Osprey Medical

Advanced Kidney Protection During Coronary InterventionsOsprey Medical is a medical device company incorporated in 2005 with operations based Eden Prairie, Minnesota, USA. The Company is focused on the development and commercialization of its propriety CINCOR™ System designed for the prevention of Contrast Induced Nephropathy (CIN). The CINCOR™ System originated from technology developed at the Baker Heart and Diabetes Institute in Melbourne, Australia.

Overview
Osprey Medical has been funded to date by Australian institutional funds managed by CM Capital Investments, Brisbane and Brandon Capital Partners, Melbourne and other Australian sophisticated or professional investors.

Following successful clinical trials across 6 sites in Australia, New Zealand and Europe, Osprey Medical obtained CE Mark and plans to commence a controlled market launch of the CINCOR™ System in Europe in 2012.

Osprey Medical has also obtained approval from the FDA in the US to conduct a registration-directed pivotal trial which is planned in 2012 and aims to obtain FDA approval to enable a US market launch of the CINCOR™ System in 2014.

Osprey Medical’s Board and Management is comprised of experienced and successful personnel with established track records covering medical device development, regulatory approvals, sales and marketing, and mergers acquisitions. Osprey Medical’s advisory board comprises world-recognised experts in heart and kidney disease.

CIN: A Large Addressable Market Opportunity
At least 3.5 million angioplasty and stenting procedures are undertaken globally each year. In just the US and Western Europe alone, approximately 2.2 million patients undergo angioplasty and stenting each year.

Osprey Medical plans to first target the CINCOR™ System in patients with chronic kidney disease and whose anatomy is suitable for dye capture, representing approximately 400,000 patients per year in the US and Western Europe.

Based on a price of US$1,500-US$2,000 per procedure in the US and Western Europe, the immediate CINCOR™ System market opportunity is estimated to be approximately US$600-US$800 million per annum. Additional large market opportunities exist in the rest of the world including Japan, Asia, and Latin America.

Highlights

* The CINCOR™ System is designed to capture dye from the heart before it can enter the kidneys and cause damage (CIN).

* There is a clear market need and a large addressable market opportunity for the CINCOR™ System.

* The CINCOR™ System has limited competition.

* CIN is costly to hospitals and payers.

* The CINCOR™ System has demonstrated safety, simplicity, and efficacy in clinical trials to date.

* The CINCOR™ System has obtained CE Mark and a controlled market launch is planned for Europe.

* The CINCOR™ System has obtained FDA approval in the US to conduct a registration-directed clinical trial.

* Osprey Medical is aiming to complete its pivotal trial and obtain FDA clearance in 2014.

* Osprey Medical has an extensive patent portfolio.

* There is strong industry acquisition demand for medical device technologies, products and companies.

* Osprey Medical has strong support from specialist Australian Institutional Investors.

* Osprey Medical has experienced board, management and advisors.

Management Team

MIKE McCORMICK - President & CEO
Mike McCormick was appointed President & CEO of Osprey Medical in March 2010. Mike has more than 20 years of experience in the medical device industry and president level experience with public and private medical device companies.

From 2003 to 2008, Mike was President and CEO of Anulex Technologies, Inc., a private company focused on developing proprietary technologies to support the healing of spinal soft tissues. Prior to this, Mike was President of Centerpulse Spine-Tech, a publicly traded full-line supplier of innovative spinal technologies with over 400 employees and US$125 million in annual revenues. Mike was involved in the successful sale of Centerpulse Inc. to Zimmer in 2003 for US$3.2 billion.

Early in his career, Mike worked at Boston Scientific Scimed for 10 years and Baxter Health Care where he served in a variety of sales and sales management roles. Mike received his Bachelor of Business Administration, Business Management from the University of Texas at Austin.

Mike is Chairman of the Board at OrthoCor Medical, Inc. a commercial stage private company in Minnesota and, is a member of the Board of Directors of Formae, Inc. a private company in the orthopaedics space.

RODNEY HOUFBURG - Vice President of Research & Development
Rod joined Osprey Medical in July 2010. Rod has over 18 years of experience in the research and development of medical devices. Prior to joining Osprey Medical, Rod served as Vice President of Research and Development for Anulex Technologies, a venture-capital backed spinal device company. Prior to Anulex Technologies, Rod served as Director of Product Development for Centerpulse Spine-Tech (now Zimmer Spine) and developed orthopedic products at Wright Medical Technology. Prior to entering the medical device field, he developed smart weapons at Alliant Techsystems.

Rod is the inventor or co-inventor on 10 issued patents and seven pending patents and is co-author on multiple medical device publications. He received a Bachelor of Mechanical Engineering from the University of Minnesota.

