Cairn Surgical, Inc., an innovative medical technology firm striving to make breast cancer surgery more precise, announced that the first commercial case using its Breast Cancer Locator (BCL) System has been performed by Prof. Dr. med. Hisham Fansa, head of the Breast Center and head of plastic surgery at Spital Zollikerberg, Zürich, Switzerland. The BCL System is designed to improve the accuracy of breast conserving surgery (lumpectomy) by providing precise guidance regarding tumor shape, size, and location, thus enabling the ability to achieve clear margins.
“Having previously participated in clinical studies of the BCL with excellent outcomes, we were pleased to see that in this first commercial case we achieved a negative margin indicating no detectable cancer after tumor removal,” said Prof. Dr. med Fansa. “Having this breakthrough technology now available for breast conserving surgery at our center will provide us with personalized and detailed information about each tumor, uniquely based on the patient’s supine surgical position. This invaluable data offers the promise to enhance outcomes for our patients and potentially save them from second surgeries to completely remove their tumor.
“We are excited to kickoff commercialization of the BCL in our first targeted region of Europe, which will give breast surgeons detailed information and 360° views of each tumor that they have never before experienced,” said Cairn Surgical CEO David Danielsen. “It is gratifying that our vision of providing breast surgeons with a valuable tool to enhance their precision and outcomes has become a reality. We look forward to completing our U.S. pivotal trial to further build the body of evidence supporting the BCL, which will enable us to expand access to this important technology.”
The BCL System is designed to reduce positive margin rates and to improve the workflow of breast conserving surgery. A supine MRI with the breast positioned in its surgical position for greatest accuracy is first performed, with the image transformed into a customized 3D-printed form – the BCL – that uniquely fits the shape of the patient’s breast and guides the surgeon to the precise location and dimensions of the tumor. During surgery, the BCL and the Visualizer – an interactive, real-time, 3D image of the tumor in the breast – are used by the surgeon to provide valuable references during tumor excision.
Clinical data from a multicenter European post-market surveillance clinical study of 33 patients is expected to be presented in a clinical forum later this year. In earlier clinical studies of the BCL System, published in the Annals of Surgical Oncology and in Surgical Oncology, clear tumor margins were achieved in all patients. Resection volumes were comparable to target resection volumes determined by tumor modeling based on the supine MRI.
The U.S. pivotal trial of 448 women treated with the Breast Cancer Locator (BCL) System at up to 25 centers is currently enrolling patients and is designed to support FDA clearance and U.S. commercialization. The primary endpoint is positive margin rate, with other endpoints including specimen volumes, rate of additional shave biopsies, re-excision rate, cancer localization rate, operative time, and cost of care.
