nanotechnology for medical devices and biomaterial applications

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Nanotechnology for Medical Devices and Biomaterial Applications Michael Weiner, CEO, Biophan Technologies, Inc. World Nano-Economic Congress (WNEC) Ireland April 20, 2005

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Nanotechnology for Medical Devices and Biomaterial Applications. Michael Weiner, CEO, Biophan Technologies, Inc. World Nano-Economic Congress (WNEC) Ireland April 20, 2005. Cautionary Statement. - PowerPoint PPT Presentation

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Page 1: Nanotechnology for Medical Devices and Biomaterial Applications

Nanotechnology for Medical Devicesand Biomaterial Applications

Michael Weiner, CEO, Biophan Technologies, Inc.World Nano-Economic Congress (WNEC) Ireland

April 20, 2005

Page 2: Nanotechnology for Medical Devices and Biomaterial Applications

(OTC BB: 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.

Page 3: Nanotechnology for Medical Devices and Biomaterial Applications

(OTC BB: BIPH)

Nanotechnology for Medical Devicesand Biomaterial Applications

• A Revolution Of Unknown Dimensions is underway in Medical Devices and Biomaterials

• It appears to be BIG!• It has been a long time in coming, and is based on many

sedimentary layers:– Instrumentation - Fabrication– Microscopy, SEM, TEM, AFM - Semiconductors– Thin Film - Cold War– Bioterrorism defense - Lucrative medical

markets– Government funding - Nanoeconomics (gold

in the hills)

Page 4: Nanotechnology for Medical Devices and Biomaterial Applications

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Point of View Worth 80 I.Q. Points- Alan Kay

• It is not just “nano”• It is thin film coating, MEMS, particulates,

extensions of bio and pharma• Combined with the rapid growth and successful

economic of implantable devices• And the tremendous economic success of drug

delivery coatings on stents• And there is a lot of money available for relative

high risk R&D• Medicine will change for the better• Fortunes will be made

Page 5: Nanotechnology for Medical Devices and Biomaterial Applications

(OTC BB: BIPH)

Some Observations and Trends

• The Drexler “Nanobot” a smart mechanical contraption with smarts and power, is only one small dimension of possibility space. It has been much in the public mind.

• However, smart particulates, active thin-film coatings, circulating synthetic antibodies, are working in labs today

• To fully understand the future dimensions of nanotech on medicine, one has to think on broader dimensions than what is “technically” considered “nano.”

• Because the innovations are moving all along the continuum of nano and micro and MEMS and coatings, and the innovations, to be valuable, do not need to be “nano.” Many are.

Page 6: Nanotechnology for Medical Devices and Biomaterial Applications

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Putting Things in Three Categories

• That which we know about and might be here already

• That which we think is coming

• The unexpected, breakthrough innovations

Page 7: Nanotechnology for Medical Devices and Biomaterial Applications

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Explosive Atmosphere of Innovation---

A Unique Time in History

• Only 45 years since the first successful implantable device (Wilson Greatbatch’s pacemaker, licensed to Medtronic)

• Only three years since the success of drug coated stents• Frost & Sullivan predicting a $40 BILLION MARKET• Unparalleled worldwide government investment in

nanotech• Public markets and venture capital supportive of

nanotech• Enormous open opportunity for intellectual property

generation• Instrumentation and new know-how open many new

potentials

Page 8: Nanotechnology for Medical Devices and Biomaterial Applications

(OTC BB: BIPH)

Some Examples

• New nanocoatings and material surfaces can – Improve biocompatibility and growth– Replace polymers for elution– Increase the elution life– Non-invasively control the elution rate– Add diagnostics without power– Expand minimally invasive surgery– Improve life and functionality of devices

• Thin film coatings can provide multiple functionality

• Lab on a Chip can be within a Thin Film Coating

Page 9: Nanotechnology for Medical Devices and Biomaterial Applications

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Some Nanotechnology Capabilities

