
SALE OF NEOGRAFT TECHNOLOGIES, INC.
Gerbsman Partners (www.gerbsmanpartners.com) has been retained by Neograft Technologies, Inc. (www.neograftinc.com) to solicit interest for the acquisition of all, or substantially all, the assets of Neograft Technologies, Inc.
Neograft is a privately held medical device company located in Taunton, MA, founded in April 2009. Neograft is developing a novel, regenerative vascular graft based on its core electrospinning technology. The acquisition of Neograft Technologies will secure critical intellectual property and a substantial database characterizing safety and performance for its products that address a $2 Billion worldwide market opportunity. Neograft Technologies has raised three rounds (some with multiple tranches) of private financing to date totaling $40 million from private investors, a large majority from a single family fund together with other high net-worth individuals.
Neograft Technologies is developing a proprietary vascular graft that promises to improve clinical outcomes, especially in smaller vessels. Its product is designed to become incorporated in the patient’s own tissue and then remodels over time to resemble and function as a native artery. Neograft Technologies has 25 issued US patents, 4 “Notices of Allowance”, 29 pending patent applications worldwide, and two pending trademarks.
Our core technology was first investigated as a reinforcement for saphenous vein CABG grafts, and is based partly on patents licensed from the University of Pittsburgh. This product was evaluated in two clinical feasibility studies in 42 subjects. The results showed encouraging signs of diminished midgraft stenosis and distal anastomotic hyperplasia, but there was a limiting response at the proximal anastomosis.
The regenerative graft is based on the same core technology and has been evaluated in several animal studies. The latest data shows encouraging signs that a similar remodeling behavior can occur using a synthetic implant.
IMPORTANT LEGAL NOTICE:
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 Neograft Technologies’s Assets has been supplied by Neograft Technologies. 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 Neograft Technologies, 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.
Neograft Technologies, 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 Neograft Technologies’s or Gerbsman Partners’ negligence or otherwise.
Any sale of the Neograft Technologies 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 Neograft Technologies or Gerbsman Partners. Without limiting the generality of the foregoing, Neograft Technologies and Gerbsman Partners and their respective staff, agents, and attorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the Neograft Technologies 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.
Historical Company Information
Neograft Technologies was established in 2009 to focus on core technology developed at and licensed from The University of Pittsburgh that focused on saphenous vein reinforcement. The company was located in Pittsburgh for the first two years before relocating to Taunton, MA.
For the first five years, the company focused exclusively on applying its core electrospinning technology on developing an intraoperative system to coat the outside surface of saphenous vein grafts to improve CABG outcomes.
In parallel, the company established an aggressive patent strategy and has created broad patent protection around this concept. In 2015, the company acquired the intellectual property assets of Kips Bay Medical, Inc., a public, Minnesota based company that developed a product for the same CABG indication. Together, the IP of both companies establishes a significant barrier to competition in this market.
Two clinical feasibility studies were conducted in Eastern Europe to evaluate the CABG indication with encouraging signs of attenuated mid-graft and distal disease. However, there was a significant incidence of stenosis at the proximal connection to the aorta.
During the course of extensive experiments in animals (over 200 implants for as long as two years) Neograft discovered that its product facilitated transformation of developing tissue surrounding the product into a structure that resembles a native blood vessel. Based on this discovery, the company decided to refocus its attention on applying the technology as a stand-alone synthetic graft. Much of the core IP developed for the CABG indication overlaps this indication and the company has filed new patent applications that directly cover any new inventions.
Significant progress has occurred toward a clinically usable product and recent animal testing shows encouraging signs that similar remodeling of the polymer structure is feasible.
Neograft Technologies believes this technology provides a potential and sustainable commercial asset in the vascular graft market for the following reasons:
- The US market for peripheral, hemodialysis and coronary bypass grafts is very large and growing. Market growth via displacement of native grafts will occur with a clinically superior product. Surgeons will rapidly adopt as it eliminates the need to harvest pains.
- Peripheral graft failures are as high as 60% at one to three years and outcomes haven’t improved significantly over the past forty years, despite many attempts at a solution to this problem.
- The mechanism of action of this product is similar to several, more-complex bioengineered approaches but can be achieved through simpler and lower-costmanufacturing.
