GLP study confirms the safety and biocompatibility of the Bonevolent® composite

Independent preclinical results show the light-cured composite is safe and well integrated in living bone, supporting Biomedical Bonding’s approach to replacing the metal fracture plate.

Stockholm, Sweden, 18 June 2026. Biomedical Bonding AB (BMB) today announced that an independent, GLP-compliant study has confirmed the safety and biocompatibility of the light-cured composite at the core of its Bonevolent® fracture-fixation platform. The composite was found to be safe and well integrated in living bone, supporting the company’s progress toward use in veterinary medicine and its continued development for human orthopaedic surgery.

The Bonevolent® composite works differently from a conventional metal plate. The surgeon applies a viscous resin from a syringe, shapes it to the fracture, and hardens it with blue light into a solid fixation plate, directly on the bone during surgery. The cured composite has a stiffness of about 6 to 7 gigapascals, far closer to natural bone than the 100 to 200 gigapascals of titanium and steel implants, which is intended to reduce the stress shielding associated with rigid metal hardware. Because the plate is shaped to the fracture rather than selected from a range of pre-formed sizes, the approach also gives surgeons greater freedom to treat each fracture as they find it.

In the study, the composite was compared against a conventional metal plate over 91 days in an established preclinical model. Independent histopathological evaluation found no adverse effects on health or welfare, good integration of the composite with surrounding tissue, and greater adjacent bone outgrowth around the composite. The in vivo work was carried out by JUMISC in Spain, with histopathology by NAMSA in France, under Good Laboratory Practice.

The result adds to a wider programme of GLP biocompatibility testing conducted to the ISO 10993 series, in which cytotoxicity, sensitisation and irritation assessments of the composite all returned negative. Together the data describe a composite with favourable biocompatibility, the common foundation beneath both of BMB’s lead products: AdhFix, which anchors the composite to screws for the veterinary market, and FRAP, which anchors the composite to a bone primer for fully metal-free fixation of human fractures.

For more than a century, fixing a fracture has meant metal,” said Michael Malkoch, Founder and CEO of Biomedical Bonding AB. “This study shows the composite at the heart of our platform is safe and well tolerated in living bone, and that bone grows well around it. It is the foundation for everything we are building, from our veterinary product today toward human orthopaedic surgery.

The research behind the Bonevolent® platform has been supported by Vinnova, Eurostars, Medtech4Health and Swelife.

The findings are preclinical. AdhFix and FRAP are not CE marked or cleared by the US Food and Drug Administration, and the results reported here do not constitute regulatory approval.