SALE OF ALURE MEDICAL, INC.
Gerbsman Partners (www.gerbsmanpartners.com) has been retained by Alure Medical, Inc. (www.AlureMedical.com) to solicit interest for the acquisition of all, or substantially all of, Alure Medical’s assets.
Headquartered in Santa Rosa, California, Alure Medical is a medical device company developing innovative product for minimally invasivecosmetic and reconstructive procedures. Allure’s technology provides applications to various parts of the body, including breasts, buttocks, thighs, etc.
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 Alure Medical’s Assets (as defined herein) has been supplied by Alure Medical. It has not been independently investigated or verified by Gerbsman Partners or their respective agents.
Potential 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 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.
Gerbsman Partners, and their respective staff, agents, and attorneys, (i) disclaim any and all implied warranties concerning the truth, accuracy, andcompleteness 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 Alure Medical’s or Gerbsman Partners’ negligence or otherwise.
Any sale of the Alure Medical Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either expressed orimplied, of any kind, nature, or type whatsoever from, or on behalf of Alure Medical and Gerbsman Partners. Without limiting the generality of the foregoing, Alure Medical and Gerbsman Partners and their respective staff, agents, andattorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the Alure Medical Assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, theimplied 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. Thismemorandum and the information contained herein are subject to the Confidential Disclosure Agreement attached hereto as Appendix A.
Alure Medical, Inc., a Santa Rosa, California based medical device company, develops innovative products for minimally invasive cosmetic and reconstructive procedures. The company’s main product is the minimally invasive internal suspension systems that support soft tissue naturally from within. The company has one (1) issued U.S. patent (Nov 2010), four (4) pending U.S. patent applications, and three (3) pending foreign PCT applications.
Alure Medical was founded in 2007 and has raised $5.5 million in capital financing. Alure Medical’s mission is to develop minimally invasive solutions for enhancing cosmetic and reconstructive procedures. The body changes significantly during one’s lifetime and many are seeking for ways to correct or regain a youthful, aesthetic appearance. Most options are invasive surgeries, while other options have limited effectiveness.
Everyone is affected by ptosis (drooping/sagging) which is part of the natural aging process. Ptosis is often exaggerated after child birth and other weight fluctuations. Others have asymmetry due to genetics or previous procedures like mastectomies or otherbreast reconstruction. The Alure technology provides a unique and elegant approach to aesthetic procedures in an effective, minimally invasive system.
The core of Alure Medical’s technology is the Alure Medical RefineTM device. The device kit consists of two sets of implantable mesh and sutures lines. In addition, the kit comes with two delivery needles and a handle that will aid the physician in delivering the implantable components. The product is packaged and delivered sterilized via e-beam radiation. The system has proven to be an effective, easy-to-learn, and easy-to-use product for patients who desire a change to their breast shape and position. The product has not been tested in other areas of the body but a high level of interest has been communicated to thecompany. These new areas include buttocks, thighs, and other soft tissue areas that are troublesome for patients and their physicians.
AVIDEO IS AVAILABLE DESCRIBING THE ALURE MEDICAL REFINE DEVICE UPON REQUEST WITH A SIGNED NON-DISCLOSURE AGREEMENT
Alure Medical believes its assets are attractive for a number of reasons:
· Alure Medical’s intellectual property based on Minimally Invasive Tissue Support and Non Augmentative Mastopexy, includes one (1) issued U.S. patent (Nov 2010), four (4) pending U.S. patent applications, and three (3) pending foreign applications in each of Australia, Canada, and Europe.
· US FDA 510(k) clearances 2009 (K08312) and 2010 (K092538): The Refine™ Support System is indicated for reinforcement of soft tissue in plastic or reconstructive procedures.
· CE Mark 2008: The Refine™ Lift System is indicated for use in the approximation of soft tissue including, but not limited to the breast, mid-face, forehead, neck, jowls, and buttocks.
· Alure Medical is being sold in US and Europe.
· Longest term Alure cases now implanted 3.5+ years.
· Alure Medical implant procedures exceed 100+ cases to date.
· Three (3) internationally renowned plastic surgeons have actively supported, implanted, and purchased Alure Medical’s devices.
· Alure Medical has sold over 60 units with an ASP of $800+, for a kit.
· Two US surgical sites have reimbursement approval (hospital pay).
· Recent sites have paid training fees of $500 each.