- Currently available heparin coated grafts are priced at 4X uncoated grafts in the US, though there is no significant difference in outcomes. A truly better product will create significant opportunity to grow revenue through increased value.
- The mechanism of action for the product has been demonstrated in animals, with over 200 implants followed as long as two years. The safety of the material and technology has also been demonstrated in humans, in two separate studies enrolling 42 subjects.
- The company has established a vertically integrated, very efficient operation, that is ISO 13485-2016 certified for producing the product.
- The company has established a reliable, working animal model for verifying performance of the product and also a very efficient pathway for verifying clinical performance in humans so final development steps are far more economical than typical products of this type.
- 25 issued US patents, 33 issued patents outside of US, 4 Notices of Allowance received, 12 US applications pending, and 17 applications pending outside of US.
Neograft Technologies Company Profile- Assets of the Company
Neograft Technologies was founded by an expert group of scientists and experienced industry executives to develop and commercialize its novel technology to improve CABG outcomes.
The company has assembled a world-class clinical and scientific advisory board and has created a compact but fully vertical operational capability to develop, test and manufacture its products. It has also established clinical relationships within and outside of the US to effeciently evaluate its products.
Neograft opportunistically acquired the intellectual property assets and data of Kips Bay Medical, a public Minnesota based company that developed a different external reinforcement device for improving CABG outcomes that was incubated at Medtronic until its spin-off in 2007.
Product development and testing has all been conducted within the scope of ISO-13485 and the company is currently certified to ISO-13485 2016.
An extensive database exists characterizing safety and performance in-vitro, in animals and in humans.
Impact of Technology on the Market
This technology enables a novel approach to one of the remaining ‘holy grails’ in the medical world of a durable, small-diameter vascular graft. This is enabled by a surprising discovery that the company’s material provides temporary support, to allow tissue to penetrate and develop within a porous polymer matrix, but then disrupts without significant inflammation to allow environmental conditioning.
It has been shown that pulsatile pressure triggers constructive remodeling, which results in transformation of developing tissues into structures that resemble natural blood vessels. This transformation will lead to a stable, self-supportive structure that will behave like a native blood vessel.
Other tissue-engineered approaches to this problem show promise in clinical tests but are produced using very complex and inherently expensive processes. Neograft’s technology functions via a similar mechanism of action but is much simpler and more economical to produce, so it will have comparable outcomes to these more complex product but capable to outpace them economically.
Neograft Technology’s Assets
Neograft has developed a portfolio of assets that are critical to developing, producing or marketing its proprietary regenerative vascular graft or similar constructs. In addition, our intellectual property related to venous reinforcement has significant potential as a barrier to competitive activity in this area. Our assets comprise:
- Patents, Patent Applications and Trademarks
- Significant intellectual capital, know-how and expertise in the development and testing of vascularimplants.
- An extensive database of in vitro and in vivo testing, including over thirty animal implantexperiments, on over 200 implants for up to 2 years.
- Clinical data from two clinical feasibility studies, one publication, and two manuscripts.
- Fixed assets of approximately $200,000 including a 500 square foot portable cleanroom, multiple chemical fume hoods, two viscometers, two tensile testers, a portable SEM with vapor and sputter coating system, GPC system, UV and IR spectrophotometer, numerous vacuum and environmental ovens, multiple autoclave systems, large variety of standard and specialty chemical glassware, a high density slide scanner, a variety of optical microscopes and camera systems, a specialty machine shop, a large number of handheld measurement tools and instruments.
The assets of Neograft Technologies will be sold in whole or in part (collectively, the “Neograft Technologies Assets”). The sale of these assets is being conducted with the cooperation of Neograft Technologies. Neograft Technologies and its consultants will be available to assist purchasers with due diligence and a prompt, efficient transition to new ownership.
Neograft Technologies, Inc. Key Personnel
Jon McGrath — President and CEO/Board Member: Jon has led the company since 2011. Prior to Neograft, Jon was CEO of LumeRx, a venture-backed gastroenterology startup,VP of R&D and Operations at Biosphere Medical(acquired by Merrit Medical);VP of R&D and Operations at Urologix (ULGX), and VP of R&D at Pfizer/Schneider (acquired by Boston Scientific). He cofounded Harbor Medical (acquired by Teleflex) and held several positions of increasing responsibility at Medi Tech (now BostonScientific).
