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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 MYO-VAD™ • A novel cardiac support system, with the potential to provide both short term support and recovery for patients with heart failure • Licensing of technologies for MRI Safety and Image Compatibility for various medical devices • Significant and disruptive technology that will provide a competitive advantage for stents, pacemakers, CRT devices, ICDs and neurostimulators
The MYO-VAD Opportunity The Problem Each year in the US, about one million people die from heart failure. • Existing Solutions • Each of the following approaches has significant limitations: • CPR / defibrillation • Traditional drug therapy • IABPs (intra-aortic balloon pumps) • VADs (ventricular assist devices) • Artificial hearts • Heart transplants
The MYO-VAD Cardiac Support System Approach: Energize the heart to pump blood without interacting with it. How it Works(Gen-1 Product) • Polymer cup that slips over the heart • Installed via a small chest incision • Attached to and driven by a small external pump • Sustains natural pulsatile flow • Avoids bleeding, clotting, infection This technology has already saved human lives.
Existing VAD Technology MYO-VAD Technology • Complex surgery, perforates the heart and great vessels • High risk of patient complications due to stroke, bleeding, and infection • Average procedure cost: $206,800 • Can only be installed at specialized transplant and cardiac centers (fewer than 200centers) • Easily installed (~3 minutes) and removed • No blood contact promises to reduce the risk of patient complications • Estimated procedure cost: $60,000 • Anticipate use at a majority of hospitals (6800 hospitals) The MYO-VAD Versus Existing VAD Technology
The MYO-VAD’s Potential Dr. James E. Lowe, Professor of Cardiac Surgery and Professor of Pathology at Duke University Medical Center Please click on the box to the right to view the video.
The MYO-VAD Opportunity The MYO-VAD has the following advantages: • No blood contact – minimizes the risk of stroke, etc. • Easily installed at a majority of hospitals, not just specialized cardiac centers • Cost-effective • Immediate resuscitation and support • Recovery and simple removal of the device • Delivery of various therapies
Clinical and Pre-clinical Resultsfrom Experimental Prototypes 1.Supported 45-year old for 2 days following massive myocardial infarction with no damage to the heart. 2. Supported 71-year old for 2 days following heart surgery with no damage to the heart or by-pass grafts. 3. Supported 56-year old for 2-1/2 days as a bridge to successful transplantation with no damage to native heart. 4. Supported 18-year old for 7-1/2 days until the heart healed from a viral myocarditis with no damage to the heart. 5. Supported 44-year old for 84 days with normal neurologic function with no damage to the heart. 6. Over 700 animal experimentsconducted to illustrate the wide array of sizes and applications available.
Biophan’s Cardiac Support System Percutaneously Installed VADs Surgically Installed VADs Total Artificial Heart Features Competitive Comparison
The Market Opportunity 387,000 210,000 The unique features of the MYO-VAD provide the potential to expand the addressable patient opportunity.
$20B Market Opportunity MYOTECH Potential 6800 Hospitals The Marketplace Only 61Active VAD Centers The technically simple MYO-VAD promises to expand the market to virtually ALL hospitals. 120Transplant Centers 960Specialized Cardiac Centers
Market Segmentation for the MYO-VAD The MYO-VAD will be introduced in sequential models to address the following indications:
Intellectual Property Estate:The MYO-VAD • Patent Protection • Comprehensive U.S. applications • Foreign filings in process • Additional applications being prepared • Technologies / Inventions Covered • Operational features • Diagnostic capabilities • Therapeutic capabilities
Scientific Advisory Board: MYOTECH Douglas Mann, MD, FACC, FACP Baylor School of Medicine – Professor of Medicine, Molecular Physiology, and Biophysics, and Chief of Cardiology. Director of the Winters Center for Heart Failure Research. Leading expert on heart failure. James Lowe, MD Duke University Medical Center– Professor of Cardiac Surgery and Professor of Pathology. Pioneered MYO-VAD™. Carmelo Milano, MD Duke University – Associate Professor of Surgery and Surgical Director of Cardiac Transplantation and LVAD Programs. Benjamin Sun, MD Ohio State University Medical Center – Associate Professor of Surgery, Chief of Cardiothoracic Surgery, and Director of Cardiac Transplantation and Mechanical Support. Anthony Perez-Tamayo MD, PhD Rush University Medical Center – Director of Research and Assistant Professor of Cardiac and Thoracic Surgery. Mark P. Anstadt, MD, FACS Wright State University of Medicine – Associate Professor of Cardiothoracic Surgery. Co-founder and co-inventor. Chairman of the Scientific Advisory Board.
