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Biophan Technologies, Inc. OTC: BIPH
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Page 1: Biophan Technologies, Inc. OTC: BIPH

Biophan Technologies, Inc.

OTC: BIPH

Page 2: 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.

Page 3: Biophan Technologies, Inc. OTC: BIPH

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

Page 4: Biophan Technologies, Inc. OTC: BIPH

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

Page 5: Biophan Technologies, Inc. OTC: BIPH

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.

Page 6: Biophan Technologies, Inc. OTC: BIPH

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)

Page 7: Biophan Technologies, Inc. OTC: BIPH

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.

Page 8: Biophan Technologies, Inc. OTC: BIPH

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

Page 9: Biophan Technologies, Inc. OTC: BIPH

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.

Page 10: Biophan Technologies, Inc. OTC: BIPH

10 •

Competitive Comparison

Biophan’s Cardiac Support SystemFeatures

Percutaneously Installed VADs

Surgically Installed VADs

Total Artificial Heart

Page 11: Biophan Technologies, Inc. OTC: BIPH

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.

Page 12: Biophan Technologies, Inc. OTC: BIPH

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.

Page 13: Biophan Technologies, Inc. OTC: BIPH

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

Page 14: Biophan Technologies, Inc. OTC: BIPH

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

Page 15: Biophan Technologies, Inc. OTC: BIPH

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

Page 16: Biophan Technologies, Inc. OTC: BIPH

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

Page 17: Biophan Technologies, Inc. OTC: BIPH

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

Page 18: Biophan Technologies, Inc. OTC: BIPH

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

Page 19: Biophan Technologies, Inc. OTC: BIPH

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)

Page 20: Biophan Technologies, Inc. OTC: BIPH

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

Page 21: Biophan Technologies, Inc. OTC: BIPH

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

Page 22: Biophan Technologies, Inc. OTC: BIPH

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

Page 23: Biophan Technologies, Inc. OTC: BIPH

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

Page 24: Biophan Technologies, Inc. OTC: BIPH

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

Page 25: Biophan Technologies, Inc. OTC: BIPH

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

Page 26: Biophan Technologies, Inc. OTC: BIPH

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

Page 27: Biophan Technologies, Inc. OTC: BIPH

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

Page 28: Biophan Technologies, Inc. OTC: BIPH

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


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