Cairn Surgical, Inc., a medical technology company focused on advancing breast cancer surgery, announced today the completion of patient enrollment in its U.S. pivotal trial for the Breast Cancer Locator (BCL™) System. The system is designed to enhance the precision of breast-conserving surgery, providing surgeons with detailed guidance on tumor size, shape, and location to improve the likelihood of clear surgical margins.
“The BCL System enabled us to map disease extent in unprecedented detail, guiding more successful excisions more often,” said Dr. Jennifer Gass, Principal Investigator of the BCL study, Chief of Surgery at Women & Infants Hospital, and Professor of Surgery at The Warren Alpert Medical School of Brown University. “We are very pleased with the BCL’s performance and the results observed in this large, randomized controlled trial.”
The BCL Study is a prospective, multicenter, 1:1 randomized controlled trial involving women with non-palpable invasive breast cancer or ductal carcinoma in situ (DCIS). Participants were assigned to either the BCL System or standard wire localization to guide surgery. The trial’s primary endpoint is the rate of positive margins, with additional endpoints including specimen volumes, additional shave biopsies, re-excision rates, tumor localization success, operative time, and overall cost of care.
Supporting its clinical promise, a European study published in Annals of Surgical Oncology in November 2025 reported that the BCL System enabled surgeons to achieve negative margins in 94% of patients, without additional shave margins during initial surgery. The study also showed that surgeons removed less tissue compared with traditional approaches, resulting in higher patient satisfaction with postoperative breast appearance. Over 90% of surgeons involved expressed satisfaction with the BCL System.
“Our goal is to provide a more accurate map of cancer extent, helping women avoid repeat surgeries to remove residual tumors,” said Dr. Richard Barth Jr., Chief of General Surgery at Dartmouth-Hitchcock Medical Center, Professor of Surgery at the Geisel School of Medicine at Dartmouth, and Cairn Surgical co-founder. “The detailed tumor information provided by the BCL System is designed to improve surgical precision and achieve negative margins, leaving no detectable cancer behind. Completing our U.S. clinical trial is a major step toward giving physicians and patients a better way to treat breast cancer.”
The BCL System employs a supine MRI with the breast positioned for surgery to produce a customized 3D-printed guide tailored to each patient. During surgery, this guide, along with the Visualizer—a real-time 3D interactive image of the tumor—assists surgeons in accurately excising the tumor while preserving healthy tissue.
Cairn Surgical plans to submit the trial results and related data to the FDA in the coming weeks.
About Cairn Surgical
Cairn Surgical, Inc. develops patient-specific surgical guides using advanced imaging and 3D printing technologies. Its Breast Cancer Locator (BCL) System, commercially available in Europe and under study in the U.S., aims to enable precise tumor localization and excision. In the United States, the BCL is considered an investigational device and is limited by law to investigational use only.