MIKE LARSON - Director of Operations & Quality
Mike joined Osprey in September 2010. Mike has over 25 years of experience in quality and manufacturing including 14 years in the medical device industry. Prior to joining Osprey, Mike was Quality and Regulatory Affairs Manager for Alexandria Research Technologies, a privately held orthopedic medical device company, where he was instrumental in gaining 510(k) clearance for two unicompartmental knee products. Mike has also held key quality and/or manufacturing positions with Enpath Medical, Anulex Technologies, ev3 and Centerpulse Spine-Tech (now Zimmer Spine).

Mike has extensive experience in setting up ISO 13485 and cGMP compliant quality systems, as well as developing supplier qualification and management programs. He also is experienced in regulatory compliance and complaint handling. Previous to his career in quality and manufacturing, Mike served in the US Navy for 16 years as a Non-commissioned Officer.

DAN MANS - Vice President of Clinical & Regulatory Affairs
Dan joined Osprey Medical in August of 2011. He has more than 20 years of experience in the medical device industry and has held senior executive level positions in both publicly held and private companies. Prior to joining Osprey Medical, Dan co-founded Voyageur Medical, a firm devoted to helping companies identify and resolve vital project uncertainties in the earliest stage of product development. From 2006 through 2009, Dan led Corporate Clinical, Regulatory and R&D functions for American Medical Systems, a global leader in pelvic heath. Early in his career, Dan worked for several successful start-up companies and at Medtronic where he held various clinical research and management positions.

Dan has contributed to over 25 product development teams producing products in electrophysiology, cardiac surgery, spinal orthopedics, urology and gynecology. He has testified twice before FDA advisory panels, both times gaining unanimous recommendation for approval for first-of-a-kind PMA devices. He has conducted clinical research and garnered product approvals in the US, Canada, Europe and Asia. Dan obtained a Bachelor of Science in Mechanical Engineering and graduate training in Biomedical Engineering, both from the University of Minnesota.

NANCY NESS - Vice President of Finance
Nancy joined Osprey Medical in May 2010 as acting Vice President of Finance. She currently serves as a Board Member and founder of Vatrix Medical and as an active chief financial officer for several medical device companies. Nancy has been providing key financial and fundraising services to over 28 medical device start-up companies in Minnesota, New York, and California. Nancy has also served in various financial positions for Anulex Technologies, Northwest Airlines (Delta) and Home Styles Publishing and Marketing, prior to focusing solely on the medical device and bio-pharma markets. In addition, Nancy spent five years as a certified public accountant. Nancy has more than 27 years of experience in the financial community.
Nancy has a B.A. in Accounting and Business Administration from the University of St. Thomas and a Certified Public Accountant license in 1984.

DOUG SCHOENBERG - Vice President Marketing, Education & Reimbursement
Doug joined Osprey Medical in April 2010. Doug has more than 14 years of experience in marketing in the medical device industry. From 2005 to 2009, Doug was Vice President of Marketing for Anulex Technologies, a venture-capital backed spinal device company. Doug was responsible for building Anulex's marketing, training, and reimbursement organization to commercialize two FDA 510(k) cleared products in a new market segment. He has also served in various marketing roles for St. Jude Medical, Zimmer Spine, and Schneider/Namic (now part of Boston Scientific).

Doug holds a B.A. from St. Cloud State University and an M.B.A in Marketing from the University of Minnesota. He also has co-authored a medical journal publication in the area of health economics

Board of Directors

JOHN ERB - Non-Executive Chairman
John Erb has 35 years of experience in the medical device industry.

John is currently Chairman of the Board of Vascular Solutions, Inc., a NASDAQ listed company and has served on this board for 8 years. Vascular Solutions manufactures medical devices for the cardiology and interventional radiology markets and has annual revenue of approximately US$100 million.

John previously served 8 years on the Board of Directors of CryoCath Technologies, Inc., a public company listed on the Toronto stock exchange. CryoCath Technologies developed, manufactured and distributed products to the electrophysiology cardiologist for the treatment of atrial fibrillation. CryoCath Technologies was acquired by Medtronic for US$350 million in 2008. John also served 8 years on the Board of Directors of SenoRx, Inc., a NASDAQ listed company. SenoRx developed, manufactured and distributed products used by oncologists treating breast cancer. SenoRx was acquired by C. R. Bard for US$250 million in 2010.

