Transcript Angstrom Medica The Synthetic Bone Company™

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