Real Time Visualization of Clot under X-Ray Using 'Clot-Paint', a Novel Iodinated
Department of Health and Human Services
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Small Business Information
BIOPSY SCIENCES, LLC
4900 CREEKSIDE DRIVE, STE C, CLEARWATER, FL, 33760
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (provided by applicant): Biopsy Sciences, LLC NIH SBIR Phase I Grant Application Real Time Visualization of Clot under X-Ray Using Clot-Paint , a Novel Iodinated Protein Receptor Bound Molecule Project Summary/Abstract There are over 750,000 new cases of stroke in the U.S. each year. Of those suffering a major stroke, one-third will recover, one-third will die and one-third will be permanently impaired. The costs to society to treat stroke patients exceed 58 billion dollars a year in the U.S. Current acute embolic stroke treatment options include intravenous TPA administered within 3 hours after symptoms appear, intra-arterial TPA within 6 hours after the stroke onset and mechanical thrombectomy using the FDA cleared MERCI L5 retrieval system up to 6 hours and possibly longer after symptoms appear. Other clot retrieval/ablation devices (AngioJet, Latis laser device, EPAR laser, Penumbra system, Neuoronet snare) are under investigation but are not commercially available. Clot removal is the ideal treatment because of the speed of reperfusion and the lower risk of bleeding. We believe that ability to see the clot in real time during the intervention will help to shorten the time to clot removal and expand the number of physicians willing to participate in treating embolic strokes. Lysis alone can take up to 3 hours to dissolve the clot where clot removal can be performed in less than 30 minutes. Our long term objective is to introduce a novel contrast agent, Clot-Paint that is injected onto the clot through a catheter placed into the occluded artery. Clot-Paint adheres tightly to the intra-arterial thrombus via protein receptor sites while at the same time containing sufficient iodine molecules rendering the clot opaque to the x-ray beam and visible under fluoroscopic imaging for an extended period of time. This new molecule is composed of a clot binding protein and iodinated molecules. This novel contrast agent will allow the neurointerventional radiologist or cardiologist to visualize the clot with real time fluoroscopic imaging, thus allowing for accurate device positioning into the clot and to confirm successful clot capture into the device before removal. In addition, any clot fragments that migrate downstream could be readily identified and removed. Discussions with doctors who currently perform stroke intervention about this new contrast agent have confirmed the high potential clinical utility of such a novel contrast agent. PUBLIC HEALTH RELEVANCE: Biopsy Sciences, LLC NIH SBIR Phase I Grant Application Real Time Visualization of Clot under X-Ray Using Clot-Paint , a Novel Iodinated Protein Receptor Bound Molecule Project Narrative There are over 750,000 new cases of stroke in the U.S. each year [1-3]. Of those suffering a major stroke, one-third will recover, one-third will die and one-third will be permanently impaired. Of the 750,000 strokes about half are caused by an embolic clot amenable to intervention [4, 5]. Other applications for this novel affinity contrast agent in vascular territory procedures include acute coronary thrombosis (84,000 patients/year/U.S.), peripheral arterial thrombosis (72,000 patients), DVT (75,000 patients) and PE (38,000) . All of these patients will benefit from this molecule. One other side benefit of this molecule will be elimination or significant reduction of continuous large volume contrast injection for easier visualization of the clot during these interventional procedures.
* information listed above is at the time of submission.