· Alure Medical has achieved ISO 13485 certification.
· Alure Medical has received California FDB (Food and Drug Branch) approval.
· Alure Medical is vertically integrated with the majority of the assembly in-house and easily scalable.
· Alure Medical believes suspension technology is applicable forother markets inside the plastic surgery field, and also applies into non-surgical cosmetic field and other non-cosmetic clinical procedures, such as wound therapy.
Impact of Technology on the Market
Many procedures performed by plastic surgeons are limited by their tools of scalpels, sutures, and augmentation implants. There is a universal desire from physicians and patients to achieve aesthetic results with the minimal amount of noticeable scarring, while maintaining a natural appearance. A clinical need exists for a specialized device to help reinforce, support, and manipulate soft tissue from small entry sites.
Specific to the breast surgery field, physicians and patients desire a minimally invasive method of performing mastopexy that allows faster recovery and less post-operative pain as compared to traditional surgical methods. Market research indicates that approximately 90,000 traditional mastopexy procedures, 80,000 breast reductions, and 300,000 breast augmentation surgeries are performed each year in the US alone. In the US, there are also about 4,000,000 previous breast implant patients, and 1,000,000 previous breast lift patients. Feedback demonstrates there is also a potentially large “new market” of patients that are dissatisfied with their body, but do nothing. Many know their options are invasive surgery or breast implants, which are not acceptable. The company estimates that there could be 7,500,000 “new market” patients in the US alone that would consider using this technology. Considering all theprocedures numbers above, the global market is estimated as 2X the size of the US market.
Physician feedback indicates that a significant percentage of their cases would utilize the Alure device instead of their surgical procedure and would also use thedevice in conjunction (adjunctively) with their surgical procedure. The previous breast surgery patients may also want a quicker, less obtrusive revision to refresh their look. Within a few years, this minimally invasive option is expected to capture 100,000 procedures per year, when penetrationreaches 0.5% of the market. This conservative 0.5% penetration would equate to $60,000,000 dollars in global sales.
Intellectual Property Summary
1. Alure Medical’s intellectual property based on Minimally Invasive Tissue Support and Non Augmentative Mastopexy, includes one (1) issued U.S. patent (Nov 2010), four (4) pending U.S. patent applications, and three (3) pending foreign applications in each of Australia, Canada, and Europe, each as more specifically described in Intellectual Property section. The portfolio represents a broad array of strategic variables including:
2. Alure IP covers an internal suspension implantation system for performing a breast tissue lift.
3. Alure issued IP uniquely has an upper fixation mesh and lower soft tissue anchors. This is comparison to other lower sling “internal bra”, concepts, that have not proven effective via a minimally invasive approach.
4. Alure issued IP covers fixation points in soft tissue. This creates natural look and a natural suspension. This is compared to the disadvantages of fixing into rigid clavicle or ribs.
5. Alure IP generated around post implanted adjustability mechanisms- able to adjust and correct a device that has been previously implanted.
6. Alure IP generated around durable and bioabsorbable internal suspension components.
7. Alure IP generated on a variety of other internal suspension concepts.
Alure Medical’s Assets
Alure Medical has developed a technology portfolio that delivers a product platform for adjunct and stand-alone use in cosmetic and reconstruction procedures. It is a simple technology that physicians are creatively expanding to new indications. These assets fall into a variety of categories, including:
· Patents, patent applications, and trademarks
· Regulatory approvals in US and Europe
· Technology addressing in the billion dollar market of aesthetics
· Established customer revenue with surgeon/patient sales
· Established hospital pay
· The only minimally invasive internal fixation system that works
· Positive long term clinical feedback from top surgeons and their patients
· Next generation product designs
· Manufacturing and equipment developed internally and easily scalable
· Intellectual capital and expertise
The assets of Alure Medical will be sold in whole or in part (collectively, the “AlureMedical Assets”). The sale of these assets is being conducted with the cooperation of Alure Medical. Alure Medical and its employees will be available to assist purchasers with due diligence and a prompt, efficient transition to new ownership. Notwithstanding the foregoing, Alure Medical should not be contacted directly without the prior consent of Gerbsman Partners.
