RevBio has FDA approval to start a 20-patient pilot testing Tetranite “bone glue” in complex wrist fractures.
The study will assess safety and efficacy in multi-fragment wrist fractures, including those involving joint surfaces. Tetranite is osteoconductive, meaning it supports new bone growth along its surface.
RevBio says Tetranite can fill gaps, fix fragments and work alongside plates and screws to share load during healing. It will be used during surgery as a fixation aid and adjunct to standard hardware.
According to the company, biomechanical testing shows adhesive bond strength to bone exceeding 2 MPa in shear and 30 MPa in compression. The material also regenerated bone in an experiment on the International Space Station.
“TETRANITE has all the requisite properties that we thought the next generation bone restoration products would have, including the combination of adhesion and resorption,” said Rick Gennett, former president of Synthes Trauma Inc. “This product will revolutionise how complex orthopaedic trauma procedures will be performed when this product attains commercial approval.”
Low-energy falls account for a large share of fractures in older adults. While external fixation, K-wires and open reduction internal fixation are widely used, nonunion, malunion and hardware failure still drive revision surgery. Reported complication rates reach 36 per cent.
“Having used TETRANITE in pre-clinical testing, I am extremely impressed that RevBio has been able to create the first superglue for bone repair,” said Jesse B. Jupiter, MD, former Hansjörg Wyss AO professor of orthopaedic surgery at Harvard Medical School and adviser to RevBio. “Throughout my entire career, the orthopaedic surgeon community and I have long sought a solution to give patients with such complex fractures faster and more predictable recovery.”
RevBio describes itself as a clinical-stage device company. It says Tetranite is being evaluated in human patients across ten FDA-approved clinical trials and is anticipated to seek De Novo classification for several indications. Tetranite is not approved for commercial use.”
