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Biophan Technologies, Inc.
Investor Presentation
OTC: BIPH
Safe Harbor 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 •
Biophan History
• Founded in 2000 by Wilson Greatbatch and Michael
Weiner. Wilson Greatbatch is the inventor of the first
successful pacemaker, licensed to Medtronic in 1960,
and founder of Greatbatch, Inc. (NYSE: GB),
developers of batteries used in implantable devices.
• Over 200 patents for MRI safety of devices,
visualization of stents and heart valves, and other
innovations for medical devices
• Experienced team from J&J, Angiotech, and Bard
3 •
Two Main Lines of Business
• Commercializing the MYOTECH MYO-VAD™
product line
• Licensing MRI-safe and visualizable technologies
4 •
MYO-VAD™
&
Current Device Market
Heart Failure Treatment
Each year about one million people die from heart
failure (HF) in the U.S.
There are many medical approaches for treating HF –
all of which have very serious limitations!
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•
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Conventional emergency resuscitation
Traditional drug therapy
Ventricular Assist Devices (VADs)
Intra-aortic balloon pumps (IABP)
Transplant and Total Artificial Heart
To achieve a significant improvement in outcome
requires a paradigm shift in treatment methods.
6 •
The Paradigm Shift
Develop a safer and more effective device that
addresses both short-term support and recovery:
• Short-term support, e.g. minimize ischemic damage
• Longer-term support (when necessary) to enable recovery
of the heart and (ultimately) removal of the device/therapy
Offer a device therapy that is also:
• Cost effective (total procedure cost)
• Broadly available - not just at specialized cardiac centers
• Reimbursable under existing guidelines
• Permits effective delivery of therapeutic agents
7 •
The Product
Approach: Utilize the best blood pump ever
developed – the native human heart!
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
This technology has already saved human lives.
8 •
Biophan’s Cardiac Recovery System
Compared to Current VAD Technology
Existing VAD Technology
Biophan Technology
Perforates the heart and great vessels
Simple installation (~3 minutes) and removal
High risk of patient complications due to
clotting and stroke, bleeding, and infection
Non-blood contact design promises to provide
very low risk of patient complications
Average procedure cost: $205,800
Anticipated procedure cost: $60,000
Limited applications at specialized transplant
and cardiac centers
Wide array of applications likely to be available
at nearly every community and rural hospital
9 •
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 image above to view the video.
10 •
Clinical and Pre-clinical Results
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 experiments conducted to illustrate the wide array of
sizes and applications available.
11 •
Competitive Comparison
12 •
Market for Improved
Cardiac Recovery Systems
Bridge-to-Recovery
$1.2 billion
Provides short-term support while the heart heals from moderate injury; a very important and
growing market.
Acute Resuscitation
$1.1 billion
Important rapid-recovery during cardiac emergencies and maintaining cardiac output for short
periods of time. Significantly expanded market segment.
Bridge-to-Transplant
$200 million
Keeps patients alive until a new heart is available.
Destination Therapy
$10 billion
Permanent support. Huge potential for MYOTECH since other current design VAD problems
severely limit usage. Significantly expanded market segment.
Therapeutic Recovery
$14 billion
Longer-term support from serious disease or injury; the potential for many hearts to recover,
allowing device removal. A new market segment.
13 •
The Marketplace
Only 61 Active VAD Centers
120 Transplant Centers
960 Specialized Cardiac Centers
6800 Hospitals
14 •
MYOTECH
Potential
The technically
simple MYO-VAD™
promises to expand
the market to virtually
ALL hospitals.
$20B Market
Opportunity
Imaging for Stents and
Other Devices
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.
$6,000.0
$16,000
Data Source: Lehman Brothers, 12/30/05
Data Source: JPMorgan
Cardiac Resynchronization Therapy
$14,000
Drug Eluting Stents
Implantable Cardioverter Defibrillators
$5,000.0
Pacemakers
Sales, millions of US dollars
Sales, millions of US dollars
$12,000
$10,000
$8,000
$6,000
$4,000.0
$3,000.0
$2,000.0
$4,000
$1,000.0
$2,000
$0.0
$0
2002
16 •
2003
2004
2005
2006E
2009E
2003
2004
2005
2006E
2008E
Today‘s Stents Cannot be Imaged
for Detection of In-Stent Restenosis
Can‘t see inside stents to
detect blockage or
clotting; have to perform
an angiogram to estimate
blockage.
Resonant Stent
Biophan technology
allows doctors to look
inside stents and see
actual blockage or
clotting.
