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Biophan Technologies, Inc. OTC: BIPH. Cautionary Statement.
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Biophan Technologies, Inc. OTC: BIPH
Cautionary Statement Certain statements included in this presentation may constitute forward-looking statements within the meaning of applicable securities laws. These statements reflect what Biophan anticipates, expects or believes may happen in the future. Biophan's actual results could differ materially from the outcome or circumstance expressed or implied by such forward looking statements as a result of a variety of factors including, but not limited to: Biophan's ability to develop its technologies; the approval of Biophan's patent applications; the successful implementation of Biophan's research and development programs; the ability of Biophan to demonstrate the effectiveness of its technology; the acceptance by the market of Biophan's technology and products incorporating such technology; the ability of Biophan to effectively negotiate and enter into contracts with medical device manufacturers for the licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its operating and research and development activities until it generates revenues sufficient to do so; and the timing of projects and trends in future operating performance, as well as other factors expressed from time to time in Biophan's periodic filings with the Securities and Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction with Biophan's periodic filings with the SEC which are incorporated herein by reference. The forward-looking statements contained herein are made only as of the date of this presentation, and Biophan undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
Description of Business A medical device company with two lines of business: • Commercialization of the MYOTECH CSS • A novel cardiac support system, with unique advantages in providing circulatory support and recovery in patients with acute heart failure • Revenue potential: approximately $4 Billion per annum • Time to clinical trials in humans: approximately 15 months • Time to market: approximately 24 months • Market can be direct to hospitals or through a distribution partner
The Expanded Marketplace • Currently, in the US, there are • 67 active destination therapy centers • 120 transplant centers • 960 specialized cardiac centers • And 6,800 hospitals • The Myotech CSS: • is technically simple to install • enables use in a much larger segment of the hospitals in the US • reaches the patientswhere they present, not only at the most advanced centers
Product Pipeline • First Generation Product – Acute Resuscitation • Support patients with acute heart failure from acute MI / cardiogenic shock or cardiac arrest • Total potential patient population > 300,000 per year in the US alone – 80% of whom do not survive with the current standard of care of CPR, defibrillation and drugs. • Addressable worldwide market of over $4.5 billion • Future growth from drug delivery, therapeutic recovery, military use, addressing chronic heart failure
Licensing of Enhancement Technologies • Licensing of technologies for MRI Safety and Image Compatibility for various medical devices • Making electrical devices safe for use with MRI – licensing on leads (selling off for infusion of capital • Making vascular implants visualizable under MRI, non-invasively (competing with angiograms and intravascular ultrasound), particularly for detecting restenosis and clotting in stents (licensed to Boston Scientific for 3% royalty on products that ship, potential for $60 million a year in revenue for Biophan)
The Market:Image Compatibility • Biophan’s revenue opportunity represents royalties (3 to 5%) on sales of products incorporating Biophan’s technology • Stents licensed to Boston Scientific for 3% royalty, potential from their deal is $60+ million per year to us, once on the market • Pacemaker and other devices use technology in leads, representing about 20% of the market. Offers were coming in for 1-2% royalty on leads, once product started shipping (2-3 years out, estimated) • We are selling the safety related patents and retaining the stent related patents for $11 million in cash to Medtronic, using the cash to develop the Myotech CSS product Sources: JP Morgan and Lehman Brothers
MRI Image Compatibility Without Biophan Technology With Biophan Technology Product Resonant Stent Blockage Stents Biophan technology allows doctors to non-invasively image stents to visualize thrombus or in-stent restenosis Vena Cava Filters Biophan technology allows doctors to non-invasively image vena cava filters to visualize thrombus
The Myotech Opportunity The Problem Acute heart failure (following massive heart attack or cardiac arrest) is one of the largest underserved markets in healthcare. • Existing Solutions • Each of the following approaches has significant limitations: • CPR / defibrillation • Traditional medical therapy • IABP (intra-aortic balloon pump) • VAD (ventricular assist device)
The Myotech Circulatory Support System Approach: Pump the heart without contacting circulating blood. How it Works • Polymer cup that slips over the heart • Installed via a small chest incision • Actuated by a small external driver • Sustains natural pulsatile flow • Avoids bleeding, clotting, infection This technology has already saved human lives.
The Myotech Advantage • No blood contact – minimizes the risk of clotting, stroke, bleeding and infection • Immediate resuscitation and support – installs in about 3 minutes • Can be installed by a general surgeon at most hospitals, not just specialized cardiac centers • Recovery and simple removal, or bridge to definitive therapy • Unique advantages for unserved/underserved patient populations, including women and children • Cost-effective
Biophan Developing 3rd Generation • First: 1970’s to 1980’s in animals, being perfected; 1990’s tried in humans and worked in early prototype form • Second: Developed by Cardiotech with modified design that ran into problems of retention and bruising the heart; company failed • Third: Recruited the original designers, Improved the original design, Developed a regulatory plan for a industrial strength design • Created a patent portfolio valued at $26 million, pre-revenue, to protect space for DMVA approach, plus drug delivery, new materials, therapeutic improvements, driver algorithms, much more
Myotech CSS Percutaneously Installed VADs Surgically Installed VADs Total Artificial Heart Features Competitive Comparison
Clinical and Pre-clinical ResultsUsing Early Prototypes 1.Supported 45-year old for 2 days following massive myocardial infarction. 2. Supported 71-year old for 2 days following otherwise successful open heart surgery. 3. Supported 56-year old for 2-1/2 days as a bridge to successful heart transplantation. 4. Supported 18-year old for 7-1/2 days until heart healed from a viral myocarditis. 5. Supported 44-year old for 84 days with normal neurologic function. All with no damage to the native heart or by-pass grafts More than 700 animal experimentsconducted to evolve and evaluate the technology (over wide spectrum of applications).
