Cairn Surgical Touts Positive Trial Results for the Breast Cancer Locator System

New study results indicate Cairn Surgical Inc.’s investigational Breast Cancer Locator (BCL) System met its primary endpoint and reported a lower positive margin rate (PMR) across all cancer types when compared to conventional wire localization (WL).

Positive margins (tumor at the edge of the lumpectomy specimen, requiring additional surgery to completely remove the tumor) occur following breast-conserving surgery in about 20% of all patients,¹ and in 30%-40% of patients with DCIS or invasive lobular cancer.^2,3 More than 80% of tumors are irregularly-shaped,⁴ making their margins difficult to precisely define by current conventional means. The BCL System is intended to provide intraoperative guidance to surgeons about tumor shape, size, and location while the patient is in the supine (face-up) position.

“The BCL System provided patient-specific information regarding the unique size, shape, and location of each tumor, derived from supine MRI. Having detailed information about each tumor gave us information we could consider before and during each breast cancer surgery,” said Jennifer Gass, M.D., chief of Surgery, Women & Infants Hospital, professor of Surgery, Obstetrics and Gynecology, The Warren Alpert Medical School of Brown University, and principal BCL trial investigator.

The Breast Cancer Locator trial is an international, randomized controlled study comparing the effectiveness and safety of the BCL versus conventional wire localization in 418 patients with non-palpable invasive breast cancer or DCIS at 23 centers in the United States, Canada, United Kingdom, and Austria.

In the prospective, multicenter trial, the following observations were made in comparing the BCL System to conventional wire localization:

• 32% reduction in PMR across all patients
• 34% reduction in re-excision rate (second surgeries) across all patients
• Comparable safety profile

The Breast Cancer Locator System is designed to enable precise tumor localization and tumor excision by surgeons in the operating room. The BCL is a customized guidance device that is 3D-printed to match the unique shape of a patient’s breast with several ports outlining the unique dimensions of the tumor and a clear margin. At the start of surgery, while the patient is under anesthesia, the BCL is positioned on the patient’s breast, and several bracketing wires are placed in the ports to provide reference points around the tumor to guide the surgeon during excision. The BCL’s foundation is a supine MRI taken at the patient’s hospital with the breast positioned in its surgical (supine) position, which is sent to Cairn Surgical for BCL design and production.

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

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 under review for marketing clearance in the United States.

References
¹ Kim Y, Ganduglia-Cazaban C, Tamirisa N et al. Contemporary analysis of re-excision and conversion to mastectomy rates and associated healthcare costs for women undergoing breast-conserving surgery. Ann Surg Oncol 2024; 31: 3649-3660.
² Langhans L, Jensen M, Talman M, et al. Reoperation rates in ductal carcinoma in situ vs invasive breast cancer after wire-guided breast conserving surgery. JAMA Surg 2017; 152: 378-84.
³ Switalla K, Falade I, Quirarte A et al. Positive margin rates after breast conserving surgery by histologic subtype: a systematic review and meta-analysis evaluating the impact of oncoplastic surgery. Ann Surg Oncol 2025; 32: 4899-4909.
⁴ Byrd, B, Krishnaswamy, V, Jiang, G et. al. The Shape of Breast Cancer, Breast Cancer Res and Treat 2020; 183: 403-410