文档介绍：“Paying for clinical trials with an SBIR grant”
Our experience obtaining millions of dollars through the NIH's Phase peting Renewal program
Adapted from a presentation to:
Washington Technology Center SBIR Breakfast
June 12, 2007
William Ross - Director of Software Engineering, Pathway MRI & Vice-President, VPDiagnostics
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Dr. William Kerwin - Associate Professor, Vascular Imaging Laboratory, University of Washington
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Background
Vascular Imaging Lab (VIL) researchers developed advanced imaging technology to visualize and quantify atherosclerosis (hardening of the arteries)
Dr. Kerwin of VIL teamed up with small business Pathway MRI and submitted Phase I & II SBIR proposals to NIH to mercialization of the technology
A software product, the Pathway Carotid Artery Platform (PCAP), was essfully delivered at the end of Phase II
PCAP was intended to help physicians identify patients most at risk for stroke
#3 cause of death
#1 cause of long-term disability
At least 88% caused by atherosclerotic plaque (“hardening of the arteries”)
“Vulnerable” plaque in the Carotid artery breaks off, travels to brain, blocks blood vessels, causes stroke
Stroke Facts
MRI imaging of Carotid plaque
Carotid plaque specimen
Carotid plaque MRI
Vulnerable plaque
(Display in “Notes” view for more information)
PCAP 3D display of Carotid plaque
Vulnerable plaque
SBIR Timeline
Pathway/VIL SBIR Collaboration Agreement since 2002
Pathway licensed VIL Intellectual Property (IP) in 2005
3 Patents Pending
Phase I: $99K Developed image analysis algorithms
Phase II: $940K mercial product, submitted “clinical aid” 510K to FDA
NIH/NHLBI funded Pathway MRI and VIL
(Display in “Notes” view for more information)
Pathway MRI:
mercial software product: PCAP
Had exclusive, worldwide license to UW Intellectual Property
Had no FDA approval to market
Was out of money
Result:
Product & IP license sold to investor to create VPDiagnostics, In