(r.a. paterson, Flickr. https://www.flickr.com/photos/bcpaterson/7992576060)
7 Apr. 2021. A company developing a biocompatible material to aid bone healing will test the substance on treating simulated wrist fractures in large animals. The study by RevBio Inc. in Lowell, Massachusetts is funded by a two-year, $2 million grant from National Institute on Aging, part of National Institutes of Health, under NIH’s Small Business Innovation Research program.
RevBio is developer of a material called tetranite, a biocompatible adhesive designed to join bone to other bone or metal. Tetranite is made of tetracalcium phosphate, a naturally-occurring mineral used in bone cements, and the amino acid O-Phospho-L-serine used to express and purify proteins. The material is injected as a liquid, which then cures and sets as it hardens. Tetranite forms into an amorphous solid allowing for growth of natural bone tissue and blood vessels, which takes over the fracture site, as the tetranite is progressively resorbed.
The most advanced applications of tetranite are to stabilize dental implants and dental bone grafts for humans and animals, both in clinical trials. The new application is to help heal distal radius fractures. The distal radius is a bone in the forearm connecting to the wrist joint. Fractures in the distal radius are quite common, often from falling on an outstretched hand.
RevBio cites data showing some 675,000 distal radius fractures occur in the U.S. each year, particularly to older adults. Treating the fracture requires an external cast or surgery with metal plates or screws to immobilize the bone to allow healing. The company cites other data showing 36 percent of existing fixation techniques result in complications, which can be painful.
Demonstrate a minimally invasive process
In an earlier NIH-funded project, the company demonstrated technical feasibility of treating hand and arm bone fractures with tetranite. In the new project, RevBio plans to refine the process for injecting tetranite under the skin to deposit the material at the site of the fracture. With this procedure, says RevBio, tetranite can be administered with a small incision as minimally invasive surgery.
The company also plans to test the process and material on bone breaks similar to distal radius fractures in large animals. Results of these tests and further simulations with cadavers are expected to provide evidence to request an investigational device exemption from Food and Drug Administration, in effect a request to begin clinical trials.
“This opportunity really showcases the reason we invented this product, to provide surgeons with a first ever regenerative bone adhesive,” says Brian Hess, CEO of RevBio in a company statement released through Cision. “This is the first of many indications we intend to launch to revolutionize how bone fractures are treated.”
The grant is awarded under NIH’s Small Business Innovation Research, or SBIR, program that sets aside a portion of its overall research funding for small U.S.-based companies with science-based products. NIH says it invests more than $1 billion in SBIR and related awards. Most SBIR awards like this one to RevBio are awarded to two parts, first to show feasibility, then to develop a working prototype.
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