What CairnSurgical does

CairnSurgical, Inc. is a Lebanon, New Hampshire–based medical technology company developing the Breast Cancer Locator (BCL) System, a patient-specific, 3D-printed surgical guidance platform designed to improve margin clearance during breast-conserving surgery (lumpectomy). The system comprises two components: the BCL, a customized photopolymer-resin surgical guide produced from supine MRI data with ports for bracketing wires that mark the tumor boundaries, and the Visualizer, an interactive 3D web tool that displays tumor shape, size, and distance from the skin and chest wall in the surgical (supine) position. The product directly addresses the ~20–25% re-excision rate associated with wire and seed localization by providing volumetric, patient-specific information that conventional localization does not capture.

The company generates revenue through B2B medical device sales of the BCL System to hospitals and cancer centers, with a quote-based, multi-year contract pricing model typical of capital-light surgical devices. Its go-to-market is enterprise field sales targeting academic medical centers and comprehensive cancer centers, including MD Anderson, Massachusetts General, and Dartmouth-Hitchcock in the U.S. and Spital Zollikerberg, Agaplesion Markus Krankenhaus, Brustzentrum Heidelberg, Santa Chiara, and Humanitas in Europe. As of 2026, the BCL System is commercially available in Europe (with ISO 13485 certification achieved in July 2025) and remains an investigational device in the U.S., where a De Novo 510(k) application was submitted in March 2026 following a 448-patient pivotal trial that met its primary endpoint.

CairnSurgical is a venture-backed private company with $4.5M in Series A2 financing led by Morningside Ventures in August 2024, on top of an earlier Series A led by Morningside Group in December 2019 through the DRIVEN Accelerator Hub operated by Celdara Medical. The co-founders — Richard Barth Jr., MD (CMO), Venkat Krishnaswamy, PhD (CTO), and Keith Paulsen, PhD — are Dartmouth/Thayer-affiliated researchers, and the company is led by CEO David Danielsen, a medical-device commercial veteran with prior experience at Hologic, Boston Scientific, and US Surgical.

Name

CairnSurgical

Legal name

Cairn Surgical, Inc.

Website

https://cairnsurgical.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

11–50 employees

Short description

CairnSurgical develops the Breast Cancer Locator (BCL) System, a patient-specific 3D-printed surgical guide and 3D visualization tool that uses supine MRI data to help breast surgeons achieve clear margins during lumpectomy, selling B2B to academic medical centers in Europe (commercial) and the U.S. (investigational, FDA De Novo pending).

Ownership category

akta.pro rank

Product category

Breast Surgery Medical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Interventional Radiology & Image-Guided Therapy Systems (HLAHABAG)

Keywords

• Surgical guidance devices
• 3D printed medical devices
• Breast cancer localization
• Patient-specific surgical tools
• Lumpectomy margin guidance

Headquarters

HQ city

Lebanon

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain, Infrastructure

Revenue model

1. Medical Device Sales: CairnSurgical generates revenue through the sale of its Breast Cancer Locator (BCL) System, which consists of patient-specific 3D-printed surgical guides and the Visualizer software. The device is commercially available in Europe and under clinical investigation in the U.S. Revenue is derived from sales to hospitals and surgical centers performing breast cancer procedures.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

CairnSurgical develops and sells the Breast Cancer Locator (BCL) System, a patient-specific, 3D-printed surgical guidance system designed to achieve clear margins during breast conserving surgery (lumpectomy). The system consists of a customized 3D-printed photopolymer resin form (the BCL) that fits each patient's unique breast shape and provides ports for guiding surgical wires to bracket the tumor, combined with the Visualizer, an interactive 3D web-based tool that displays tumor shape, size, location, and distance from skin and chest wall derived from supine MRI data. The device is commercially available in Europe and under FDA De Novo review in the U.S.

Product overview

CairnSurgical offers the Breast Cancer Locator (BCL) System, a unified product comprising two integrated components: the BCL (a patient-specific 3D-printed surgical guide) and the Visualizer (an interactive 3D visualization tool). The system is designed to improve the accuracy of breast conserving surgery (lumpectomy) by providing surgeons with detailed information about tumor size, shape, location, and margins derived from supine MRI data. The BCL System is commercially available in Europe and is undergoing U.S. pivotal trial evaluation for FDA clearance.

