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CAIRNSURGICAL completes U.S. pivotal trial enrollment for Breast Cancer Locator System Published study reports 94% negative margins with the BCL System Series A2 financing closes at $4.5M, led by Morningside Ventures FDA submission announced · Limited commercial launch underway in Europe Dave Danielsen: “Now we’re letting them look at it ahead of time”
Profile · Medical Devices

Dave Danielsen

The CEO turning a patient’s MRI into a 3D-printed map for breast cancer surgery — and trying to make the second operation a thing of the past.

CEO, CairnSurgical Lebanon, NH Image-Guided Surgery
Dave Danielsen, CEO of CairnSurgical
David Danielsen · Chief Executive Officer
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The Story

Giving surgeons a map they never had

Dave Danielsen runs a company built around a single, stubborn question about breast cancer surgery: why is the surgeon expected to remove a tumor she cannot actually see? As CEO of CairnSurgical, a clinical-stage medical device company in Lebanon, New Hampshire, he has spent the last several years answering it in hardware and software. The company’s Breast Cancer Locator System takes a patient’s own imaging and turns it into a custom, 3D-printed form that fits that one breast and guides the surgeon to the exact edges of the cancer.

Danielsen likes to put the problem in plain terms. “Just imagine being told, ‘Go get this tumor out, but you’re not allowed to see what shape and what size it looks like in that patient,’” he has said. “Well, now we’re letting them look at it ahead of time.” The pitch is not about a flashier operating room. It is about a woman not having to come back for a second surgery because cancer cells were left behind at the margins.

CairnSurgical spun out of Dartmouth in 2015, founded by surgeon Dr. Richard J. Barth Jr. and engineers Keith D. Paulsen and Venkat Krishnaswamy. The science came from the lab. Danielsen’s job has been to turn it into a product that surgeons trust, regulators approve, and hospitals can actually afford to use. That is the less glamorous half of medtech, and it is the half he has spent his career doing.

By giving breast cancer surgeons detailed and critical information that they don’t have today, we intend to transform the surgical experience.
— Dave Danielsen, CEO, CairnSurgical
How It Works

From scan to surgical guide

The Breast Cancer Locator System has two parts that work together: a physical, single-use 3D-printed form and visualization software that lets the surgical team study the tumor’s size, shape, and location before the first incision. The result is a guide built for exactly one patient and used exactly once.

1

Image

The patient’s MRI is captured and used to build a precise 3D model of the tumor and surrounding tissue.

2

Print

A custom form is 3D-printed to match the unique contour of that patient’s breast.

3

Guide

In the operating room, the form and software guide the surgeon to the tumor’s boundaries and margins.

The Numbers

What the results show

94%
Negative margins in published study
$4.5M
Series A2 raised, Aug 2024
2015
Dartmouth spinoff founded
1
Guide per patient

A study published in Annals of Surgical Oncology reported that surgeons using the BCL System achieved negative margins — no cancer cells at the removed tumor’s edges — in 94% of patients. In lumpectomy terms, cleaner margins mean fewer patients sent back to the operating room. That clinical outcome is also the economic argument Danielsen makes to investors and hospitals alike.

Negative margins with BCL System (study)94%
Focus: reduce repeat surgeriesPrimary goal
We are delighted to have the continued support of Morningside Ventures, who believes in our vision of improving both outcomes for breast cancer patients and the healthcare economics of breast cancer surgery.
— Dave Danielsen, on the 2024 Series A2 round
The Path Here

West Point, Tuck, and a career in commercializing science

Danielsen’s route to medtech is not the standard one. He is a graduate of the United States Military Academy at West Point, and he later earned an MBA from Dartmouth’s Tuck School of Business. That Dartmouth connection has a nice symmetry: he now leads a company that spun out of the same institution.

Before CairnSurgical, he held leadership and commercial roles across health and diagnostics companies, including as CEO of CRA Health, where he worked on advanced breast health software for clinical decision-making, and CEO of CPR Therapeutics. Earlier in his career he spent time at diagnostics and device companies including Oxford Immunotec and Hologic. The common thread is commercialization — taking a technical product and building the trial data, the regulatory case, and the go-to-market around it.

Milestones

The road so far

1991
Earns his MBA from the Tuck School of Business at Dartmouth.
Earlier career
Commercial and leadership roles at Hologic and Oxford Immunotec; later CEO of CRA Health and CPR Therapeutics.
2015
CairnSurgical is founded as a Dartmouth spinoff by Barth, Paulsen, and Krishnaswamy.
2021
The Breast Cancer Locator System is named NH Tech Alliance Product of the Year.
Aug 2024
CairnSurgical closes a $4.5M Series A2 round led by Morningside Ventures.
2025
Danielsen presents the technology at LSI USA and LSI Europe; the 94% margin study is published.
2026
U.S. pivotal trial enrollment completed, FDA submission announced, and a limited European launch begins.
In His Own Words

Watch

Danielsen presents the Patient-Specific Breast Cancer Locator at the LSI Europe ’24 Emerging Medtech Summit.

Play on YouTube
Reading The Room

Notes and quirks

  • He frames the entire problem with a thought experiment: asking a surgeon to remove a tumor without being allowed to see its size or shape first.
  • The company name evokes a cairn, the stacked-stone trail marker — a quiet fit for a product built around guiding surgeons to a precise spot.
  • CairnSurgical is headquartered in Lebanon, New Hampshire, well outside the usual Boston and Bay Area medtech clusters.
  • He went to market in Europe first, while still working the U.S. FDA pathway — a sequencing choice that says a lot about how he balances speed and regulation.
Explore & Connect

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