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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.
2 •
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
3 •
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 patients where they present, not only at
the most advanced centers
4 •
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
5 •
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, noninvasively (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)
6 •
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
7 •
MRI Image Compatibility
Product
Stents
Biophan technology
allows doctors to noninvasively 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
8 •
Without Biophan
Technology
With Biophan
Technology
Resonant Stent
Blockage
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:
9 •
•
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.
10 •
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
11 •
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
12 •
Competitive Comparison
Features
13 •
Myotech CSS
Percutaneously
Installed VADs
Surgically
Installed VADs
Total Artificial
Heart
Clinical and Pre-clinical Results
Using 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).
14 •
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
15 •
Dr. James Lowe, Cardio-Thoracic Surgery
Duke University
• Video of Dr. James Lowe speaking about need
and market for Myotech
• Dr. Lowe is on the Myotech Scientific Advisory
Board
16 •
Scientific Advisory Board: MYOTECH
Mark P. Anstadt, MD, FACS. Chairman
Anthony Perez-Tamayo MD, PhD
Wright State University of Medicine – Assoc Professor
of Cardiothoracic Surgery. Co-founder and co-inventor.
Rush University Medical Center – Assistant Prof of
Cardiac and Thoracic Surgery, Director of Research.
William Holman, MD, FACC
Peer M. Portner, PhD, FACC, FAHA
U of Alabama at Birmingham – Professor and Chief of
CT Surgery, VA Hospital. VAD specialist.
Stanford Univ School of Medicine – Consulting Prof of
Cardiothoracic Surgery. World leader in VAD therapies
James Lowe, MD
Michael Sketch, MD
Duke University Medical Center – Professor of Cardiac
Duke University Medical Center – Professor of
Surgery and Pathology. Pioneered MYO-VAD™.
Cardiology (Interventional).
Douglas Mann, MD, FACC, FACP
Benjamin Sun, MD
Baylor College of Medicine – Professor, Chief of
Cardiology. Leader on molecular basis of heart failure.
Ohio State Univ Medical Center – Assoc Professor, Chief
of Cardiothoracic Surgery, and Director of Cardiac
Transplantation and Mechanical Support.
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.
17 •
Samuel Tisherman, MD
U of Pittsburgh Medical Center – Professor of Surgery,
Critical Care Specialist.
Management Team and
Board of Directors: Biophan
Management
Board of Directors
•
•
Michael L. Weiner
Chairman; former Chairman and CEO of St.
Jude Pacesetter, Inc.
President, Biophan Technologies; formerly
with Xerox Corporation
•
John Lanzafame
Chief Operating Officer; formerly with
Angiotech
•
•
•
Robert Wood
Stuart MacDonald
Michael L. Weiner
President, Biophan Technologies
Bonnie Labosky
Healthcare executive, formerly with
Medtronic, Welch Allyn
Chief Financial Officer
•
Dr. Guenter H. Jaensch
•
Theodore Greenberg
Management consultant, former hedge fund
manager
Vice-President, R&D; formerly with Johnson
& Johnson
•
Stan Yakatan
Management consultant, former healthcare
executive
18 •
Scientific Advisory Board: 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
19 •
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
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
20 •
Summary
• 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
21 •
Biophan Basics
Stock Symbol: OTC: BIPH
Shares Outstanding: 97,398,918*
Average Volume (90-day): 554,773*
15 Schoen Place
Pittsford, NY 14534
585-267-4800
www.biophan.com [email protected]
*Numbers as of 8/14/2007
22 •