• Combine radiation and hyperthermia or ablation• Attack cancer and other undesirables• Redirect cancer cells• Make non-toxic chemotherapy agents• Improve drug targeting• Provide non-invasive visualization• Provide non-invasive drug delivery and dosing• Preparing drugs as nanoparticles can improve

drug solubility, uptake and delivery, either orally, intravenously or topically

Page 10: Nanotechnology for Medical Devices and Biomaterial Applications

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Economics

• Many publicly funded nanotech companies• Alternatives to Venture Capital Financing• Biomedical and Pharmaceutical industries value IP• Enormous base of R&D and publications• Very fast acceleration of compounding technologies• Emergence of multi-purpose start-ups and small

companies (Biophan, Arrowhead, NanoProprietary, Nanosys, Ardesta, Advance Nano, et al)

• Significant market cap potentials for pre-revenue ventures (Biophan at $200 million)

• 20 year growth in sophistication of University tech transfer

Page 11: Nanotechnology for Medical Devices and Biomaterial Applications

(OTC BB: BIPH)

Biophan’s Mission• Enable over $12 billion worth of medical devices

shipping annually safe for use with MRI, and imageable. Many are not:– Guidewires, catheters, endoscopes, biopsy

needles– Pacemakers, defibrillators, neurostimulators,

drug pumps (safety issues, also imaging issues), pain control devices

– Stents, embolism clips, aneurysm clips, artificial hips, knees, most other orthopedics

• Bring other innovations for competitive advantage to biomedical device and pharmaceutical companies.

Page 12: Nanotechnology for Medical Devices and Biomaterial Applications

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Biophan’s Solutions

• MRI Safety: (many products contraindicated)– RF filter from Johns Hopkins (heating)

– Biophan multi-filar wire solution (heating)

– “Anti-Antenna” lead design (induced voltages)

• Image Compatibility

• Nanomagnetic particle thin film coatings (Nanoset, LLC and Alfred University)– Minimize image artifacts

– Makes catheters, guidewires, stents, and devices visible under MRI

Page 13: Nanotechnology for Medical Devices and Biomaterial Applications

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Core Business• Offering our customers competitive advantage

– Through proprietary solutions that can gain marketshare for them

– FDA approval is pursued by the customer– Marketing and distribution of the final device is theirs

• We sell high margin components and develop annuities for our shareholders

Page 14: Nanotechnology for Medical Devices and Biomaterial Applications

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Relationship With Boston Scientific

• Joint development agreement, originally entered into November, 2003

• Recently moved to second and third phase, and has expanded to multiple products

• One of the companies referred to in recent 10Q• Reached agreement on term sheet, working on

final contract phase

Page 15: Nanotechnology for Medical Devices and Biomaterial Applications

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SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.

1 2 3

Biophan’s thin-film

nanomagnetic particle

coating technology

provides a controllable,

“magnetic” signal

capable of creating an

image of the coated

device.

#3 is uncoated.

MRI Device Imaging

Page 16: Nanotechnology for Medical Devices and Biomaterial Applications

(OTC BB: BIPH)

Coronary Stents A stent is a support device for permanent

expansion of blood vessel to restore blood flow.

Implantation is done with X-ray guidance in a Cathlab, which exposes the patient to ionizing radiation and potentially kidney damaging X-ray contrast agents.

After implantation, there is currently no way to show a potential restenosis (re-narrowing) of the blood vessel using non-invasive diagnostic systems. Diagnosis requires another catheterization procedure.

StentImplantation

Biophan’s technology presents an alternative – using an MRI system for diagnosis of restenosis. MRI diagnosis provides advantages, since it is non-invasive and uses no harmful radiation and no iodine contrast agents.

Page 17: Nanotechnology for Medical Devices and Biomaterial Applications

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1.5 Tesla MRI Artifacts of Current Stents

Expanded

StentsOriginal size

Crimped

Stents

Cobalt

316L stainless steel

With existing stent

technology, no useful

images can be obtained from within

common stents using

MRI.