Differentiator

Problem solved

Functional benefit

Brands

• Breast Cancer Locator™ System (BCL™): A proprietary, patient-specific, 3D-printed surgical guidance system designed to achieve clear margins in breast cancer surgery
• Visualizer™

Products and services

• Breast Cancer Locator (BCL) System A proprietary, patient-specific, 3D-printed surgical guidance system designed to reduce positive margins during breast conserving surgery (lumpectomy). It provides surgeons with information about tumor size, shape, and margin boundaries to assist in precise tumor excision while preserving normal breast tissue, and is intended for hospitals, cancer centers, and breast surgeons performing breast conserving surgery.

Quantifiable outcome

• 94% margin-negative resection rate vs 20% historical positive margin rate with wire localization
• +4 more outcomes

Named customers7 records

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Two partnerships are on record, tiered core.

• Celdara Medical / DRIVEN Accelerator HubcoreStrategic or Co-development PartnerCairnSurgical was the first participant company in the DRIVEN Accelerator Hub, an initiative of Celdara Medical. The DRIVEN program provides acceleration support and resources for medical technology companies emerging from research institutions.
• European Clinical Trial SitescoreImplementation/ SI/ Consulting PartnerFive European clinical trial sites including Santa Chiara Hospital (Pisa), Spital Zollikerberg (Switzerland), Humanitas Research Hospital (Italy), Klinik Sankt Elisabeth (Heidelberg), and Agaplesion Markus Krankenhaus (Frankfurt). These sites conducted the European post-market surveillance study and are involved in early commercialization.

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Merit Medical Systems: Through its acquisition of Cianna Medical, Merit Medical offers the SAVI Scout wire-free breast tumor localization system — the most directly comparable commercial alternative to CairnSurgical's BCL. Both target the same lumpectomy workflow to reduce positive margins.
• Endomag: Endomag's Sentimag magnetic seed localization (Magseed) and Magtrace lymph node products are wire-free alternatives for breast conserving surgery. Like CairnSurgical, Endomag competes directly with wire and radioactive seed localization in lumpectomy.

Broad incumbents

• Hologic: Dominant player in breast health (mammography, biopsy, brachytherapy) with broad hospital relationships and the salesforce scale to commercialize competing breast surgery products. CairnSurgical's CEO previously held senior roles at Hologic, indicating familiarity with this competitive landscape.
• Becton, Dickinson and Company (BD): BD (including legacy C.R. Bard) supplies brachytherapy seeds, localization wires, and broader breast surgery consumables. A large incumbent with the resources to develop or acquire competing image-guided localization technologies.

Emerging players

• Lumicell: Lumicell is developing intraoperative imaging (LUM System) to detect residual cancer at the lumpectomy margin in real time. Adjacent problem space (reducing positive margins in BCS) with a different technological approach, making it a meaningful emerging competitor.
• iCAD: iCAD offers AI-powered breast cancer detection and risk assessment software used in mammography workflows. While not a surgical guidance device, it operates in the same breast cancer care pathway and could integrate or compete for hospital mindshare.
• Volpara Health: Volpara provides AI-based breast imaging analytics for mammography. Adjacent in the breast cancer care continuum; comparable as a small-cap, software-enabled breast health company pursuing enterprise hospital sales.
• Dilon Technologies: Dilon manufactures molecular breast imaging and gamma-guided localization systems (including the Dilon 6800 for wire-free lesion localization). A smaller competitor in the breast surgical localization space.

Others

• Faxitron (part of Hologic): Faxitron produces specimen radiography systems used intraoperatively to confirm margin status in lumpectomy. Comparable in addressing the positive-margin problem, but as equipment rather than a patient-specific guide.
• Carl Zeiss Meditec: Zeiss offers intraoperative microscopy and surgical visualization tools used in oncologic surgery. An enabling/adjacent player in image-guided surgery rather than a direct breast localization competitor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds2 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about CairnSurgical