Amnovis/ ClairnSurgical
Contract additive manufacturing firm Amnovis has been selected by ClairnSurgical to produce its patient-specific Breast Cancer Locator (BCL) product in Europe.
The surgical guidance product has been designed to help surgeons precisely locate and excise breast tumours.
ClairnSurgical designed and developed the BCL product to address the 20-25% of Breast Conserving Surgery procedures that fail to achieve clear tumour margins, resulting in secondary procedures that hinder patient recovery and add costs to the healthcare system. With the BCL, ClairnSurgical says the accuracy of breast conserving surgery is improved by providing precise guidance regarding tumour shape, size and location.
The development of BCL devices starts with the MRI data of the patient, which is analysed to define tumour geometry and location before the product is designed. For BCL products in Europe, Amnovis will then process this design on a Stereolithography 3D printing system. Amnovis was founded in 2020 and boasts a team with more than 35 years of experience in additive manufacturing. Last year, the company achieved ISO 13485 certification thanks in part to Oqton's manufacturing execution system capabilities.
“We chose Amnovis as our operations partner because we recognised 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,” commented David Danielsen, CEO of ClairnSurgical. “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.”
“We are extremely proud to collaborate with ClairnSurgical with regards to BCL,” added Ruben Wauthle, CEO and co-founder of Amnovis. “Innovative AM applications like this surgical guide, perfectly fit our drive to innovative 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.”
