Selected by CairnSurgical as Exclusive European Supplier for its 3D Printed Breast Cancer Locator
Innovative Surgical Guide Designed to Reduce the Incidence of Positive Margins After Breast Cancer Surgery
Aarschot, Belgium, and Lebanon, NH USA, April 19, 2022.
Amnovis was selected by CairnSurgical for the additive manufacturing (AM) of its revolutionary Breast Cancer Locator ™ (BCL) for patients in Europe. The BCL is a patient-specific surgical guidance solution designed to assist surgeons in precisely locating and accurately excising breast tumors. CairnSurgical builds on Amnovis, an innovator in contract manufacturing of AM products for medical applications. Amnovis houses the AM expertise and digital processes to successfully respond to stricter regulation and the need for higher speed and flexibility in medical manufacturing.
Today 20 to 25 percent of Breast Conserving Surgery (BCS) procedures fail to achieve clear tumor margins, thus requiring those patients to undergo a second surgery. Re-excision surgeries add costs to the healthcare system and are associated with poorer cosmetic outcomes, more difficult patient recovery, and increased emotional strain for patients. 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.
As the first step in the process, CairnSurgical receives patient supine MRI data, analyzes it to define tumor geometry and location, and uses the data to design the patient-specific BCL™. For patients in Europe, Amnovis fabricates the BCL™ surgical guides using stereolithography 3D printing. The Amnovis founders have a background of producing high-end products using AM since 2008. Today, their competent team operates within a digital manufacturing framework that complies with customer and regulatory requirements. As a result, Amnovis excels in agile manufacturing and on-time delivery.
David Danielsen, CEO CairnSurgical: "We chose Amnovis as our operations partner because we recognized that their expertise in medical device 3D printing and their strong focus on quality systems was the right combination for us to enable the commercial launch of the BCL™ surgical guidance system in Europe. The entire Amnovis team impressed us with their knowledge base, their experience in quality management systems and printing, and their collaborative approach to developing a plan and operations that fits our needs."
Ruben Wauthle, CEO and Co-founder Amnovis: "We are extremely proud to collaborate with CairnSurgical with regards to the BCL™. Innovative AM applications, like this surgical guide, perfectly fit our drive to innovate AM contract manufacturing as a company. We established a comprehensive AM workflow and production platform, which is entirely ISO 13485:2016 certified. Digital process automation enables us to obtain paperless operations and provide full traceability and repeatability to flexibly scale up manufacturing of patient-specific products."
Founded by Peter Mercelis and Ruben Wauthle and based in Aarschot, Belgium, Amnovis is a manufacturing and engineering company that uses innovative additive manufacturing (AM) technologies and materials for high-end applications such as medical devices. As an ISO 13485 certified contract manufacturer, Amnovis offers best-in-class AM technologies and expertise, and paves the way for emerging AM technologies and materials. Digital process automation provides the traceability and repeatability to flexibly scale up manufacturing of products that comply with customer and regulatory requirements.
CairnSurgical, Inc. is a medical device company developing patient-specific surgical guides using patient imaging data and state-of-the-art 3D printing technologies. CairnSurgical’s Breast Cancer Locator (BCL) System enables 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. The BCL is a custom device under EU MDR regulations and is available for commercial use in the EU.