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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.
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Nanotechnology for Medical Devicesand Biomaterial Applications Michael Weiner, CEO, Biophan Technologies, Inc. World Nano-Economic Congress (WNEC) Ireland April 20, 2005
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.
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)
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
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.
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
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
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
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
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
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.
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
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
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
MRI Device Imaging 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. 1 2 3 SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
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.
1.5 Tesla MRI Artifacts of Current Stents Cobalt Expanded Stents Original size With existing stent technology, no useful images can be obtained from within common stents using MRI. 316L stainless steel Crimped Stents
Imaging of In-Stent Blood Clots Using Biophan Resonator Technology Resonant Stent Blood Clot Cross Sectional Schematic of Stent with blood clot Video Biophan’s technology enables imaging of the blood clot within the stent 1 Tesla Philips NT, head coil, TR=300ms, TE=6ms, FA=40°, transversal
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”
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)
Particle type A Drug A Drug bound to NMP carrier Particle type B Drug B Surface Elution on Demand Controlled Magnetic Field A Controlled Magnetic Field Controlled Magnetic Field B Polymer Coating Nanomagnetic layer Substrate
Drug bound to NMP carrier Reloading Drug Eluting Coatings Concentration Gradient Drug Molecules Controlled Magnetic Field Polymer Coating Nanomagnetic layer Substrate
Apply magnetic field to concentrate particles Inject NMPs IV, NMP will circulate through the blood stream Modulate field to release drug from particles Guided Drug Delivery Other options for targeting: 1 - Direct injection into tumor site 2 - Coating NMP with antibodies to target tumor Solid tumor
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).
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
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
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
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
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
Thank You! More good things will unfold in 2005! BIOmedPHArmaNano Technologies