Michael J. Lee
VP of Research and Development
Head of Operations
Mr. Lee has headed Alure R&D and Operations since April 2009. He has more than 18 years of medical device experience. Prior to Alure, Mr. Lee headed Medlogics, a drug eluting coatings and stent company, in the areas of R&D, Engineering, Equipment, and Facilities since August 2003. Prior to Medlogics, Mr. Lee was the Director of R&D of Bioheart’s hybrid percutaneous, thoracoscopic, and surgical myocardial regeneration injection systems, where he started and headed the delivery system division. Prior to Bioheart, Mr. Lee was in R&D for Cardeon Corporation, responsible for research and development of innovative blood return cannulae with cerebral protection using differential flow and temperature. Prior to Cardeon, he was in R&D for Arterial Vascular Engineering, Inc. (subsequently acquired by Medtronic, Inc) working on stents, stent delivery systems and angioplasty devices for coronary and peripheral indications; and was instrumental in the growth from about 30 to 3000 employees over 4 years. Prior to AVE, he worked in R&D at Cardiac Pathways Corporation (subsequently acquired by Boston Scientific Corp.) on innovative electrophysiology systems with integrated cooling. Mr. Lee has several patents issued and several that are pending. He has a B.S. in Mechanical Engineering from California Polytechnic State University, San Luis Obispo.
Board of Directors
Mr. Lashinski is a co-founder of Alure Medical, served as President and CEO, and currently is Chairman of the Board. Mr. Lashinski is currently Claret Medical’s President and CEO. Mr. Lashinski was also a co-founder of Direct Flow Medical a percutaneous aortic valve replacement company. Acting as the CEO for Direct Flow’s first two years he raised $8.5 million in funding to achieve clinical use of the product which is now in a European Clinical Trial. Mr. Lashinski also was a founding engineer and served on the board of directors at MitraLife where he helped develop a device based treatment for congestive heart failure. The company was sold to EV3 in Minneapolis in 2003. Prior to this was he VP of R&D at Medtronic Vascular (AVE). This division was spawned from the $4.3 billion dollar acquisition of AVE where Mr. Lashinski held other roles in Engineering and Management. Mr. Lashinski was also employed as an R&D engineer atTarget Therapeutics which was acquired by Boston Scientific in 1999 for $1.1 billion dollars. Mr. Lashinski received his education from the University of Minnesota in Mechanical Engineering.
Mr. Bishop co-founded Alure in 2007. A serial entrepreneur Mr. Bishop also co-founded Direct Flow Medical in June 2004. Mr. Bishop was recruited to Arterial Vascular Engineering, Inc. (AVE) in 1999 where he lead various stent projects including the Driver™ stent currently on the market in the US and Europe. In addition to leading the Driver stent Project at AVE, Mr. Bishop served on the ASTM F04 committee alongside agents of the FDA and other industry representatives to establish standards for stenttesting and modeling. Hired as a Senior Engineer at MitraLife, Inc,. Mr. Bishop was a lead engineer on a novel percutaneous approach to lessen mitral regurgitation by implanting a deviceinto the coronary sinus. MitraLife was acquired by ev3, Inc. a Minneapolis based company. Mr. Bishop has a B.S. degree in Mechanical Engineering from California Polytechnic State.
Mike is a Managing Director with EDF Ventures. Mike’s 25-year medical device background, coupled with his experience with venture-backed companies, gives him a valuable perspective in guiding start-ups in the medical device industry. Currently, Mike sits on the boards of the following companies: Alure Medical, BioSurface Engineering Technologies, and CardioMetrix. He serves as Chairman of the board for the following companies: Direct Flow Medical, Sonoma Orthopedic Products, and TransCorp, Inc. Prior to joining EDF, Mike served as President and CEO of A-Med Systems, a California-based cardiac device company. Prior to A-Med, Mike served on theexecutive team of Medtronic’s venture organization focused on cardiac surgery technology. His background also includes serving on the management team at DLP, a Michigan-based cardiac device company which was acquired by Medtronic. Mike holds an MBA from Grand Valley State University and a BA from Calvin College. In addition, Mike is a Kauffman Fellow.