Mohammed El-Kurdi— Chief Technology Officer: Dr. El-Kurdi co-founded the company in 2009. He has been focused on bioengineering arterial vein grafts since 2000, beginning shortly after he joined a cardiovascular research team at the University of Pittsburgh’s McGowan Institute for Regenerative Medicine. His PhD work focused on Neograft’s core technology that formed the foundation of the company and its central intellectual property. This work also resulted in the first peer reviewed publication of the product. Several generations later, the company has evolved a product that delivers on the promise of his early research to produce a stable and self-supporting arterial veingraft
Neograft Technologies, Inc. Board of Directors
Christopher S. Petersen, Chairman of the Board– Chris is president of RePetersen Enterprises, LLC., is Board Chairman at WeSpeke, Inc, and also serves on the Board of Directors for Medrobotics and Rinovum. Earlier professional experience includes KPMG, LLP and ThyssenKrupp, where he was Assistant Corporate Controller.
Jon McGrath, President and Chief Executive Officer- Earlier, Jon was CEO of LumeRx, VP of R&D and Operations at Biosphere Medical; VP of R&D and Operations at Urologix, and VP of R&D at Pfizer/Schneider. He cofounded Harbor Medical (acquired by Teleflex) and held several positions of increasing responsibility at Medi Tech (now Boston Scientific).
Thomas M. Dugan, MD- Tom is a retired cardiologist and a former president of a large cardiology and cardiovascular surgery private practice group in Erie, PA. He trained at Duke University, Georgetown University and the University of Pittsburgh. He is currently on the Board of Medrobotics.
Brad R. Petersen, PhD- Brad is currently a Pharmacy Operations Manager at Ohio Health’s Grant Medical Center. He is also on the Board of WeSpeke, Rinovum and Medrobotics.
Richard C. Petersen Jr.- Mr. Petersen is founder and President of Petersen Jr. Enterprises. He spent 32 years with GM/DELPHI, retiring as General Director of Corporate Planning for Delphi-Steering. He is also the Chairman of the Board for Rinovum Women’s Health LLC, and WeSpeke. He is a Director for a number of other entities that vary based on investments from time to time.
Michael Tovian- Michael (“Mike”) Tovian is Executive Consultant of Dosepoint LLC. Previously, he was President and CEO of Harmony Pharmacy and Health Center, served as Managing Director of Healthios Global, Inc., and spent 28-years prior to that with Walgreen Drug Stores, Inc, including as Vice President of Managed Care Sales and Contracting.
The Bidding Process for Interested Buyers
Interested and qualified parties will be expected to sign a non disclosure 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 Neograft Technologies 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 Neograft Technologies, 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 Neograft Technologies 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 Neograft Technologies Assets. Sealed bids must be submitted so that the bid is actually received by Gerbsman Partners no later than February 28 at 6:00 pm Eastern Standard Time (the “Bid Deadline”) at Neograft Technologies’s office, located at 470 Constitution Dr., Taunton, MA 02780. 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 Neograft Technologies fixed asset list may not be complete and Bidders interested in the Neograft Technologies’s Assets must submit a separate bid for such assets. Be specific as to the assetsdesired.
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 Neograft Technologies, Inc.). The winning bidder will be notified within 3 business days after the Bid Deadline. Non-successful bidder will have their deposit returned to them.
Neograft Technologies reserves the right to, in its sole discretion, to accept or reject any bid or withdraw any or all assets from sale. Interested parties should understand that it is expected that the highest bid will be chosen as the winning bidder and bidders may not have the opportunity to improve their bids after submission.
Neograft Technologies will require the successful bidder to close within 7 business days. Any or all of the assets of Neograft Technologies 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 Neograft Technology Assets shall be the sole responsibility of the successful bidder and shall be paid to Neograft Technologies at the closing of each transaction.
For additional information, please see below and/or contact:
Steven R. Gerbsman
steve@gerbsmanpartners.com
Kenneth Hardesty
ken@gerbsmanpartners.com
Read Full Post »