InSight Surgical Technologies LLC — Department of Health and Human Services SBIR Phase I: 105

Description

PROJECT SUMMARY ABSTRACTInSight Surgical TechnologiesLLCis a newly formed start up founded by senior members of an NIH funded research collaboration involving faculty at Dartmouth and TorontoIn this Phase I SBIR applicationfeasibility of a disposable fiber optic probe connected to commercial ready instrument design will be demonstrated as progress towards realization of a near term medical producttermed qF ProbeTMfor quantitative intraoperative measurement of ALA induced PpIX concentrationCPpIXduring open cranial brain tumor resectionThe qF ProbeTM deviceonce commercialized will inform surgical resection decisionsespecially at or near the end of resectionor when tumor is adjacent to critical tissue functionduring these proceduresCommercialization will demonstrate not only the diagnostic value of quantitative CPpIXbut also the utility of a low cost hand held tool that rapidly returns this data when critical resection decisions need to be made in the operating roomORA research grade instrument has been used in more thanhighand low grade glioma patientsas well as other intracranial neoplasmsand atmajor US centersIt has demonstrated clinically profound resultsfor examplethat diagnostic levels PpIX fluorescence not visible or detectable with commercially available systemse gZeiss Bluecan be quantifiedAdditionallyqF ProbeTM can be designed to detectiother fluorophorese gfluoresceinABYetciiat depth below the immediate surgical surface or in the presence of a thin film of bloodandiiimultiple fluorophores in the same casein future versions of the commercial productInSightandapos s business plan includes qF ProbeTM as a first product to market that will establish the surgical value of quantitative CPpIXCritical to qF ProbeTM commercialization is realization of a single use disposable probe that can be sterilized and achieve performance comparable to the reusableand expensiveprobes used clinically to dateThuswe propose to investigate the feasibility of realizing a low cost disposable probe as critical to InSightandapos s business planWe will also produce a commercial instrument designhardware and softwareas the starting point for quality manufacturing of qF ProbeTM for regulatory approval in Phase II NarrativeFeasibility of developing a disposable fiber optic probe connected to commercial ready instrument design as a near term medical producttermed qF ProbeTMis proposed for quantitative intraoperative measurement of ALA induced PpIX concentrationCPpIXduring open cranial brain tumor resection in this Phase I application