# Probe for Quantitative Fluorescence. Phase 2

> **NIH NIH R44** · INSIGHT SURGICAL TECHNOLOGIES INC. · 2021 · $1,080,934

## Abstract

PROJECT SUMMARY
In this Phase II SBIR application, we will build on progress in Phase I to commercialize qF-ProbeTM for
quantitative intraoperative measurement of ALA-induced PpIX concentration (CPpIX) during open-cranial brain
tumor resection. Specifically, in Phase I, we developed a disposable probe design and prototypes that are
comparable in performance to our established reusable clinical-research probes, and created an instrument
design that meets clinical-user specifications, maintains accuracy/repeatability equivalent to our existing high-
performance research units and has additional flexibility for adaptation to other fluorophores. The qF-ProbeTM
concept arose as part of NIH-funding (R01 NS052274-09; PI: Roberts) in fluorescence-guided surgery
involving biomedical engineering/optics and neurosurgical research teams at Dartmouth and Toronto. InSight
Surgical Technologies LLC was then founded by the senior members of this collaboration who bring
substantial domain expertise. Commercialization is particularly timely, since (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 market leader in surgical robotics, Intuitive
Surgical.), (iii) interest from other MedTech companies (e.g., Medtronic, Zeiss) is high, and (iv) the extensive
clinical results demonstrate compelling advantages of quantitative CPpIX over qualitative and subjective visual
fluorescence imaging. Indeed, our research-grade instrument and reusable probes have been deployed in
>200 brain tumor patients at 2 major US centers and demonstrate that levels of PpIX fluorescence not visible
or detectable with commercially-available systems (e.g., Zeiss Blue 400) can be quantified. Doing so results in
significantly greater sensitivity and specificity for detection of residual tumor at end of white-light resection,
enabling more complete tumor removal, including in low-grade as well as high-grade tumors. Additionally, qF-
ProbeTM can be modified to detect (i) other fluorophores, (ii) tumor at depth below the resection bed and in the
presence of a thin film of blood, and (iii) multiple fluorophores in the same case. These capabilities will be
implemented in future products. InSight’s business plan positions qF-ProbeTM as the first product to market,
establishing the clinical value of fluorophore quantification during surgery. In Phase II, we will finalize the probe
and instrument designs under full QMS design-control and in compliance with industry regulations, produce up
to 5 fully functional qF-ProbeTM systems, validate the final design through clinical usability and survey data,
and apply to FDA for 510k regulatory clearance.

## Key facts

- **NIH application ID:** 10161873
- **Project number:** 5R44NS108845-03
- **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:** $1,080,934
- **Award type:** 5
- **Project period:** 2018-09-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10161873

## Citation

> US National Institutes of Health, RePORTER application 10161873, Probe for Quantitative Fluorescence. Phase 2 (5R44NS108845-03). Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/grant/nih/10161873. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*