Tampere, Finland — 18-Feb, 2026

Biomendex today announced that Adaptos® Fuse Bone Graft has received U.S. Food and Drug Administration (FDA) 510(k) clearance as a bone graft substitute for filling bony voids or gaps that are not intrinsic to the stability of the bony structure. This clearance marks Biomendex’s entry into the U.S. bone graft substitute market.

This milestone represents the first FDA clearance for human clinical use of Biomendex’s proprietary bone regeneration platform technology. The platform has previously been utilized in more than 2,700 veterinary orthopedic and dental procedures, providing extensive real-world surgical experience prior to its introduction into human clinical practice.

Positioned for U.S. Market Entry

Adaptos® Fuse is indicated for use in surgically created osseous defects and defects resulting from traumatic injury, including indications such as posterolateral spine, intervertebral disc space, and pelvis. In interbody fusion procedures, Adaptos®Fuse Bone Graft must be used with interbody fusion devices FDA cleared for use with bone void filler. The material is designed to resorb over time and be replaced by bone during the natural healing process.

Adaptos® Fuse has been engineered to integrate into standard surgical techniques, with handling characteristics intended to support intraoperative efficiency. Its design also supports robust combination with autograft and postoperative imaging visibility, an important consideration in clinical follow-up.

“FDA 510(k) clearance of Adaptos® Fuse marks a transformational milestone for Biomendex” said Pasi Kankaanpää, CEO of Biomendex. “We are now positioned to enter the U.S. market with a scalable synthetic bone graft solution built on years of platform development and veterinary clinical experience.This clearance validates our technology and establishes a foundation for commercial growth in spine applications.”

Commercialization Strategy

Biomendex plans to initiate phased U.S. commercialization in accordance with cleared labeling, focusing on targeted spine segments. The company is advancing distribution and partnership discussions to support market entry and drive adoption among qualified healthcare professionals trained in appropriate surgical techniques.

About Biomendex

Biomendex is a medical technology company focused on the development of regenerative biomaterials designed to support bone healing in orthopedic and dental applications. The company’s technology platform has been utilized in veterinary surgical practice and is now cleared for human clinical use in the United States.

Forward-Looking Statements

This press release contains forward-looking statements regarding commercialization, clinical adoption, growth strategy and anticipated use. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. Biomendex undertakes no obligation to update forward-looking statements except as required by applicable law.