RevBio Looked Below the Ocean for a Novel Way to Treat Bone Fractures

RevBio Tetranite Bone Adhesive

With nearly two decades as an engineer in the medical device industry under his belt, Brian Hess, CEO of RevBio and co-inventor of Tetranite bone adhesive technology, has long held a palpable fascination with biomaterials.

“My interest has always been in figuring out how to solve the body’s problems with materials that are very compatible and natural to the body,” said Hess, while recovering from running in the Boston Marathon just two days prior. “There are a lot of medical devices that are improving people’s lives––orthopedic implants, for example, and pacemakers. But I always felt it would be really interesting to have materials that mimic the body, whether it’s the tissue of bone or soft tissue specifically.”

Hess’ obsession with reengineering the body with compatible materials led to the search for an alternative method for repairing bone fractures and defects. RevBio was founded in 2014, but Hess started developing Tetranite before then. While working at Stryker, he received the 2010 Innovator of the Year Award for co-inventing the technology. During his research, he determined that the best biocompatible candidates for the job were calcium phosphates.

“To get these adhesive properties, we realized we needed to kind of think about how to glue things together underwater without using toxic materials,” he said. “We got inspired by nature and found that there are organisms that secrete their own underwater adhesives–mussels, oysters and barnacles on boats, for example.”

Hess and his team determined that applying underwater adhesive properties to medical uses within bone would in all likelihood activate the body’s immunogenic response and become promptly rejected. The solution to this problem came from a very unlikely source.

“We asked, what if we could synthetically reproduce parts of that protein because maybe that would eliminate the foreign body rejection,” Hess said. “And so, we found the sandcastle worm, which is a crazy little organism. These worms create their own adhesive to produce a set of proteins that bind sand grains together.”

They found that the sandcastle worm’s proteins were high in ​​O-Phospho-L-Serine (OPLS), an amino acid. Noting that the body is chock full of amino acids, the building blocks for proteins, the team set out to synthetically produce or acquire OPLS and apply it to fracture repair use.

“That was sort of like the aha moment and the experiment that sort of broke,” Hess said. “We found that when we mixed it with calcium phosphate, it produced a self-setting liquid-to-solid material. It essentially formed a glue that had extremely high tacking properties underwater so that it could adhere to surfaces like metal and bone.”

After learning to reverse engineer the material, Hess and his team discovered that it was indeed biocompatible, a critical feature for human medical use.

“We were not surprised by that because calcium phosphate and amino acids are in our bones,” he said. “We essentially found two materials that are highly biocompatible in the body, but when they reacted in a water-like environment, it produced a glue-like substance that had very high strength. That was a huge aha moment. We did studies on it and found that the material, once in the body, was well tolerated and the body slowly and gradually resorbed it.”

Manufacturing the synthetic is straightforward, fast and requires a relatively low cost of goods, Hess said. The company has the inhouse capability to produce Tetranite, which allows them to make routine changes, like particle size and packaging configurations, to adjust for different clinical applications.

When asked what potential applications Tetranite has for human medical use, Hess described them as being “literally from head to toe” and mentioned uses ranging from traumatic bone injuries to bolstering bone density in older women. The injectable adhesive requires only a small incision to deliver the material, making it a more minimally invasive treatment option than traditional open surgery and providing multiple applications.

While RevBio believes that their novel bone fracture repair technology can be applied to a wide range of medical uses, the company is starting with dental procedures to find the fastest path to bringing their product to market. RevBio’s dental application is currently undergoing human clinical trials.

RevBio is researching potential applications for cranial repair and an injectable glue product for wrist fractures. The company was recently awarded a two-year $2 million Phase II Small Business Innovation Research grant to pursue the treatment of wrist fractures with the technology.

Above are radiographic images before and after the percutaneous injection of Tetranite to fixate a Distal Radius Compression Fracture. The image on the left was taken before the injection of Tetranite. The image on the right was captured approximately two minutes after the injection of Tetranite into the fracture site.

Hess said they are likely facing a premarket approval regulatory pathway for many of their adhesive uses, but they’re also exploring the De Novo route. He predicted it taking anywhere from two to four years for Tetranite to be commercialized for human use. According to the company, there is currently no FDA-approved biomaterial with the adhesive osteoconductive and bioresorbable qualities that Tetranite possesses; therefore, it would be the first commercially available synthetic adhesive bone graft on the market.

Hess noted that with a product as promising and transformative as Tetranite, the challenge is whittling down a lengthy list of possibilities to a select few paths to pursue.

“Our slogan is ‘transforming bone repair,’ ” he said. “We think RevBio is truly going to transform the field and change the way surgeons solve problems for their patients.”

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Patrick McGuire is a BONEZONE Contributor.

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