Wide-field quantitative fluorescence imaging system
Ended Project Grant Awarded Last action
- Award ID
- R44CA257355
- Recipient
-
Insight Surgical Technologies Inc. UEI RUHKJWW84LK4
- Awarding agency
-
National Cancer Institute
National Institutes of Health, Department of Health and Human Services
- Obligated
- $4,167,214
Award facts
- Assistance listing
- 93.394 Cancer Detection and Diagnosis Research
- Completion date
- Originally
- Funding
-
- $3,956,353.38 Federal
- $210,861.00 Non-federal
- Place of performance
- Lyme, NH 03768, USA
Award details come from USAspending.gov.
Description
- Abstract
- 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 >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.
Transactions
| Action | Federal | Non-federal | Date |
|---|---|---|---|
| Amendment | $0 | $0 | |
| Amendment | -$1 | $0 | |
| Amendment | -$1 | $0 | |
| Amendment | -$1 | $0 | |
| Amendment | -$329,983 | $0 | |
| Amendment | -$329,983 | $0 | |
| Amendment | -$329,983 | $0 | |
| Amendment | $329,983 | $0 | |
| Amendment | $329,983 | $0 | |
| Amendment | $0 | $0 | |
| Amendment | $0 | $0 | |
| Amendment | $919,748 | $0 | |
| Amendment | $919,748 | $0 | |
| Amendment | $1,012,560 | $0 | |
| Amendment | $1,012,560 | $0 | |
| Amendment | $210,861 | $0 | |
| Original award | $210,861 | $210,861 |
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Quick answers
Who received award R44CA257355?
R44CA257355 was awarded to Insight Surgical Technologies Inc. by National Cancer Institute (National Institutes of Health) on September 22, 2021.
How much is award R44CA257355 worth?
$4,167,214 has been obligated on R44CA257355: $3,956,353 in federal funding and $210,861 in non-federal funding.
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