that it is bound by the bidding procedures described herein; (ii) that it has an opportunity to inspect and examine the COHEREX MEDICAL Assets and to review all pertinent documents and information with respect thereto; (iii) that it is not relying upon any written or oral statements, representations, or warranties of COHEREX MEDICAL, Inc., Gerbsman Partners, or their respective staff, agents, or attorneys; and (iv) all such documents and reports have been provided solely for the convenience of the interested party, and neither COHEREX MEDICAL nor Gerbsman Partners (or their respective, staff, agents, or attorneys) makes any representations as to the accuracy or completeness of the same.

Following an initial round of due diligence, interested parties will be invited to participate with a sealed bid, for the acquisition of the COHEREX MEDICAL Assets. Sealed bids must be submitted so that the bid is actually received by Gerbsman Partners no later than January 4, 2013 at 3:00 p.m. Pacific Standard Time (the “Bid Deadline”) at COHEREX MEDICAL’ office, located at 125 Constitution Drive, Menlo Park, CA 94025.  Please also email steve@gerbsmanpartners.com with any bid.

Bids should identify those assets being tendered for in a specific and identifiable way. The attached COHEREX MEDICAL fixed asset list may not be complete and Bidders interested in the COHEREX MEDICAL Assets must submit a separate bid for such assets. Be specific as to the assets desired.

Any person or other entity making a bid must be prepared to provide independent confirmation that they possess the financial resources to complete the purchase where applicable. All bids must be accompanied by a refundable deposit check in the amount of $200,000 (payable to COHEREX MEDICAL, Inc.). The winning bidder will be notified within 3 business days after the Bid Deadline. Unsuccessful bidders will have their deposit returned to them. COHEREX MEDICAL reserves the right to, in its sole discretion, accept or reject any bid, or withdraw any or all assets from sale.

COHEREX MEDICAL will require the successful bidder to close within 7 business days.  Any or all of the assets of COHEREX MEDICAL will be sold on an “as is, where is” basis, with no representation or warranties whatsoever.

All sales, transfer, and recording taxes, stamp taxes, or similar taxes, if any, relating to the sale of the COHEREX MEDICAL Assets shall be the sole responsibility of the successful bidder and shall be paid to COHEREX MEDICAL at the closing of each transaction.

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

Steven R. Gerbsman
(415) 456-0628

Kenneth Hardesty
(408) 591-7528

Philip Taub
(917) 650-5958

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