LEBANON, N.H.--(BUSINESS WIRE)--Cairn Surgical, Inc., an innovative medical technology firm striving to make breast cancer surgery more precise, announced today that patient enrollment has been completed in its European post-market clinical study of the Breast Cancer Locator (BCLTM) System. 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.
“In this study, the Breast Cancer Locator exceeded our expectations in enabling us to achieve negative margins, which is what we strive for in every case,” said Prof. Dr. med. Marc Thill, Chief of Gynecology and Gynecologic Cancer at Agaplesion Markus Krankenhaus, Frankfurt, Germany, and clinical investigator in the study. “It is clear that having detailed guidance regarding the size, shape and location of each tumor in the supine position enables us to improve our surgical outcomes.”
“The combination of the patient-specific Breast Cancer Locator and the real-time VisualizerTM was intuitive to use and provided us with interactive multi-angle views of the tumor,” said Prof. Dr. Michael Golatta, Brustzentrum Heidelberg, Klinik Sankt Elisabeth, Heidelberg, Germany, clinical investigator in the study.
The multicenter European post-market surveillance clinical study encompassed 33 patients who underwent breast conserving surgery to remove a breast tumor using the BCL System, per protocol. Patients were treated at five centers, including Santa Chiara Hospital in Pisa, Italy; Spital Zollikerberg in Zollikerberg, Switzerland; Humanitas Research Hospital in Rozanno, Italy; Klinik Sankt Elizabeth in Heidelberg, Germany; and Agaplesion Markus Krankenhaus in Frankfurt, Germany. The primary endpoint is positive margin rate, which is assessed by imaging and pathology immediately following the procedure. Clinical data from the study 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 Oncology1 and in Surgical Oncology2, 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.1,2
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 a customized 3D-printed form – the BCL – designed and produced from the image to fit the unique shape of that patient’s breast. 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.
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.
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 being studied in a U.S. pivotal trial. Cairn Surgical’s Breast Cancer Locator (BCL) System is designed to enable precise tumor localization and excision.
The Breast Cancer Locator is considered an investigational device in the U.S. and is limited by U.S. law to investigational use only.
1. Barth RJ, Krishnaswamy V, Paulsen KD, et al. A patient-specific 3D-printed form accurately transfers supine MRI-derived tumor localization information to guide breast-conserving surgery. Ann Surg Oncol. 2017; 24(10): 2950-2956.
2. Barth RJ, Krishnaswamy V, Rooney T, et al. A pilot multi-institutional study to evaluate the accuracy of a supine MRI based guidance system, the Breast Cancer Locator™, in patients with palpable breast cancer. Surgical Oncology, Vol 44, September 2022, 101843.
