SEATTLE–(BUSINESS WIRE)–#BCSM—Cairn Surgical, Inc., an innovative medical technology company striving to make breast cancer surgery more precise, announced today the results of its pivotal trial evaluating its investigational Breast Cancer Locator (BCLTM) System. The study met its primary endpoint and reported a lower positive margin rate (PMR) across all cancer types when compared to conventional wire localization (WL). Results were presented at the annual meeting of the American Society of Breast Surgeons (ASBrS) currently underway in Seattle.
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 today’s conventional means. The BCL System is intended to provide intraoperative guidance to surgeons regarding tumor shape, size, and location while the patient is in the supine (face-up) position for surgery.
Jennifer Gass, MD, Chief of Surgery, Women & Infants Hospital, Professor of Surgery, Obstetrics and Gynecology, The Warren Alpert Medical School of Brown University, and Principal Investigator of the BCL Trial, commented, “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.”
Pivotal Trial Highlights
The Breast Cancer Locator (BCL) Trial is an international, prospective, multicenter, randomized controlled trial 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 U.S., Canada, U.K., and Austria.
In the pivotal 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
Clinical investigators will be discussing the pivotal trial results in a sponsored symposium at the ASBrS meeting on Saturday, May 2, from 6:15 am-7:45 am PDT in the Arch building, Rooms 608-610. RSVP for the symposium here.
About the Breast Cancer Locator System
The Breast Cancer Locator (BCL) 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 a 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 foundation of the BCL 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.
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 under review for marketing clearance in the U.S.
References
- 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.
- 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.
- 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.
- Byrd, B, Krishnaswamy, V, Jiang, G et. al. The Shape of Breast Cancer, Breast Cancer Res and Treat 2020; 183: 403-410
Contacts
MEDIA CONTACT:
Michelle McAdam, Chronic Communications, Inc.
[email protected], (310) 902-1274