In 2007, John was Executive Chairman of the Board for CHF Solutions, Inc., a medical device company involved in the treatment of congestive heart failure. From 2001 to 2006, John was Chief Executive Officer of CHF Solutions. CHF Solutions was acquired by Gambro in 2010. From 1997 to 2001, John was President and Chief Executive Officer of IntraTherapeutics, Inc., a medical device company involved in the development, manufacturing, and distribution of peripheral vascular stents. IntraTherapeutics was acquired by Sulzer Medica for US$150 million in 2001. Previously, John was Vice President of Operations for Schneider Worldwide, a division of Pfizer, Inc. John spent 10 years with Johnson & Johnson's Iolab Division and started his career with American Hospital Supply Corporation.

John is currently on the Board of Directors of Jan Medical, a venture capital finance start-up focused on stroke. John has a bachelor's degree in business administration from California State University, Fullerton. John currently is the Chairman and Chief Executive Officer of Cardia Access, Inc., a start-up medical device company focused on innovative technologies for pacing the heart.

MARK HARVEY, Ph.D. - Non-Executive Director
Mark is a Partner and Director of CM Capital Investments. He has over 15 years experience in medical research, technology transfer and commercialization and has played key roles in the formation, fund raising, and management of numerous life science companies. He is currently on the Board of Directors of Sunshine Heart, Inc. (ASX:SHC), a medical device company developing a treatment for heart failure, and Pathway Therapeutics Inc., a clinical-stage company developing a small molecule, kinase inhibitor.

Prior to joining CM Capital Investments, Mark was the Managing Director of Symbiosis Group Limited, an early stage life sciences investment company, and was Group Manager, Life Sciences for UniQuest, the main commercialization company for the University of Queensland. Mark was also a member of the Investment Committee of UniSeed, a $60 million fund focusing on developing technologies from the University of Melbourne and the University of Queensland.

Mark has a PhD (Physiology) and a MBA, and is Adjunct Associate Professor of the University of Queensland.

CHRIS NAVE, Ph.D. - Non-Executive Director
Chris Nave is a founding partner of Brandon Capital Partners and Principal Executive of the Medical Research Commercialization Fund. Chris previously was Director of Commercialization at the Baker IDI Heart and Diabetes Institute, Melbourne Australia, where he was responsible for the commercialization of technologies developed at the Baker and the Alfred Hospital.

Prior to this, Chris was the Manager of the Biotechnology Team at Melbourne Ventures, the commercialization company of the University of Melbourne. Concurrently during this period, he was an investment manager for, and on the investment committee of, UniSeed Pty Limited. Chris has international business development experience with Leiras Pharmaceuticals in Finland, a wholly owned subsidiary of Schering AG.

Chris is currently a Director of Spinifex Pharmaceuticals, Fibrotech Therapeutics, and BACE Therapeutics. Chris has a first-class Honors degree in Science and PhD in Endocrinology and Physiology from the University of Melbourne. He recently completed the Private Equity and Venture Executive Program at Harvard Business School (Boston USA) and is completing a Graduate Diploma in Intellectual Property Law at the University of Melbourne. Chris a graduate of the Australian Institute of Company Directors. He is a member of Ausbiotech and the BioMelbourne Network.

Medical Advisors

Steve Bailey, MD
Dr Bailey is practicing interventional cardiologist. He is Professor of Medicine and Chief of Cardiology at the University of Texas Health Science Center in San Antonio. He teaches students, residents and fellows, and conducts research on many interventional cardiology related topics. Dr Bailey is past president of the Society for Cardiovascular Angiography and Interventions (SCAI) which is a professional organization for invasive and interventional cardiologists. He is board certified in internal medicine and cardiovascular disease.

David Kaye, MD
Dr Kaye is a practicing cardiologist, specializing in the areas of heart failure and transplantation. He is Head of the Cardiology and Therapeutics Division at the Baker Heart and Diabetes Institute in Melbourne, the largest cardiovascular research centre in Australia. The Company's core technology was developed by Dr Kaye and Dr John Power in their Heart Failure Research Group. Dr Kaye is known internationally for his work on the causes of heart failure and for the development of novel medical devices to treat cardiovascular diseases.

David Lee, MD
Dr Lee is a practicing interventional cardiologist. He is an Associate Professor of Cardiovascular Medicine and Director of Coronary Interventions and Cardiac Catheterization at Stanford University Hospital in California. His major research interests include new treatment strategies and delivery of care in STEMI, and device-based management of structural heart disease. Dr. Lee has published numerous cardiovascular research studies.