Intellectual Property Estate:The Myotech CSS • Patent Protection • Comprehensive U.S. applications • Foreign filings in process • Additional applications being prepared • Technologies / Inventions Covered • Operational features • Diagnostic capabilities • Therapeutic capabilities
Dr. James Lowe, Cardio-Thoracic SurgeryDuke University • Video of Dr. James Lowe speaking about need and market for Myotech • Dr. Lowe is on the Myotech Scientific Advisory Board
Scientific Advisory Board: MYOTECH Mark P. Anstadt, MD, FACS. Chairman Wright State University of Medicine – Assoc Professor of Cardiothoracic Surgery. Co-founder and co-inventor. William Holman, MD, FACC U of Alabama at Birmingham – Professor and Chief of CT Surgery, VA Hospital. VAD specialist. James Lowe, MD Duke University Medical Center– Professor of Cardiac Surgery and Pathology. Pioneered MYO-VAD™. Douglas Mann, MD, FACC, FACP Baylor College of Medicine – Professor, Chief of Cardiology. Leader on molecular basis of heart failure. Robert Michler, MD, Albert Einstein College of Medicine , Monefiore Med Ctr – Professor, Chief of CT Surgery. Min invasive expert. Carmelo Milano, MD Duke University – Assoc Professor and Surgical Director of Cardiac Transplantation and LVAD Programs. Anthony Perez-Tamayo MD, PhD Rush University Medical Center – Assistant Prof of Cardiac and Thoracic Surgery, Director of Research. Peer M. Portner, PhD, FACC, FAHA Stanford Univ School of Medicine– Consulting Prof of Cardiothoracic Surgery. World leader in VAD therapies Michael Sketch, MD Duke University Medical Center – Professor of Cardiology (Interventional). Benjamin Sun, MD Ohio State Univ Medical Center – Assoc Professor, Chief of Cardiothoracic Surgery, and Director of Cardiac Transplantation and Mechanical Support. Samuel Tisherman, MD U of Pittsburgh Medical Center – Professor of Surgery, Critical Care Specialist.
Management Michael L. Weiner President, Biophan Technologies; formerly with Xerox Corporation John Lanzafame Chief Operating Officer; formerly with Angiotech Robert Wood Chief Financial Officer Stuart MacDonald Vice-President, R&D; formerly with Johnson & Johnson Board of Directors Dr. Guenter H. Jaensch Chairman; former Chairman and CEO of St. Jude Pacesetter, Inc. Michael L. Weiner President, Biophan Technologies Bonnie Labosky Healthcare executive, formerly with Medtronic, Welch Allyn Theodore Greenberg Management consultant, former hedge fund manager Stan Yakatan Management consultant, former healthcare executive Management Team and Board of Directors: Biophan
Bradford C. Berk, M.D., Ph.D. Chairman of Medicine, University of Rochester Medical Center Herbert Hauptman, Ph.D. Nobel Prize winning chemist and mathematician, President of the Hauptman-Woodward Institute Ray Kurzweil Inventor, world-renowned scientist and futurist Kevin Parker, Ph.D. Dean and May Professor, University of Rochester Henry Spotnitz, M.D. Professor of Surgery, Columbia Presbyterian Medical Center Dave Glocker, Ph.D. President of Isoflux, Inc., thin film Coatings company Andreas Melzer, M.D. CEO of Biophan Europe, physician, and expert in MRI compatible vascular implants Frank Shellock, Ph.D. University of Southern California, leading expert in MRI safety of medical devices Jianhui Zhong, Ph.D. University of Rochester School of Medicine and Dentistry Scientific Advisory Board: Biophan
Milestones • Collect balance of $11 million from Medtronic • Acquire majority position in Myotech • Add management with cardiovascular industry experience • Present regulatory plan to the FDA in the U.S. • Start first clinical trials in Europe
Strong management team from J&J, Angiotech Strong Scientific Advisory Boards Myotech addresses large underserved markets, has proven core technology, and benefits from broad intellectual property coverage Market well in excess of $4 billion per annum Relationship with Boston Scientific/Guidant for stents, Heart valve and vena cava filter in development CRADA with FDA (May, 2006) on Safety Selling safety patents to Medtronic for $11 million Summary
Biophan Basics 15 Schoen Place Pittsford, NY 14534 585-267-4800 www.biophan.com info@biophan.com *Numbers as of 8/14/2007 Stock Symbol: OTC: BIPH Shares Outstanding: 97,398,918* Average Volume (90-day): 554,773*