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Biophan Technologies, Inc.
OTC: BIPH
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 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
4 •
The MYO-VAD Opportunity
The Problem
Each year in the US, about one million people die from heart failure.
Existing SolutionsEach 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
5 •
The MYO-VAD Cardiac Support System
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.
Approach: Energize the heart to pump blood without interacting with it.
6 •
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)
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)
7 •
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.
8 •
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
9 •
Clinical and Pre-clinical Resultsfrom 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.
10 •
Competitive Comparison
Biophan’s Cardiac Support SystemFeatures
Percutaneously Installed VADs
Surgically Installed VADs
Total Artificial Heart
11 •
The Market Opportunity
Patient Opportunity by Indication for Use
0
50
100
150
200
250
300
350
400
450
Conventional VADs MYO-VAD™
Pat
ien
ts (
000s
) Bridge-to-Recovery
Acute Resuscitation
Bridge-to-Transplant
Therapeutic Recovery
Destination Therapy
210,000
387,000
The unique features of the MYO-VAD provide the potential to expand the addressable patient opportunity.
12 •
The Marketplace
120 Transplant Centers
960 Specialized Cardiac Centers
Only 61 Active VAD Centers
6800 Hospitals$20B Market Opportunity
MYOTECH Potential
The technically simple MYO-VAD
promises to expand the market to virtually
ALL hospitals.
13 •
Market Segmentation for the MYO-VAD
The MYO-VAD will be introduced in sequential models to address the following indications:
ProductGeneration
Indication(s) for Use
Market Size
Gen – 1
(External Drive)
Bridge-to-Recovery
Acute Resuscitation
Bridge-to-Transplant
$3.4 Billion
Gen – 2
(With Various Therapies)Therapeutic Recovery $14 Billion
Gen – 3
(Fully Implantable)Destination Therapy $10 Billion
14 •
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
15 •
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.
Scientific Advisory Board: MYOTECH
16 •
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.
$0.0
$1,000.0
$2,000.0
$3,000.0
$4,000.0
$5,000.0
$6,000.0
2003 2004 2005 2006E 2008E
Sal
es, m
illio
ns
of
US
do
llars
Drug Eluting Stents
Data Source: Lehman Brothers, 12/30/05
$0
$2,000
$4,000
$6,000
$8,000
$10,000
$12,000
$14,000
$16,000
2002 2003 2004 2005 2006E 2009E
Sal
es, m
illio
ns
of
US
do
llars
Cardiac Resynchronization Therapy
Implantable Cardioverter Defibrillators
Pacemakers
Data Source: JPMorgan
17 •
The Market:MRI Safety and Image Compatibility
• In excess of $15.8 billion in product value is shipped each year that has contraindications or poses other limitations for use in concert with MRI
• Biophan’s revenue opportunity represents royalties (3 to 5%) on sales of products incorporating Biophan’s technology
Product2006 Market Size
US$ Billions
Stents $5.57
Pacemakers $3.39
ICDs $3.16
CRT Devices $3.68
Total $15.8 billion
Sources: JP Morgan and Lehman Brothers
* Various royalty rates
18 •
The Opportunity:MRI Safety and Image Compatibility
The ProblemsA 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
19 •
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)
20 •
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
21 •
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
22 •
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
23 •
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
24 •
Management Team and Board of Directors: Biophan
Management• Michael L. Weiner
CEO, Biophan Technologies; entrepreneur; formerly with Xerox Corporation
• John LanzafameChief Operating Officer; formerly with Angiotech
• Darryl CanfieldChief Financial Officer; formerly with Genencor
International
• Jeffrey L. HelferVice-President, Engineering; President,
Cardiovascular Device Division; formerly with Johnson & Johnson
• 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. WeinerCEO, Biophan Technologies; entrepreneur
• Steven KatzManagement consultant, former healthcare
executive
• Theodore GreenbergManagement consultant, former hedge fund
manager
25 •
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
• Harald Quick, Ph.D.Associate Professor of Radiology, University of Essen, Germany
• Mark E. Ladd, Ph.D.Professor and Director of BiomedicalImaging, University of Essen, Germany
• 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
26 •
Biophan Product Sales and Licensing Annuities Add Up to a Strong Company
• Cardiac Support System
• Stents, Vena Cava, Heart Valve
• Pacemaker, defibrillator, neurostimulator safety
• Multi-billion dollar market potential for advantaged product sold through strategic partner
• $100-$200 million annual royalties
• $40 million annual royalties
27 •
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
28 •
Biophan Basics
150 Lucius Gordon Drive
West Henrietta, NY 14586
585-214-2441
www.biophan.com
*Numbers as of 12/27/06
Stock Symbol: OTC: BIPH
Shares Outstanding: 83,431,699*
Average Volume (90-day): 441,050*
Investor Relations:James Carbonera
Investor Relations Group212-825-3210
www.investorrelationsgroup.com