# CairnSurgical, Inc.

> CairnSurgical is a clinical-stage medical device company in Lebanon, New Hampshire, building patient-specific surgical guidance for breast cancer lumpectomy. Its Breast Cancer Locator (BCL) System pairs a 3D-printed, bra-like form molded to each patient's anatomy with an interactive 3D Visualizer derived from supine MRI, giving surgeons a precise blueprint of a tumor's size, shape, depth and edges. The goal is to cut the 20 to 25 percent re-excision rate in breast-conserving surgery toward zero. Spun out of Dartmouth College and Dartmouth-Hitchcock Medical Center in 2015, the company reported 94 percent margin-negative resections in a European study and filed for FDA De Novo clearance in 2026.

- **Founded:** 2015
- **Headquarters:** Lebanon, New Hampshire, United States
- **Founders:** Richard Barth, MD (Co-founder, Professor of Surgery (clinical originator of the concept)), Venkat Krishnaswamy, PhD (Co-founder, engineering (imaging/3D)), Keith Paulsen, PhD (Co-founder, Professor of Engineering, Radiology and Surgery), David (Dave) Danielsen (CEO)
- **Team size:** 13 employees
- **Products:** Breast Cancer Locator (BCL) System, The Visualizer
- **Notable:** 94% margin-negative resections in a European multi-institutional study (33 per-protocol patients) published in Annals of Surgical Oncology (2025), with no additional shave margins at initial surgery., 100% negative margins in an earlier 14-patient pilot study (2022)., Named NH Tech Alliance 2021 Product of the Year for the Breast Cancer Locator System.

## Products & services

- **Breast Cancer Locator (BCL) System** — A patient-specific, 3D-printed surgical guide - a bra-like plastic form molded to the individual patient's breast anatomy - that lets a surgeon place markers bracketing the full tumor volume during breast conserving surgery, based on supine MRI imaging.
- **The Visualizer** — An interactive, web-based 3D model of the tumor derived from supine MRI. It displays tumor size, shape, location, depth, and a 1 cm margin boundary, and serves as both a pre-operative planning tool and an intraoperative reference.

## Achievements

- 94% margin-negative resections in a European multi-institutional study (33 per-protocol patients) published in Annals of Surgical Oncology (2025), with no additional shave margins at initial surgery.
- 100% negative margins in an earlier 14-patient pilot study (2022).
- Named NH Tech Alliance 2021 Product of the Year for the Breast Cancer Locator System.
- Completed enrollment in its US pivotal trial (announced early 2026).
- Filed an FDA De Novo 510(k) submission for the BCL System (2026).
- More than 90% of surgeons reported satisfaction using the BCL System in the European study.

## Latest updates

- **2026-03** — Announced FDA De Novo 510(k) submission for the Breast Cancer Locator System, a key step toward US market clearance.
- **2026-01** — Announced completion of enrollment in its US pivotal trial of the BCL System.
- **2025-11** — European study published in Annals of Surgical Oncology showing 94% margin-negative resections with the BCL System.
- **2024-08** — Closed $4.5M Series A2 financing led by Morningside Ventures to fund the US pivotal trial and a limited European commercial launch.

## Links

- Website: https://cairnsurgical.com
- LinkedIn: https://www.linkedin.com/company/cairnsurgical
- YouTube: https://www.youtube.com/watch?v=3pFTtnIoyPE

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Profile page: https://yespress.io/cairnsurgical-inc
Published by YesPress — https://yespress.io
Last updated: 2026-07-22