Gregg Stone, MD
Dr Stone is a practicing interventional cardiologist. He is Professor of Medicine and the Director of Cardiovascular Research and Education at New York-Presbyterian Hospital/Columbia University Medical Center, one of the most comprehensive university hospitals in the world with leading specialists in every field of medicine. He is the Co-Director of Transcatheter Cardiovascular Therapeutics (TCT), the world’s largest symposium on interventional cardiology and vascular medicine. Dr. Stone has served as the principal investigator for more than 60 national and international multicenter randomized clinical trials.

James Tumlin, MD
Dr. Tumlin is a practicing Nephrologist. He is Professor of Medicine at the University of Tennessee in Chattanooga. He is also the founder and Medical Director of the Southeast Renal Research Institute. He is widely acknowledged as a thought leader in acute kidney injury. He has conducted over 20 years of clinical research and has published numerous studies on contrast induced nephropathy. He is on the editorial board of the Journal of the American Society of Nephrology and reviews manuscripts for multiple medical journals.
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CIN: CONTRAST INDUCED NEPHROPATHY

What Is CIN?

Contrast Induced Nephropathy (CIN) is a form of kidney damage caused by the toxic effects of dyes (known as 'contrast media') used by cardiologists to x-ray the heart and blood vessels during commonly performed heart procedures such as angioplasty and stenting. The dye is toxic and can reduce the blood flow in kidneys which can lead to serious patient complications.

The dye can generally be tolerated in patients with normal kidney function. However, patients with poor or non-functioning kidneys may suffer from rapidly declining health, poor quality of life, and significantly shortened life expectancy.

Potential Consequences of CIN:
- Irreversible damage to the kidneys
- Longer hospitalization
- Increased risk of heart disease
- Long-term dialysis
- Rapidly declining health
- High risk of death

(Click here to watch how dye enters the kidney during a heart procedure)

Who's at Risk?

Patients that have compromised kidney function are at the highest risk of having a CIN event from heart procedures such as angioplasty or stenting. Typically, these are patients who, in addition to their heart problems, also suffer from either:

- Chronic kidney disease; or
- Diabetes

It is generally believed that a compromised kidney is less able to tolerate the toxic dyes and is slower in flushing toxic dye through the kidneys. As a result, the dye spends more time in the kidneys and has a greater chance of causing further kidney damage.

How is CIN Diagnosed?

Due to the toxic effect of dyes on the kidneys, cardiologists routinely assess patients' kidney function prior to conducting a heart procedure.

Kidney function is commonly assessed by a standard blood test, which measures the amount of substance known as serum creatinine, present within the blood. Serum creatinine is a waste product of the muscles of the body which, in a healthy individual, is filtered out of the body by the kidneys. Higher levels of serum creatinine in the blood indicate reduced functionality of a patient's kidneys.

The US National Kidney Foundation defines the five stages of kidney disease. These stages are determined primarily by serum creatinine measures.

What are the Outcomes of CIN?

High Risk of Death

Patients who acquire CIN can have an increased risk of death (mortality) before leaving the hospital after a heart procedure such as angioplasty or stenting. If CIN patients survive their hospital stay, their risk of dying remains high within a year of their heart procedure and is even higher within 5 years of their procedure.

High Cost to Health Providers

CIN has significant economic burden. The average additional length of stay in the hospital is 4 days and patients requiring dialysis can require much longer hospitalization. For patients surviving CIN, there is an increased risk of on-going heart and kidney problems, creating an added economic burden.

Can CIN be Treated?

It is generally accepted that there currently is no treatment available to reverse or improve damage to the kidneys, once a patient develops CIN. Once CIN develops, patients often stay in the hospital several additional days so fluid levels, kidney function, and potential complications can be monitored until their serum creatinine levels in the blood return to more normal levels. Even if serum creatinine levels return to more normal levels following CIN, patients may be at higher risk for accelerated kidney disease progression, future cardiovascular complications, and death after leaving the hospital.

Can CIN be Prevented?

Due to a lack of viable treatment options for CIN, cardiologists currently use preventative strategies including hydration and dye (contrast) management. However, to date, these strategies have had limited impact on reducing the frequency of CIN events. The table below describes the most common preventative strategies.

The CINCOR™ Contrast Removal System is designed to provide cardiologists with an advanced level of CIN protection in high risk patients undergoing heart procedures such as angioplasty and stenting.

The CINCOR™ System is a catheter and vacuum system that is designed to directly capture and remove a significant quantity of the dye as it leaves the coronary sinus (the heart's main drainage vein) before it makes its way to the kidneys. The CINCOR™ System can be activated multiple times throughout the heart procedure. At the conclusion of the procedure, the small amount of dye-laden blood is discarded.

Information in this post was sourced from these links:
CINCOR™
CINCOR™ Pivotal Trial
Media Sheet
Osprey Medical