# Advanced Surgical Pathology Device

> **NIH NIH R44** · SURGIVANCE, INC. · 2024 · $1,007,907

## Abstract

Abstract
Diagnosing diseases relies heavily on pathologically analyzing tissue samples from patients. For cancers alone,
over 30 million people undergo tissue biopsies annually in the US. While surgery currently represents the best
standard of care treatment to cure invasive cancers, its success depends on timely excision of the tumor before
it can spread. This is especially true for the removal of skin cancers, more common in the populace than all other
malignancies combined, with Mohs surgery deemed the best treatment of choice for its high skin cancer cure
rates. However, this procedure requires the repeated histopathological evaluation of patient tissue samples to
confirmation of cancerous or non-cancerous tissue. This time-consuming step requires freezing, slicing, and
preserving the tissue between microscope slides to take an image, adding 2-3 hours to surgical times. It
increases operative times and the risk of postoperative complications including skin infections, bleeding or
hematoma, wound dehiscence (disruption of recently repaired wounds), tissue necrosis, and pain. The process
is also expensive, requiring ~$70k of equipment to set up, and pricy reagents and highly trained staff to maintain.
There is an unmet need in the market for a cost-effective digital pathology solution to rapidly produce high-quality
images. SurgiVance is developing a confocal-based Surgical Pathology System (SPS) to non-invasively and
rapidly image intact specimens with high resolution. The SPS system uses a novel, patented line-scanning,
stage-scanning confocal microscope. The NIH Phase 1 funded prototype successfully images standard sized
specimens (5 mm x 10 mm) in only 17 seconds, at 1.2 µm lateral resolution and 8.6 µm optical section thickness.
In this Phase II project, SurgiVance has 3 specific aims: 1) Recreate the prototype SPS device in a partner
facility, which will perform design and engineering work to miniaturize the device, reduce its complexity, and
increase its durability for market use, 2) develop AI-based software to rapidly scan and map the surfaces of fresh
samples resected directly from patients, and 3) clinically validate the superior performance of SPS created 3D
digital images of fresh tissue samples in comparison to the standard-of-care histopathology in Mohs patients in
benchmarks established by the SurgiVance FDA Q-Sub Class II, 510(k) pathway to meet beachhead market
needs. This Phase II study will enable SurgiVance to shift the paradigm towards instant, digital 3D pathology,
that when integrated with SurgiVance’s AI-based diagnostics, could enable robust, reproducible, and rapid
automated diagnoses.

## Key facts

- **NIH application ID:** 10832690
- **Project number:** 5R44CA235915-03
- **Recipient organization:** SURGIVANCE, INC.
- **Principal Investigator:** Daniel Summer Gareau
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,007,907
- **Award type:** 5
- **Project period:** 2019-08-01 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10832690

## Citation

> US National Institutes of Health, RePORTER application 10832690, Advanced Surgical Pathology Device (5R44CA235915-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10832690. Licensed CC0.

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