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The Synthetic Bone Company™
Edward S. Ahn, Ph.D. The Synthetic Bone Company™ Utilizing Nanotechnology to Develop Medical Devices Angstrom Medica, Inc A New Boston Street Woburn, MA
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Angstrom Medica, Inc. - Proprietary and Confidential
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
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Nanotechnology and the Medical Device
510(k) or PMA? Physician Input Product Definition Regulatory Approval Manufacturing Sales Does nanotechnology solve a compelling clinical need? Can you make it? FINANCING Do the potential rewards out weigh risks? Angstrom Medica, Inc. - Proprietary and Confidential
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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
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Angstrom’s Products 100 nm 100 nm Bone Screws Spinal Fusion Devices
Angstromplasty Hip Fracture Prevention 100 nm 100 nm Angstrom Medica, Inc. - Proprietary and Confidential
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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
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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
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Angstrom’s Manufacturing Process
Precipitation Forging Machining 100 nm Angstrom Medica, Inc. - Proprietary and Confidential
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Angstrom Medica, Inc. - Proprietary and Confidential
Financing Grants Angel Investors Strategic Partners Institutional Investors Technical Risk Marketing Risk Execution Risk Angstrom Medica, Inc. - Proprietary and Confidential
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engineering small miracles™
Angstrom Medica, Inc A New Boston Street Woburn, MA
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