Page 18: Nanotechnology for Medical Devices and Biomaterial Applications

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Imaging of In-Stent Blood Clots Using Biophan Resonator Technology

1 Tesla Philips NT, head coil, TR=300ms, TE=6ms, FA=40°,

transversal

Cross Sectional Schematic of Stent with blood clot

Video

Biophan’s technology enables imaging of the blood clot within the stent

Resonant Stent Blood Clot

Page 19: Nanotechnology for Medical Devices and Biomaterial Applications

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Making Stents Imageable

• Seeing blockage of stents has required an invasive procedure

• Stents imageable under MRI would be competitively advantaged

• Biophan’s business is competitive advantage for our customers through technology innovation

• Nanoset has a thin-film, nanomagnetic coating solution

• AMRIS, now Biophan-Europe, has a “retrofit” solution• Both solutions are PATENTED! • Together we “cover the waterfront”

Page 20: Nanotechnology for Medical Devices and Biomaterial Applications

(OTC BB: BIPH)

Implications

• Impact the $5+ billion stent market

• Help manufacturers make pacemakers, defibrillators, neurostimulators safe, and imageable – competitive advantage to our licensees

• Make guidewires, catheters, endoscopes, biopsy needles safe and image compatible

• Opens the field of interventional medicine under MRI (currently only X-Ray/Fluoroscopy)

Page 21: Nanotechnology for Medical Devices and Biomaterial Applications

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Substrate

Polymer Coating

Nanomagnetic layer

Con

trol

led

Mag

netic

Fie

ldDrug bound to NMP carrier

Con

trol

led

Mag

netic

Fie

ld A

Con

trol

led

Mag

netic

Fie

ld B

Particle type ADrug AParticle type BDrug B

Surface Elution on Demand

Page 22: Nanotechnology for Medical Devices and Biomaterial Applications

(OTC BB: BIPH)

Reloading Drug Eluting Coatings

Substrate

Polymer Coating

Concentration G

radient

Controlled

Magnetic F

ield

Drug Molecules

Drug bound to NMP carrier

Nanomagnetic layer

Page 23: Nanotechnology for Medical Devices and Biomaterial Applications

(OTC BB: BIPH)

Guided Drug Delivery

Solid tumor

Apply magnetic field to concentrate particles

Modulate field to release drug from particles

Inject NMPs IV,NMP will circulate through the blood stream

Other options for targeting:1 - Direct injection into tumor site2 - Coating NMP with antibodies to target tumor

Page 24: Nanotechnology for Medical Devices and Biomaterial Applications

(OTC BB: BIPH)

NanoView™ MRI Contrast Agents

Nano-particulate technology has the potential to provide a new consumable

product capable of significantly enhancing MR detection sensitivity (i.e. lowest detectable concentration) and specificity (i.e. the ability to reliably

detect the desired substance).

Page 25: Nanotechnology for Medical Devices and Biomaterial Applications

(OTC BB: BIPH)

Biothermal Battery

• Goal: To provide a long-lived electrical power system for implanted medical devices– Powered by body heat differential.

• Acquired 51% interest in TE-Bio, which holds an issued U.S. patent for the battery

• Batteries are a $500 million market, sell for $100 to $225 each in the pacemaker, defibrillator and drug pump markets

• Sold to same customers who need MRI safety

Page 26: Nanotechnology for Medical Devices and Biomaterial Applications

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Agreement with NASA

• Announced agreement with NASA Ames Research Center for Nanotechnology to jointly develop the biothermal battery

– NASA wants technology for their long duration manned MARS mission for biosensing and miniature therapeutic devices

– Biophan gets commercial rights to jointly developed and NASA developed technology

– Nanotechnology and materials science advances makes the biothermal battery possible

Page 27: Nanotechnology for Medical Devices and Biomaterial Applications

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PROTECTED, PROTECTED!

• Technologies covered by– 114 U.S. Patents

• 36 ISSUED

• 78 pending or allowed

• Owned by Biophan or licensed exclusively to Biophan for the medical market

• Plus many International patents

Page 28: Nanotechnology for Medical Devices and Biomaterial Applications

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Other Markets

• Battery: $500 million

• Contrast Agents: $800 million

• Drug Pumps: $1 billion

• Drug Delivery: $40 billionCautions:

Penetration can take time

FDA approval and/or CE Mark could take time

Bright side is, once deal is underway, patents and annuity streams can last a long time

Page 29: Nanotechnology for Medical Devices and Biomaterial Applications

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Biophan (OTC: BIPH)We don’t make medical devices; We make them safe, and imageable, for MRI

And other competitive advantages for our customers

Four of our six technologies are based on nanotechnology

WWW.BIOPHAN.COM

Page 30: Nanotechnology for Medical Devices and Biomaterial Applications

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Thank You!

More good things will unfold in 2005!

BIOmedPHArmaNano

Technologies