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Edward S. Ahn, Ph.D. The Synthetic Bone Company ™. Utilizing Nanotechnology to Develop Medical Devices. Angstrom Medica, Inc. 150-A New Boston Street Woburn, MA 01801 781.933.6121 www.angstrommedica.com. Why Nanotechnology?. All inter actions occur at an inter face
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Edward S. Ahn, Ph.D. The Synthetic Bone Company™ Utilizing Nanotechnology to Develop Medical Devices Angstrom Medica, Inc. 150-A New Boston Street Woburn, MA 01801 781.933.6121www.angstrommedica.com
Why Nanotechnology? • All interactions occur at an interface • Maximize interactions by maximizing interface • Increase surface area to volume ratio • Unique size dependent properties Angstrom Medica, Inc. - Proprietary and Confidential
Nanotechnology and the Medical Device 510(k) or PMA? Physician Input Product Definition Regulatory Approval Manufacturing Sales Can you make it? Does nanotechnology solve a compelling clinical need? FINANCING Do the potential rewards out weigh risks? Angstrom Medica, Inc. - Proprietary and Confidential
Defining The Product • Compelling Clinical Need • What kind of product? • Incremental product improvement • Revolutionary procedure • Issues • Technology looking for a home • How do clinicians contextualize nanotechnology? • Are there more conventional alternatives? Angstrom Medica, Inc. - Proprietary and Confidential
100 nm 100 nm Angstrom’s Products Bone Screws Spinal Fusion Devices Angstromplasty Hip Fracture Prevention Angstrom Medica, Inc. - Proprietary and Confidential
FDA Approval • Same but different strategy • First nanomedical device approved by FDA • Nanocrystalline CaP bone void filler • Incremental product improvement • Should be 510(k) • Bone screws and spinal fusion devices • Revolutionary Procedure • May require clinical trials • Angstromplasty Angstrom Medica, Inc. - Proprietary and Confidential
Manufacturing • Nanotechnology = Expensive? • Infrastructure • Specialized talent • Multi-step processing • Limited outsourcing • Reproducibility and Reliability • Nanotechnology is stochastic Angstrom Medica, Inc. - Proprietary and Confidential
100 nm Angstrom’s Manufacturing Process Precipitation Forging Machining Angstrom Medica, Inc. - Proprietary and Confidential
Grants Angel Investors Strategic Partners Institutional Investors Technical Risk Marketing Risk Execution Risk Financing Angstrom Medica, Inc. - Proprietary and Confidential
engineering small miracles™ Angstrom Medica, Inc. 150-A New Boston Street Woburn, MA 01801 781.933.6121 www.angstrommedica.com