# Wide-Field Quantitative Fluorescence Imaging System

> **NIH NIH R44** · INSIGHT SURGICAL TECHNOLOGIES INC. · 2021 · $210,861

## Abstract

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 >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.

## Key facts

- **NIH application ID:** 10255745
- **Project number:** 1R44CA257355-01A1
- **Recipient organization:** INSIGHT SURGICAL TECHNOLOGIES INC.
- **Principal Investigator:** DAVID W ROBERTS
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $210,861
- **Award type:** 1
- **Project period:** 2021-09-22 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10255745

## Citation

> US National Institutes of Health, RePORTER application 10255745, Wide-Field Quantitative Fluorescence Imaging System (1R44CA257355-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10255745. Licensed CC0.

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