Mr. Condon has been President and Chief Business Officer of Merz Aesthetics since June 2007 and served as a board of director from January 2004 to June 2007. From March 2006 to June 2007, he was the Chief Executive Officer and President of Apsara Medical, a medical device company focused on the aesthetics market. From February 2005 to November 2005, Mr. Condon was the President and Chief Executive Officer of Reliant Technologies Inc., a provider of lasers for aesthetic applications. Since November 2002, Mr. Condon has also served as a principal of a privately-held medical aesthetics services practice. From 1998 to July 2002, he was Chief Executive Officer of The Plastic Surgery Company, a healthcare services company. From 1991 to 1998, he was President of Mentor Corporation’s aesthetics division. Mr. Condon holds a B.S. from the University of California, Davis
Joshua Siegel, MD is the Sports Medicine Director at Access Sports Medicine & Orthopaedics in Exeter, NH. Dr. Siegel has pioneered techniques in arthroscopic surgical treatments of the knee, shoulder and elbow. He is a fellow of the American Board of Orthopaedic Surgeons, and a member of the American Orthopedic Society for Sports Medicine (AOSSM), the Arthroscopy Association of North America, and the Sports Medicine Fellowship Society. He is also a founding member of Northeast Surgical Care, an ambulatory surgery center in Newington, NH. He completed his sports medicine fellowship at the American Sports Medicine Institute in Birmingham, Alabama under Dr. James Andrews and Dr. William Clancy. He currently serves as a US Ski and Snowboard Team physician and is also serves as a physcian for the US Olympic Committee. He has won numerous awards for medical and business accomplishments nationally and statewide.
Scientific Advisory Board
Jack Fisher, M.D.
Dr. Fisher is currently the Treasurer of The American Society for Aesthetic Plastic Surgery (ASAPS), and will be President of the Society in 2013. Dr. Fisher is a distinguished member of the American Board of Plastic Surgery (ABPS) and The American Society of Plastic Surgeons (ASPS). He also is currently on the ASAPS Board of Education Committee. Throughout the country, Dr. Jack Fisher is a well-known and respected surgeon. He has been invited to speak at a number of surgical conferences throughout the world particularly on breast and aesthetic surgery. He is also an Associate Clinical Professor of Plastic Surgery at the prestigious Vanderbilt University Medical Center in Nashville, TN. Dr. Fisher received his medical degree from the Emory University School of Medicine inAtlanta, completed his internships and residencies in general surgery at George Washington University Medical Center and his plastic surgery residency at Emory University Affiliated Hospital. Following his residency, he was on staff at the Mayo Clinic in Rochester, MN, from 1981 to 1986 as attending plastic surgeon.
Dennis Hammond, M.D.
ASAPS Chairman, Symposium Committee
James Namnoum, M.D.
Co-Chair of Atlanta Breast Symposium, (Top Global Breast Surgery Meeting)
The Bidding Process for Interested Buyers
Interested and qualified parties will be expected to sign a Confidential Disclosure Agreement (attached hereto as Appendix A) to have access to key members of management and intellectual capital teams and the due diligence “war room” documentation (“Due Diligence Access”), and the Alure Video. 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 had an opportunity to inspect and examine the Alure 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 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 Gerbsman Partners (and their respective staff, agents, or attorneys) do not make any representations as to the accuracy orcompleteness 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 Alure Medical Assets. Each sealed bid must be submitted so that it is received by Gerbsman Partners no later than Wednesday, November 2, 2011 at 2:00pm Pacific Daylight Time (the “Bid Deadline”) at Alure Medical’s office, located at 3637 Westwind Boulevard, Suite B, Santa Rosa, California 95403. Please also email firstname.lastname@example.org with any bid.
Bids should identify those assets being tendered for in a specific and identifiable way. In particular, please identify separately certain equipment or other fixed assets.
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. All bids must be accompanied by a refundable deposit in the amount of$200,000 (payable to Alure Medical, Inc.). The deposit should be wired to Alure Medical’s attorneys Wilson, Sonsini, Goodrich & Rosati. The winning bidder will be notified within 3 business days of the Bid Deadline. The deposit will be held in trust by Alure Medical’s counsel. Unsuccessful bidders will have their deposit returned to them within 3 business days of notification that they are an unsuccessful bidder.
Alure Medical reserves the right to, in its sole discretion, accept or reject any bid, or withdraw any or all assets from sale. Interested parties should understand that it is expected that the highest and best bid submitted will be chosen as the winning bidder and bidders may not have the opportunity to improve their bids after submission.
Alure Medical will require the successful bidder to close within a 7 day period. Any or all of the assets of Alure 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 Alure Medical Assets shall be the sole responsibility of the successful bidder and shall be paid to Alure Medical at the closing of each transaction.
For additional information, please see below and/or contact:
Steven R. Gerbsman