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

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Presentation on theme: "Nanotechnology for Medical Devices and Biomaterial Applications Michael Weiner, CEO, Biophan Technologies, Inc. World Nano-Economic Congress (WNEC) Ireland."— Presentation transcript:

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

2 (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.

3 (OTC BB: BIPH) Nanotechnology for Medical Devices and 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)

4 (OTC BB: BIPH) 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

5 (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.

6 (OTC BB: BIPH) 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

7 (OTC BB: BIPH) 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

8 (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

9 (OTC BB: BIPH) 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

10 (OTC BB: BIPH) 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

11 (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.

12 (OTC BB: BIPH) 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

13 (OTC BB: BIPH) 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

14 (OTC BB: BIPH) 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

15 (OTC BB: BIPH) SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated. 123 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

16 (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. Stent Implantation 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.

17 (OTC BB: BIPH) 1.5 Tesla MRI Artifacts of Current Stents Expanded Stents Original size Crimped Stents Cobalt 316L stainless steel With existing stent technology, no useful images can be obtained from within common stents using MRI.

18 (OTC BB: BIPH) 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 StentBlood Clot

19 (OTC BB: BIPH) 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”

20 (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)

21 (OTC BB: BIPH) Substrate Polymer Coating Nanomagnetic layer Controlled Magnetic Field Drug bound to NMP carrier Controlled Magnetic Field A Controlled Magnetic Field B Particle type A Drug A Particle type B Drug B Surface Elution on Demand

22 (OTC BB: BIPH) Reloading Drug Eluting Coatings Substrate Polymer Coating Concentration Gradient Controlled Magnetic Field Drug Molecules Drug bound to NMP carrier Nanomagnetic layer

23 (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 site 2 - Coating NMP with antibodies to target tumor

24 (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).

25 (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

26 (OTC BB: BIPH) 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

27 (OTC BB: BIPH) 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

28 (OTC BB: BIPH) Other Markets Battery: $500 million Contrast Agents: $800 million Drug Pumps: $1 billion Drug Delivery: $40 billion Cautions: 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

29 (OTC BB: BIPH) 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

30 (OTC BB: BIPH) Thank You! More good things will unfold in 2005! BIO med PHA rma N ano Technologies


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