InSight Surgical Technologies, LLC, is a newly formed start-up founded by senior members of an NIH-funded research collaboration involving faculty at Dartmouth and Toronto. In this Phase I SBIR application, feasibility of a disposable fiber-optic probe connected to commercial-ready instrument design will be demonstrated as progress towards realization of a near-term medical product, termed qF-ProbeTM, for quantitative intra- operative measurement of ALA-induced PpIX concentration (CPpIX) during open-cranial brain tumor resection. The qF-ProbeTM device, once commercialized will inform surgical resection decisions, especially at or near the end of resection, or when tumor is adjacent to critical tissue function, during these procedures. Commercialization will demonstrate not only the diagnostic value of quantitative CPpIX, but 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 room (OR). A research-grade instrument has been used in more than 200 high- and low-grade glioma patients, as well as other intracranial neoplasms, and at 2 major US centers. It has demonstrated clinically profound results ? for example, that diagnostic levels PpIX fluorescence not visible or detectable with commercially-available systems (e.g., Zeiss Blue 400) can be quantified. Additionally, qF-ProbeTM can be designed to detect (i) other fluorophores (e.g. fluorescein80,88,89, ABY-02990,91, etc.), (ii) at depth below the immediate surgical surface or in the presence of a thin film of blood92, and (iii) multiple fluorophores in the same case80,90 in future versions of the commercial product. InSight's business plan includes qF-ProbeTM as a first product to market that will establish the surgical value of quantitative CPpIX. Critical to qF-ProbeTM commercialization is realization of a single-use disposable probe that can be sterilized and achieve performance comparable to the reusable (and expensive) probes used clinically to date. Thus, we propose to investigate the feasibility of realizing a low-cost disposable probe as critical to InSight's business plan. We will also produce a commercial instrument design (hardware and software) as the starting point for quality manufacturing of qF-ProbeTM for regulatory approval in Phase II.
Feasibility of developing a disposable fiber-optic probe connected to commercial-ready instrument design as a near-term medical product, termed qF-ProbeTM, is proposed for quantitative intraoperative measurement of ALA-induced PpIX concentration (CPpIX) during open-cranial brain tumor resection in this Phase I application.