Navigating Regulatory Hurdles

Aurevia Supports Biomendex in CE Marking Journey for Adaptos® Ortho Wedge

Biomendex has developed an innovative synthetic bone graft substitute called Adaptos® for orthopedic application. This adaptable bone graft composite holds potential across various indications, including orthopedic, spinal and oral & maxillofacial surgeries.

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Adaptos® requires CE certification and for that, Adaptos® is now evaluated in clinical investigation. Biomendex has chosen Labquality as their CRO partner for their randomized, controlled, multi-center clinical investigation to evaluate Adaptos® Ortho Wedge Bone Graft Substitute, indicated for high tibial osteotomy, a procedure for correcting knee malalignment.

The development of a high-risk class implantable medical device within a heavily regulated environment inevitably presents challenges for the project. Labquality is working on clinical evaluation, monitoring, data management, GDPR compliance and trial master file for Biomendex, thereby supporting the collection of clinical data necessary for market access of this medical device.

“This is an exciting time as our team at Biomendex has successfully advanced towards CE marking by launching this pivotal clinical investigation and is navigating the challenges with Labquality to achieve this significant milestone,” says Biomendex Ltd. CEO Pasi Kankaanpää.

The first site has been opened at Helsinki University Hospital, where also recruiting the first patients is taking place. As the first stage of the investigation proceeds, additional sites will be opened for recruitment.