# Advanced Surgical Pathology Device

> **NIH NIH R43** · SURGIVANCE, INC. · 2021 · $192,500

## Abstract

Each year, millions of Americans are diagnosed with skin cancer. The treatment with the highest cure rate and
best functional and cosmetic outcomes is Mohs Surgery. Mohs depends on standard histopathology, which is
slow, tedious and costly and is a 2-dimensional diagnosis, which may miss 3Dimensional information. This
process is usually analog, with humans evaluating the processed tissue to determine the diagnosis. There is a
need for an alternative that is faster and digital so that advanced analytics can improve diagnosis. Such a
product could tighten our diagnostic targeting of cancer and improve patient experience. Our product is an
advanced surgical pathology device and method to bring rapid diagnosis to the point of care. In our product,
an innovative optical imaging device is combined with innovative healthcare software that integrates into the
healthcare workflow with minimal re-structuring and minimal re-training of staff. Our long-term goal is to
replace standard histopathology with our device, that we believe will protect public health by increasing the
efficacy of surgical intervention against cancer. In the USA, there are 1,500 specialty Mohs surgeons, 20,000
general dermatologists and 1,000,000 total doctors of medicine who need highly accurate and easily
accessible pathology services. Our project investigates the potential of our device to improve patient
satisfaction and reduce morbidity and mortality by serving as a preferable alternative to standard frozen
histopathology in Mohs Surgery. Our Phase I specific aims are to show equivalent optical imaging performance
(quantified by the resolution, contrast and signal-to-noise ratio) of our product compared to standard pathologic
imaging and also show the potential for high throughput imaging and image processing, which will suggest
superiority over standard pathologic imaging. Our Phase II Aim will be to generate a deployment prototype
capable of supporting a multi-center clinical trial that will enable us to achieve FDA approval as a primary
diagnostic. Overall, biopsy processing is a multi-billion dollar market with several potential revenue streams
including disposable tissue compression chambers for tissue sample analysis, cryogenic storage, trade secret
staining solution that optimizes diagnostic image contrast, and remote or automated pathologic assessment of
specimens using generated digital images.

## Key facts

- **NIH application ID:** 10215333
- **Project number:** 3R43CA235915-01A1S1
- **Recipient organization:** SURGIVANCE, INC.
- **Principal Investigator:** Daniel Summer Gareau
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $192,500
- **Award type:** 3
- **Project period:** 2021-03-10 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10215333

## Citation

> US National Institutes of Health, RePORTER application 10215333, Advanced Surgical Pathology Device (3R43CA235915-01A1S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10215333. Licensed CC0.

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