Cairn Surgical, Inc., an innovative medical technology firm striving to make breast cancer surgery more precise, announced today that patient enrollment has been completed in the U.S. pivotal trial of its Breast Cancer Locator (BCL^TM) System. The BCL System is designed to improve the accuracy of breast conserving surgery (lumpectomy) by providing detailed guidance regarding tumor shape, size, and location that can help surgeons achieve clear margins.

“We are pleased with both the BCL performance and the study results we have seen with this intriguing new technology in this large randomized controlled study,” said Jennifer Gass, MD, Principal Investigator of the BCL study, Chief of Surgery, Women & Infants Hospital, and Professor of Surgery, Obstetrics and Gynecology, The Warren Alpert Medical School of Brown University. “The BCL System enabled us to map disease extent in unprecedented detail to guide more successful excision more often.”

The Breast Cancer Locator (BCL) Study is a prospective, multicenter, 1:1 randomized, controlled pivotal trial of breast cancer excision surgery in women with non-palpable invasive breast cancer or ductal carcinoma in situ (DCIS). Patients were randomized to either the BCL or standard wire localization to guide surgery. The primary endpoint is positive margin rate, with other endpoints being specimen volumes, rate of additional shave biopsies, re-excision rate, cancer localization rate, operative time and cost of care.

A European study published in November 2025 in the Annals of Surgical Oncology¹ showed that the BCL System enabled breast surgeons to successfully remove breast tumors with negative margins in 94% of patients, with no additional shave margins needed at the time of initial surgery and with safety outcomes comparable to typical breast conserving surgery. Surgeons were able to remove less tissue volume than that demonstrated in other studies, resulting in high patient satisfaction with the cosmetic appearance of their breasts following surgery. More than 90% of surgeons were satisfied with their experience using the BCL System.

“Our vision is to provide a more accurate template of cancer extent, and thus spare women with breast cancer from repeat surgeries to remove cancer that was missed the first time. The detailed information on tumor size, shape and location offered by our BCL System is designed to improve a surgeon’s precision in removing the tumor, leaving a negative margin with no detectable cancer left behind,” said Richard Barth, Jr., MD, Chief of General Surgery, Dartmouth-Hitchcock Medical Center, Professor of Surgery, Geisel School of Medicine at Dartmouth, and Cairn Surgical Co-Founder. “Completing our U.S. clinical trial is a major milestone along our path to providing physicians and patients with a better way to treat breast cancer.”

The BCL System is designed to reduce positive margin rates and to improve the workflow of breast conserving surgery. A supine MRI with the breast positioned in its surgical position for greatest accuracy is first performed, with a customized 3D-printed form – the BCL – designed and produced from the image to fit the unique shape of that patient’s breast. During surgery, the BCL and the Visualizer – an interactive, real-time, 3D image of the tumor in the breast – are used by the surgeon to provide valuable references during tumor excision.

The company is preparing to submit the results of the study and other information to the FDA in the coming weeks.

About Cairn Surgical

Cairn Surgical, Inc. is developing patient-specific guides using patient imaging data and state-of-the-art 3D printing technologies that are commercially available in Europe and being studied in a U.S. pivotal trial. Cairn Surgical’s Breast Cancer Locator (BCL) System is designed to enable precise tumor localization and excision.

The Breast Cancer Locator is considered an investigational device in the U.S. and is limited by U.S. law to investigational use only.

1. Thill, M., Ghilli, M., Roncella, M. et al. A Multi-institutional Study to Evaluate the Effectiveness and Safety of a Supine MRI-Based Guidance System, the Breast Cancer Locator^TM, for Breast Conserving Surgery in Patients with Nonpalpable Breast Cancer. Ann Surg Oncol 32, 8636–8643 (2025). https://doi.org/10.1245/s10434-025-17513-4.

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"The BCL System enabled us to map disease extent in unprecedented detail to guide more successful excision more often," said Dr. Jennifer Gass, Women & Infants Hospital.