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2 •
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.
3 •
Description of Business
A medical device company with two lines of business:
• Commercialization of the MYOTECH CSS
– A novel circulatory support system, with unique advantages in providing circulatory support and recovery in patients with acute 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
4 •
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)
5 •
The Myotech Circulatory Support System
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.
Approach: Pump the heart without contacting circulating blood.
6 •
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
7 •
The Expanded Marketplace
• Currently, in the US, there are
– 67 active destination therapy centers
– 120 transplant centers
– 960 specialized cardiac centers
– But 6,800 hospitals
• The Myotech CSS:
– is technically simple to install,
– enables use in a much larger segment of the 6,800 hospitals in the US
– reaches the patients where they present, not only at the most advanced centers
8 •
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
– Addressable WW market of over $4.5 billion
• Future Potential
– Evolutionary product generations will address therapeutic recovery and destination therapy market segments, additional multi-billion dollar opportunities
9 •
Competitive Comparison
Myotech CSSFeatures
Percutaneously Installed VADs
Surgically Installed VADs
Total Artificial Heart
10 •
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 experiments conducted to evolve and evaluate the technology (over wide spectrum of applications).
11 •
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
12 •
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.
Scientific Advisory Board: MYOTECH
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.
13 •
The Market:MRI Safety and Image Compatibility
• In excess of $15.8 billion in product value is shipped each year that has contraindications or other limitations for use with MRI
• Biophan’s revenue opportunity represents royalties (3 to 5%) on sales of products incorporating Biophan’s technology
Product2006 Market Size
US$ Billions
Stents $5.57
Pacemakers $3.39
ICDs $3.16
CRT Devices $3.68
Total $15.8 billion
Sources: JP Morgan and Lehman Brothers
14 •
The Opportunity:MRI Safety and Image Compatibility
The ProblemA large number of medical devices have limitationswhen used in conjunction with MRI.• MRI Safety
– Some devices are contraindicated and unsafe for 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
15 •
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:
o Shielding (Faraday Cage effect), and
o Materials (magnetic susceptibility artifacts)
16 •
MRI Safety
Biophan is collaborating with the FDA under a CRADA to develop testing guidelines related to MRI safety.
Close-up of isotherms(Active fixation lead)
30°CSkin
Ambient = 25°C
20
25
30
35
40
45
0 20 40 60 80 100 120 140 160 180 200
Time (seconds)
Te
mp
era
ture
(ºC
)
Control
Test unit #1
Test unit #2
Effectiveness of Biophan’s Solutions for MRI Safety of Pacemaker Leads
Biophan Data Related to MRI Safety Testing
17 •
MRI Image Compatibility
Stents
Biophan technology allows doctors to non-invasively image stents to visualize thrombus or in-stent restenosis
Resonant Stent Blockage
Vena Cava Filters
Biophan technology allows doctors to non-invasively image vena cava filters to visualize thrombus
With Biophan Technology
Without Biophan TechnologyProduct
18 •
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
19 •
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
20 •
Management Team and Board of Directors: Biophan
Management• Michael L. Weiner
President, Biophan Technologies; formerly with Xerox Corporation
• John LanzafameChief Operating Officer; formerly with
Angiotech
• Bob WoodChief Financial Officer
• Stuart MacDonaldVice-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. WeinerPresident, Biophan Technologies
• Bonnie LaboskyHealthcare executive, formerly with
Medtronic, Welch Allyn
• Theodore GreenbergManagement consultant, former hedge fund
manager
• Stan YakatanManagement consultant, former healthcare
executive
21 •
Scientific Advisory Board: Biophan
• Bradford C. Berk, M.D., Ph.D.Chairman of Medicine, University ofRochester Medical Center
• Herbert Hauptman, Ph.D.Nobel Prize winning chemist andmathematician, President of the Hauptman-Woodward Institute
• Ray KurzweilInventor, world-renowned scientist and futurist
• Kevin Parker, Ph.D.Dean and May Professor, University of Rochester
• Henry Spotnitz, M.D.Professor of Surgery, Columbia PresbyterianMedical Center
• Dave Glocker, Ph.D.President of Isoflux, Inc., thin filmCoatings company
• Andreas Melzer, M.D.CEO of Biophan Europe, physician, andexpert in MRI compatible vascular implants
• Frank Shellock, Ph.D.University of Southern California, leadingexpert in MRI safety of medical devices
• Jianhui Zhong, Ph.D.University of Rochester School of Medicine and Dentistry
22 •
Summary
• Strong management team from J&J, Angiotech
• Strong Scientific Advisory Boards
• Myotech addresses large underserved markets, proven core technology, broad intellectual property coverage
• MRI Safe and Image Enhancing Technologies
• Relationship with Boston Scientific/Guidant for stents, pacemaker/defibrillator and neurostimulators
• Heart valve and vena cava filter in development
• CRADA with FDA (May, 2006)
• In negotiations with pacemaker and neurostimulation companies for addt’l licenses for MRI safety technology