. "Appendix D: Case Studies." An Assessment of the Small Business Innovation Research Program at the National Institutes of Health. Washington, DC: The National Academies Press, 2009.
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An Assessment of the SBIR Program at the National Institutes of Health
ABM is a small company whose research has been funded almost entirely by a series of successful SBIR awards. Currently, ABM is poised to enter Phase III, and is seeking the funding needed to do so successfully.
The company was founded on SBIR awards in 1997, and expanded based on Phase II awards in 1999. It received additional SBIR awards in 2002, and some additional funding from DARPA, during the development of two complementary products: home sleep diagnosis products, and an initial sleep disorder screening product for use in office or other settings.
ABM has received six Phase II NIH awards, and seven Phase I NIH awards, and has been supported almost entirely by $6.3 million in SBIR awards and $700,000 from DARPA.
Primary Outcomes:
One product with FDA clearance and a second that has been submitted for clearance, both entering Phase III.
Six patents.
Publications.
Additional employment.
Partnerships: Possible pilot program with Waste Management, Inc.
Key SBIR issues:
Failure of Fast Track.
Better program manager accountability.
Commercialization/Phase III support.
Commercialization review.
Review quality and oversight.
Key recommendations:
Optional training program for reviewers.
1
Interview: In Carlsbad, CA, at Advanced Brain Monitoring, Inc., with Daniel Lebedowski, Chief Scientific Officer, and Chris Berkas, CEO. Both are co-founders.