Wide-Field Quantitative Fluorescence Imaging System

PROJECT SUMMARY In this Fast Track (Phase I + Phase II) SBIR application, we will evaluate feasibility (in Phase I) of an accurate, fast and low-cost instrument (qF-ImageTM) design for accurate wide-field imaging of the absolute concentration of the fluorophore PpIX (CPpIX) in the surgical field for guiding brain tumor resection, and demonstrate that design meets quantitative end-user specifications required for clinical acceptance. In Phase II, we will finalize the qF-ImageTM design identified in Phase I under a full quality management system (QMS) for design-control and in compliance with industry regulations, produce up to 5 fully functional qF-ImageTM units, validate the final design through clinical usability and survey data, and apply to FDA for 510k regulatory clearance. The qF- ImageTM concept arose as part of NIH-funding (R01NS052274-10; PI: Roberts) in fluorescence-guided surgery involving biomedical engineering/optics and neurosurgical research teams at Dartmouth and Toronto. InSight Surgical Technologies (IST) was founded recently by the senior members of this collaboration who bring substantial domain expertise. Commercialization is particularly timely: (i) ALA-PpIX fluorescence-guided surgery has been FDA-approved for high-grade glioma, (ii) substantial corporate moves have occurred in fluorescence-guided surgery indicating a significant global market (e.g., Stryker purchase of NOVADAC for ~$700M in 2017, and incorporation of fluorescence detection by a market leader in surgical robotics, Intuitive Surgical.), (iii) interest from other MedTech companies (e.g., Medtronic, Zeiss) is high, (iv) extensive clinical results demonstrate compelling advantages of quantitative CPpIX over qualitative and subjective visual fluorescence imaging, and (v) IST is the only venture pursuing commercialization of quantitative wide-field CPpIX images (the technology is protected by 9 issued/pending patents). Indeed, our research-grade instrument has been deployed in andgt;150 brain tumor patients: results demonstrate that levels of PpIX fluorescence not visible with commercial systems (e.g., Zeiss Blue 400) can be quantified with greater sensitivity and specificity for detection of residual disease at end of white-light resection, enabling more complete tumor removal, including in low-grade as well as high-grade cancers. Additionally, qF-ImageTM can be modified to detect (i) other fluorophores, (ii) tumor at depth below the resection bed, and (iii) multiple fluorophores in the same case – capabilities to be implemented in future products. InSight’s business plan positions qF-ImageTM as the first product on the market for wide-field imaging of CPpIX – the absolute concentration of PpIX in brain tumor.PROJECT NARRATIVE In this Fast Track (Phase I + Phase II) proposal, we will evaluate feasibility (in Phase I) of an accurate, fast and low-cost instrument, qF-ImageTM, for accurate, quantitative, wide-field imaging of the absolute concentration of the fluorophore, PpIX, in the surgical field for guiding brain tumor resection. In Phase II, we will finalize the qF- ImageTM design identified in Phase I under a full quality management system (QMS) for design-control and in compliance with industry regulations, produce up to 5 fully functional qF-ImageTM units, validate the final design through clinical usability and survey data, and apply to FDA for 510k regulatory clearance.