RevBio announced that its TETRANITE regenerative bone glue has been approved by the U.S. Food and Drug Administration (FDA) for a 20-patient pilot study to measure the material’s safety and efficacy to treat complex, multi-fragmented wrist fractures, including those that involve articular surfaces.

The trial’s focus will be on TETRANITE’s ability to fill gaps in bone, fixate bone fragments, and speed healing through its osteoconductive capabilities for fractures in the extremities. It will be used as both an interoperative fixation aid and an adjunct to traditional hardware fixation to offer immediate load sharing between bone and metal plate and screw systems.

TETRANITE’s adhesive bond strength to bone exceeds 2MPa in sheer and 20MPa in compression. It’s been studied in rigorous biomechanical testing and published in peer-reviewed journal articles.

By offering further stability and regenerating bone where it’s been lost, the material aims to help achieve better healing and prevent complications and revision surgeries. TETRANITE was evidence for its ability to regenerate 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 revolutionize how complex orthopedic trauma procedures will be performed when this product attains commercial approval.”

Last month, RevBio was awarded a $2.2 billion NIH grant to advance TETRANITE for use in minimally invasive spine fracture treatment.

“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 Hansjorg Wyss AO professor of orthopedic surgery at Harvard Medical School, and advisor 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.”