Cairn Surgical, Inc., an innovative medical technology company striving to make breast cancer surgery more precise, today announced publication in the Annals of Surgical Oncology of results from the BCL Trial, an international, randomized, controlled pivotal trial evaluating its investigational Breast Cancer Locator (BCL™) System versus conventional wire localization (WL).

When all randomized patients were analyzed, the observed overall positive margin rate (when cancer cells remain at the edge of the excision) was lower in the BCL group (14%) than the WL group (21%). The observed re-excision rate (when a second surgery is necessary to remove remaining cancer cells) was lower in the BCL group (13%) compared to the WL group (20%). The observed positive margin rate was lower in the BCL group for all sub-groups that were analyzed. In particular, it was lower in patients with cancers that are traditionally challenging to remove: in patients with ductal carcinoma in situ (DCIS), the observed positive margin rate was 21% in the BCL group vs 53% in the WL group, and in patients with invasive lobular carcinoma (ILC), the observed positive margin rate was 9% in the BCL group vs 26% in the WL group. There was a comparable safety profile between the BCL and WL groups.

The BCL Trial is an international, prospective, multicenter, randomized controlled trial conducted at 23 sites by 44 surgeons in the U.S., Canada, U.K., and Austria comparing the effectiveness and safety of the BCL System versus conventional WL in 418 patients with non-palpable, MRI-visualized invasive breast cancer or DCIS.

Despite decades of imaging advances, surgeons still plan and execute breast-conserving surgery around limited tumor information, using a wire or seeds to guide removal of a three-dimensional, often irregularly-shaped tumor. The result is persistently high positive margin rates, leading to second surgeries in about 20% of all patients,1 which can be double that in challenging cancers.2,3 Repeat surgery leads to added costs, scheduling, and patient anxiety.

The BCL System is designed to transform surgical guidance, from rough identification of the tumor center to a precise delineation of a target resection volume. It is an investigational supine MRI-based guidance system that combines a 3D interactive visualization of the tumor (the Visualizer) with a patient-specific, 3D-printed form that enables surgeons to intraoperatively place bracketing wires around the targeted resection volume – this is designed to translate the precision of diagnostic MRI directly into the operating room.

Pivotal Trial Highlights

  • When all randomized patients were analyzed, the observed positive margin rate was lower in the BCL group (14%) than the WL group (21%).

  • The observed re-excision rate was lower in the BCL group (13%) than the WL group (20%).

  • The observed positive margin rate was lower in the BCL group for all sub-groups that were analyzed.

  • In particular, the observed positive margin rate was lower in patients with DCIS in the BCL group (21%) vs WL group (53%).

  • The observed positive margin rate was lower in patients with invasive lobular carcinoma in the BCL group (9%) vs WL group (26%).

“Positive margins after breast-conserving surgery lead to re-excision, added cost, and a difficult experience for patients. Rates have remained stubbornly high despite consensus guidelines,” said 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. “It was striking to see that in this study the observed positive margin rate was lower across all patient groups treated using the BCL System. These findings suggest that providing surgeons with true 3D spatial guidance derived from a supine MRI holds the promise for potentially improved patient outcomes, particularly for cancers like DCIS and ILC that have historically been challenging to clear.”

“This publication reflects years of clinical development and the participation of surgeons and patients across four countries,” said Cairn Surgical CEO David Danielsen. “The results from this trial demonstrate that a more precise approach to BCS has the potential to improve the lives of women dealing with breast cancer.”

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.

Images of the two components of the Breast Cancer Locator System – the BCL guide and Visualizer – are available at: https://www.dropbox.com/scl/fo/6fn982q5g96n879ltkb7l/AOI6D_Lyu8bBmGc_583hbPc?rlkey=3hw0wjgywlcxn7kmdz2ljwera&st=x8o4b3r2&dl=0

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.

Media gallery

About The Author
Business Wire