ISO 13485 Certification Awarded to Cairn Surgical

Cairn Surgical Inc. has earned ISO 13485:2016 certification for its quality management system associated with the Breast Cancer Locator (BCL) System. ISO 13485 is the international standard for quality management systems in the medical device industry.

“ISO certification is an important step in the evolution of the company as we look towards broader commercialization of the BCL System in Europe and entrance into new regions,” Cairn Surgical CEO David Danielsen said. “It demonstrates not only our commitment to product quality, but also our ability to achieve it consistently across the design, development and manufacturing of our BCL System, and compliance with all applicable regulatory requirements. We look forward to the momentum this milestone will bring to our regulatory and market access efforts.”

The BCL System aims to improve the accuracy of breast conserving surgery (lumpectomy) by providing precise guidance regarding tumor shape, size, and location. The detailed information—which traditional wire localization or other methods cannot provide—is intended to enable surgeons to achieve clear margins.

The two components of the BCL System are created from a supine MRI of the patient’s breast, with the breast positioned in its surgical position for greatest accuracy. A customized 3D-printed form—the BCL— is produced that fits the unique shape of a patient’s breast and marks the tumor’s boundaries. An interactive, real-time image of the tumor in the breast is also produced (the Visualizer) providing a detailed, 3D view of the tumor within the breast. During surgery, the two technologies are used concurrently by a surgeon to provide invaluable references during tumor excision.

The company’s U.S. pivotal trial of the BCL System is expected to be completed later this year.

Cairn Surgical is developing surgical guidance technology for breast conserving surgery customized by patient using patient imaging data and state-of-the-art 3D printing. The company’s Breast Cancer Locator (BCL) System is designed to enable precise tumor localization and excision. It is commercially available in Europe and currently being studied in a U.S. pivotal trial.

The Breast Cancer Locator is an investigational device in the United States and is limited by federal law to investigational use only.