Transcript BTI Investor Presentation Pre Aug 07

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 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
3 •
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:
4 •
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CPR / defibrillation
•
Traditional medical therapy
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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.
5 •
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
6 •
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
7 •
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
8 •
Competitive Comparison
Features
9 •
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).
10 •
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
11 •
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.
12 •
Samuel Tisherman, MD
U of Pittsburgh Medical Center – Professor of Surgery,
Critical Care Specialist.
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
Product
Stents
$5.57
Pacemakers
$3.39
ICDs
$3.16
CRT Devices
$3.68
Total
Sources: JP Morgan and Lehman Brothers
13 •
2006 Market Size
US$ Billions
$15.8 billion
The Opportunity:
MRI Safety and Image Compatibility
The Problem
A large number of medical devices have limitations
when 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
14 •
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)
15 •
MRI Safety
Effectiveness of Biophan’s Solutions
for MRI Safety of Pacemaker Leads
Biophan Data Related to
MRI Safety Testing
45
Ambient = 25°C
Temperature (ºC)
40
35
Control
Test unit #1
Test unit #2
30
30°C
Skin
25
20
0
20
40
60
80
100
120
Time (seconds)
140
160
180
200
Close-up of isotherms
(Active fixation lead)
Biophan is collaborating with the FDA under a CRADA to develop
testing guidelines related to MRI safety.
16 •
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
17 •
Without Biophan
Technology
With Biophan
Technology
Resonant Stent
Blockage
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
18 •
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
19 •
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
•
•
•
Bob 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
20 •
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
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Henry Spotnitz, M.D.
Professor of Surgery, Columbia Presbyterian
Medical Center
•
Dave Glocker, Ph.D.
President of Isoflux, Inc., thin film
Coatings company
21 •
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
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
22 •
Biophan Basics
Stock Symbol: OTC: BIPH
Shares Outstanding: 95,877,536*
Average Volume (90-day): 317,360*
15 Schoen Place
Pittsford, NY 14534
585-267-4800
www.biophan.com
*Numbers as of 7/18/2007
23 •