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FrostBite - A Unique Catheter for Endoscopic Cryoablation

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44CA183265-02A1
Agency Tracking Number: R44CA183265
Amount: $1,747,642.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NCI
Solicitation Number: PA16-302
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-08-15
Award End Date (Contract End Date): 2020-07-31
Small Business Information
Owego, NY 13827-1515
United States
DUNS: 150225337
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (607) 687-8701
Business Contact
Phone: (607) 237-9565
Research Institution

A growing number of studies have demonstrated that combinatorial approaches are providing a path for personalization of strategies to treat a wide array of disease statesWhile providing a promising path to revolutionize medicinethe evolution of personalizedminimally invasivecombinatorial therapies has been slowed as a result of technological limitationsAs suchthere is a pressing need for designing new devices to facilitate the development of paradigm changingminimally invasiveapproaches to treat diseased tissues in situ which enable trans disciplinary strategies to combat diseaseThis Phaseprojectwhich builds upon the success of the completed Phaseis designed to address this need through the development of a next generation flexible endoscopic compatible ablation catheter platformFrostBitefor the treatment of various gastrointestinal cancers including pancreatic and liver cancerThis multi functional platform will enable the application of multiple therapeutic and diagnostic approachespharmaceuticalablationamong othersin a single device format which when combined with novel vitamin Danalogs designed to increase the lethality of freezingwill provide for an enhanced treatment option for numerous cancersThe ability to deliver multi parametric treatment regimens of the FrostBite catheter is enhanced by the incorporation of a novel deployable thermosensor to monitor ablation zone formation in real timeThiswhen combined with advanced imaging approach compatibilityincluding endoscopic ultrasoundMRIand CTwill provide for unmatched control and visualization during a procedurePhaseactivities yielded a prototypemm needle tip catheter capable of delivering cryothermal insults to a target withinseconds creating a zone of destruction ofcm in less thanminsStudies into combinatorial drug thermal insults also demonstrated improved outcomes in tissue modelsThis Phaseis designed tominiaturize and test the next generation endoscopic compatible cryocatheterintegrate a novel in situ deployable multipoint thermal sensor to enable real time monitoring of the thermal profile of the target during ablationdevelop and evaluate a series of vitamin Danalogscommercial and noveland test the optimal combination device and analog protocol in an ex vivo engineered tumor model and in in vivo studiesThis project builds upon successful Pstudiesas well as othersand leverages the combined expertise of researchers from CPSIUniversity of OttawaBinghamton Universityand Johns Hopkins School of Medicine to develop a new surgical device and adjunctive drug combination approach to more effectively treat cancers of the liver and pancreasOnce completedthis project will provide for an effectiveminimally invasive treatment option for individuals suffering from these and other gastroenterological based cancers such as colorectalstomach and esophageal cancerSuccessful completion of this project will provide for a novel medical device enabling the development and application of advanced personalized treatment regimes fors of thousands of patients who suffer from numerous gastrointestinal tissue disease states which are untreatable or inadequately treated with today s state of the art devices yielding improved patient survival and quality of life The intent of this project is to develop a novel catheter for the treatment of gastrointestinal cancersincluding pancreatic and liver cancerCPSI Biotech successfully completed Phasestudies which resulted in the development of the GENFrostBite EUS cryocatheterUnder Phasethe company plans to complete the development of the GENmultifunctional catheter platform and establish a novel class of adjunctive vitamin Danalogs to serve as adjuncts for enhanced destruction of pancreatic and liver cancer

* Information listed above is at the time of submission. *

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