Cairn Surgical, Inc. Announces Pivotal Trial Success for Breast Cancer Locator System, Demonstrating Improved Surgical Outcomes
Cairn Surgical, Inc., a medical technology innovator focused on improving precision in breast cancer surgery, has announced encouraging results from its pivotal clinical trial evaluating the investigational Breast Cancer Locator (BCL™) System. The findings, presented at the annual meeting of the American Society of Breast Surgeons (ASBrS), highlight the system’s potential to significantly enhance surgical accuracy and reduce the need for repeat procedures.
The study successfully met its primary endpoint, demonstrating a meaningful reduction in positive margin rates (PMR)—a key measure in breast-conserving surgery indicating whether cancerous tissue remains after tumor removal. Compared to conventional wire localization (WL), the BCL System showed improved outcomes across all cancer types included in the trial.
Significant Improvements in Surgical Outcomes
Among the most notable findings from the study was a 32% reduction in positive margin rates across all patients treated using the BCL System. Positive margins occur when cancer cells are detected at the edge of the removed tissue, suggesting that some tumor may have been left behind. This often necessitates additional surgery, increasing both patient burden and healthcare costs.
In addition, the trial reported a 34% reduction in re-excision rates, meaning fewer patients required follow-up surgeries to remove residual cancerous tissue. These findings are particularly important, as repeat procedures can delay recovery, increase emotional stress, and elevate the risk of complications.
Addressing a Persistent Challenge in Breast-Conserving Surgery
Breast-conserving surgery, also known as lumpectomy, aims to remove cancer while preserving as much healthy breast tissue as possible. However, achieving clear margins remains a persistent challenge. Current estimates suggest that positive margins occur in approximately 20% of all breast-conserving surgeries. This rate is even higher—between 30% and 40%—in patients with ductal carcinoma in situ (DCIS) or invasive lobular carcinoma.
One of the reasons for this challenge lies in the nature of breast tumors. More than 80% of tumors are irregularly shaped, making it difficult for surgeons to accurately determine their boundaries using conventional localization methods such as wire placement. Traditional techniques often rely on imaging performed while the patient is in a different position than during surgery, which can lead to discrepancies in tumor location.
How the BCL System Enhances Precision
The Breast Cancer Locator (BCL™) System is designed to address these limitations by providing surgeons with detailed, patient-specific information about the tumor’s size, shape, and location. Unlike traditional methods, the BCL System uses imaging acquired while the patient is in the supine (face-up) position, which closely matches the surgical setting.
This alignment allows for more accurate intraoperative guidance, helping surgeons better visualize the tumor and its margins during the procedure. By incorporating advanced imaging data into surgical planning and execution, the system aims to improve precision and reduce the likelihood of leaving behind cancerous tissue.
Expert Insights from the Trial
Leading the clinical investigation was Jennifer Gass, MD, Chief of Surgery at Women & Infants Hospital and a professor at The Warren Alpert Medical School of Brown University. As the principal investigator of the BCL Trial, Dr. Gass emphasized the value of personalized imaging data in surgical decision-making.
According to Dr. Gass, the BCL System provided surgeons with detailed insights into each patient’s tumor characteristics, including its unique shape and spatial orientation. This information was available both before and during surgery, enabling a more informed and tailored approach to tumor removal.
She noted that having access to such precise data represents a meaningful advancement over conventional methods, which often rely on less detailed or less accurately aligned imaging.
Trial Design and Scope
The BCL Trial was a prospective, multicenter, randomized controlled study, widely regarded as the gold standard in clinical research. It included 418 patients diagnosed with non-palpable invasive breast cancer or DCIS. These patients were treated across 23 medical centers located in the United States, Canada, the United Kingdom, and Austria.
Participants were randomly assigned to undergo tumor localization using either the BCL System or traditional wire localization. The study compared both the effectiveness and safety of the two approaches.
Key Findings from the Trial
The trial yielded several important observations:
- A 32% reduction in positive margin rates among patients treated with the BCL System
- A 34% decrease in re-excision rates, reducing the need for additional surgeries
- A safety profile comparable to conventional wire localization methods
These results suggest that the BCL System not only improves surgical accuracy but does so without introducing additional safety risks.
Implications for Patients and Healthcare Systems
The ability to reduce positive margins and re-excision rates has significant implications. For patients, fewer surgeries mean less physical and emotional stress, shorter recovery times, and improved overall quality of life. For healthcare providers, it translates into more efficient use of resources and potentially lower costs.
Moreover, improving surgical precision may contribute to better long-term outcomes, including reduced recurrence rates, although further studies would be needed to confirm this.
Presentation at ASBrS Annual Meeting
The results of the pivotal trial were presented during the annual meeting of the American Society of Breast Surgeons, a leading forum for advancements in breast surgery. Clinical investigators are also scheduled to discuss the findings in greater detail during a sponsored symposium held on May 2 in Seattle.
This presentation provides an opportunity for surgeons, researchers, and healthcare professionals to explore the potential impact of the BCL System on clinical practice and to engage in discussions about its future adoption.
The promising results from this pivotal trial position the Breast Cancer Locator System as a potentially transformative tool in breast cancer surgery. By addressing longstanding challenges associated with tumor localization, the technology could help set a new standard for precision in breast-conserving procedures.
As the medical community continues to seek ways to improve outcomes and reduce the burden of cancer treatment, innovations like the BCL System underscore the importance of integrating advanced imaging and personalized data into surgical care.
Further regulatory review and real-world implementation will determine how quickly and widely this technology becomes available. However, the current evidence suggests that it could play a significant role in shaping the future of breast cancer treatment.
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