Large and Growing Markets Need MRI Safe and MRI Visualization Technology Over $15.5 billion worth of products ship each year that have contraindications or limitations working with MRI.
The Market:MRI Safety and Image Compatibility • In excess of $15.8 billion in product value is shipped each year that has contraindications or poses other limitations for use in concert with MRI • Biophan’s revenue opportunity represents royalties (3 to 5%) on sales of products incorporating Biophan’s technology * Various royalty rates Sources: JP Morgan and Lehman Brothers
The Opportunity:MRI Safety and Image Compatibility The Problems A large number of medical devices have limitations when used in conjunction with MRI. • MRI Safety • Some devices are contraindicated and unsafefor use with MRI • These devices include pacemakers, ICDs, CRT devices, neurostimulators and others • MRI Image Compatibility • Many devices are safe but interfere with MRI imaging • These devices include stents, vena cava filters and others
The Opportunity:MRI Safety and Image Compatibility The Solutions • Technologies for MRI Safety • Discrete resonant circuits to block RF induced heating • Lead wire winding to reduce energy transfer / heating • Low pass filter for heat reduction • Wire looping to minimize induced voltages • Technologies for MRI Image Compatibility • Resonant circuit is tuned to the frequency of the MRI • Novel device designs to minimize image artifacts from: • Shielding (Faraday Cage effect), and • Materials (magnetic susceptibility artifacts)
Ambient = 25°C 30°C Skin Close-up of isotherms (Active fixation lead) MRI Safety Effectiveness of Biophan’s Solutions for MRI Safety of Pacemaker Leads Biophan Data Related to MRI Safety Testing Biophan is collaborating with the FDA under a CRADA to develop testing guidelines related to MRI safety.
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
Boston Scientific Scimed License • Executed in June 2005 (now includes Guidant) • Up-front payment – $750,000 • $5 million equity investment at a 10% premium • Total milestone payments through commercialization – $9.7 million • Exclusive for vascular implants (including stents) • Non-exclusive for: • Pacemakers, implantable defibrillators, neurostimulators • Catheters and guidewires • Royalty rates range from 3% to 5% of net sales
Intellectual Property Estate:MRI Safety and Image Compatibility • Patent Protection • 56 issued U.S. patents • In excess of 100 U.S. and foreign patents, licenses, or applications pending • Technologies / Inventions Covered • Novel device designs and geometries to improve MRI safety • Circuits and filters to improve safety and image compatibility • Nanomaterials and shielding • Photonics
Management Michael L. Weiner CEO, Biophan Technologies; entrepreneur; formerly with Xerox Corporation John Lanzafame Chief Operating Officer; formerly with Angiotech Darryl Canfield Chief Financial Officer; formerly with Genencor International Jeffrey L. Helfer Vice-President, Engineering; President, Cardiovascular Device Division; formerly with Johnson & Johnson 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 CEO, Biophan Technologies; entrepreneur Steven Katz Management consultant, former healthcare executive Theodore Greenberg Management consultant, former hedge fund manager 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 Harald Quick, Ph.D. Associate Professor of Radiology, University of Essen, Germany Mark E. Ladd, Ph.D. Professor and Director of Biomedical Imaging, University of Essen, Germany 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
Cardiac Support System Stents, Vena Cava, Heart Valve Pacemaker, defibrillator, neurostimulator safety Multi-billion dollar market potential for advantaged product sold through strategic partner $100-$200 million annual royalties $40 million annual royalties Biophan Product Sales and Licensing Annuities Add Up to a Strong Company
Summary • Strong management team from J&J, Angiotech • Strong Scientific Advisory Boards • MYO-VAD Cardiac Assist Device advantage • MRI Safe and Image Enhancing Technologies • Relationship with Boston Scientific • Heart valve and vena cava filter in development • CRADA with FDA (May, 2006) • In negotiations with pacemaker companies for technology licenses for MRI safety
Biophan Basics 150 Lucius Gordon Drive West Henrietta, NY 14586 585-214-2441 www.biophan.com *Numbers as of 12/27/06 Stock Symbol: OTC: BIPH Shares Outstanding: 83,431,699* Average Volume (90-day): 441,050* Investor Relations: James Carbonara Investor Relations Group 212-825-3210 www.investorrelationsgroup.com