Transcript MRI Safety and Image Compatibility The Solutions

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 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
3 •
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
4 •
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.
5 •
The MYO-VAD Versus
Existing VAD Technology
Existing 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 200 centers)
6 •
MYO-VAD Technology
• 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’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.
7 •
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
8 •
Clinical and Pre-clinical Results
from 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 experiments conducted to illustrate the wide array of
sizes and applications available.
9 •
Competitive Comparison
Features
10 •
Biophan’s Cardiac
Support System
Percutaneously
Installed VADs
Surgically
Installed VADs
Total Artificial
Heart
The Market Opportunity
Patient Opportunity by
Indication for Use
450
387,000
Patients (000s)
400
350
Bridge-to-Recovery
300
Acute Resuscitation
Bridge-to-Transplant
250
210,000
200
Therapeutic Recovery
Destination Therapy
150
100
50
0
Conventional VADs
MYO-VAD™
The unique features of the MYO-VAD provide the potential to
expand the addressable patient opportunity.
11 •
The Marketplace
Only 61 Active VAD Centers
120 Transplant Centers
960 Specialized Cardiac Centers
6800 Hospitals
12 •
MYOTECH
Potential
The technically
simple MYO-VAD
promises to expand
the market to virtually
ALL hospitals.
$20B Market
Opportunity
Market Segmentation for the MYO-VAD
The MYO-VAD will be introduced in sequential
models to address the following indications:
Product
Generation
Gen – 1
(External Drive)
Gen – 2
(With Various Therapies)
Gen – 3
(Fully Implantable)
13 •
Indication(s)
for Use
Market
Size
Bridge-to-Recovery
Acute Resuscitation
$3.4 Billion
Bridge-to-Transplant
Therapeutic Recovery
$14 Billion
Destination Therapy
$10 Billion
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
14 •
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.
15 •
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
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
Product
Stents
$5.57
Pacemakers
$3.39
ICDs
$3.16
CRT Devices
$3.68
Total
* Various royalty rates
Sources: JP Morgan and Lehman Brothers
17 •
2006 Market Size
US$ Billions
$15.8 billion
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 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
18 •
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)
19 •
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.
20 •
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
21 •
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
22 •
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
23 •
Management Team and
Board of Directors: Biophan
Management
Board of Directors
•
•
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
24 •
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
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
25 •
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
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
26 •
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
27 •
Biophan Basics
Stock Symbol: OTC: BIPH
Shares Outstanding: 83,431,699*
Average Volume (90-day): 441,050*
150 Lucius Gordon Drive
West Henrietta, NY 14586
585-214-2441
www.biophan.com
*Numbers as of 12/27/06
28 •
Investor Relations:
James Carbonera
Investor Relations Group
212-825-3210
www.investorrelationsgroup.com