17 •
Blockage
Market Opportunities for
MRI Visualization Technologies
• Stents represent over a $5 billion market
– Biophan technology allows visualization under MRI to view
restenosis
– License to Boston Scientific provides 3-4% royalty
• Market for other visible devices over $1 billion, potentially
over $2 billion with acceptance of the PLATTO procedure
for atrial fibrillation
• Benefits
– MRI has the optimal tissue imaging-allows implanting and
diagnosing devices under MRI
– Allowing visualization of flow and position of device in tissue
• Biophan Europe has working prototypes of these devices,
several in animal trials
18 •
Detecting Blockage in Vena Cava Filter
While using MR Imaging
Without Biophan
With Biophan
Conventional MRI vena
cava filter; cannot see
inside
Active MRI vena cava filter
with Biophan technology
Thrombotic blockage is now visible.
Biophan also allows visualization of heart valves.
19 •
Solutions for
Pacemaker Safety
Issues of Pacemaker Safety
• Pacemakers, defibrillators and neurostimulators are all
contraindicated for MRI
• Over 3 million people with these devices are not able to
undergo MRI
• Over 600,000 devices ship annually in a $10 billion industry
• Biophan’s MRI safety solutions address the problems of:
– Lead heating that can impede device performance
– Induced voltages that can cause potentially fatal arrhythmias
• Biophan holds several patents on its solutions
21 •
Biophan Solutions for MRI Safety
• Medtronic has said MRI safe devices would be “the
new gold standard”
• Boston Scientific/Guidant has taken the first license to
Biophan’s technology
• Biophan has patented solutions and is working with
the FDA on establishing guidelines for safety
22 •
Lead Wire Winding
Demonstration of Effectiveness
45
Control
Existing manufacturers
pacing lead and IPG
Temperature (ºC)
40
35
Test Units
Control
Test unit #1
Test unit #2
30
OEM pacing leads
(similar to control) with
Biophan’s modified lead
construction
25
20
0
20
40
60
80
100
120
140
160
180
200
Time (seconds)
Heating is significantly reduced by changing lead construction.
23 •
Company
Biophan Overview
• Developing a cardiac recovery system to overcome the limitations
of today’s devices (bleeding, clotting, stroke, infection); it is also
MRI safe and image compatible
• Proprietary developments for pacemakers
• Proprietary solutions for making neurostimulators safe with MRI
• Proprietary solutions for making stents and heart valves visible
under MRI for diagnostics
• Develop and patent innovations that can move market share
between major biomedical device manufacturers
• Completed deal w/ Boston Scientific for $5 million equity investment
– both licensing and equity investment provisions
– MRI safety and image compatibility
25 •
Patent Portfolio
• Over 200 U.S. & foreign patents, licenses, or
applications
• 56 issued U.S. patents
• Over 100 U.S. pending applications
• License agreement with Boston Scientific
26 •
Management Team & Board of Directors
• Biophan’s Management Team holds decades of
combined experience in the biotechnology,
pharmaceutical, and medical fields.
• Biophan’s Board of Directors holds executivelevel expertise in the areas of finance, marketing,
patent law, and medical administration.
27 •
Biophan Scientific Advisory Board
Thirteen Scientific Advisors, including:
• Cardiovascular Researchers
• University Professors
– Biomedical
– Biomedical Engineering
– Biomedical Imaging
– Radiology
• Winner of the Nobel Prize for Chemistry
• Corporate President with over 25 U.S. Patents
• Technology Inventor
28 •
Myotech Advisory Board
Five Board Members, including:
• Chief, Division of Cardiothoracic Surgery and Director of
Cardiac Transplantation and Mechanical Support,
Associate Professor of Surgery at Ohio State Medical
Center
• Associate Professor of Cardiothoracic Surgery at Wright
State University of Medicine
• Professor of Cardiac Surgery at Duke University
• Professor of Medicine and Molecular Physiology and
Biophysics at Baylor School of Medicine
• Surgical Director of Cardiac Transplantation and LVAD
Programs at Duke University
29 •
Opportunity
Biophan Product Sales and Licensing Annuities
Add Up to a Strong Company
• Cardiac Support System
• Multi-billion dollar market
potential for advantaged
product sold through
strategic partner
• Stents, Vena Cava, Heart
Valve
• $100-$200 million annual
royalties
• Pacemaker, defibrillator,
neurostimulator safety
• $40 million annual royalties
31 •
Summary
• MYO-VAD™ advantage
• R&D agreement being developed with Siemens
• CRADA with FDA (May, 2006)
• Closed deal with Boston Scientific in 2005
• Heart valve and vena cava filter in development
• Vena Cava filter in animal trials
• Strong management team from J&J and Angiotech
• Strong Scientific Advisory Board
• In negotiations with pacemaker companies for technology
licenses for MRI safety
32 •
Biophan Basics
150 Lucius Gordon Drive
West Henrietta, NY 14586
585-214-2441
www.biophan.com
Stock Symbol: OTC: BIPH
Shares Trading: 82,805,243
Average Volume (90-day): 255,525
Figures as of 8/02/06.
33 •
Investor Relations:
Jim Blackman
PR Financial Marketing
713-256-0369
[email protected]