US-based bone adhesive company RevBio has received approval from the US Food and Drug Administration (FDA) to expand an ongoing clinical trial of its bone adhesive biomaterial Tetranite.
The agency granted the expansion of the company’s trial (NCT06095531) following a demonstration of safety in the first five patients treated with the biomaterial.
Tetranite is primarily used to immediately stabilise and fixate cranial flaps following craniotomy procedures associated with brain surgery. But with the expansion, the FDA has also granted the neuroscience investigators involved in RevBio’s trial to incorporate Tetranite into intradural use cases, including tumour resection surgery and other cranial procedures requiring intentional durotomies.
RevBio’s chief medical officer Dr Kevin T Foley said: “Metal plates and screws can produce radiographic artefacts which make it difficult to accurately interpret patient imaging following surgery.
“Furthermore, traditional cranial flap closure methods do not lead to the full osseous reintegration of the flap with the skull, resulting in issues with flap movement, patient pain, and the potential for post-surgical infection.
“Because Tetranite eliminates radiographic artefacts and results in the osseous union of bone flaps with the surrounding skull, it could become the new standard of care for cranial surgeries.”
In tandem with the FDA’s approval for RevBio’s trial expansion, the Centers for Medicare and Medicaid Services (CMS) has approved Tetranite for medical insurance reimbursement when used to replace metal plates and screws for cranial flap fixation.
With private insurance companies in the US typically providing reimbursement for CMS-approved products, the development means RevBio can now charge hospitals for its product.
RevBio's chief financial and operating officer Grayson Allen commented: “We are pleased to receive reimbursement approval from CMS during our IDE clinical trial.
“This will enable RevBio to establish a price with healthcare providers, which is a very important step in the overall product commercialisation process.”
RevBio received FDA approval to initiate the 20-patient pilot trial to evaluate the safety and efficacy of Tetranite in December 2023. In September 2024, the company received a $2.4m grant from the US National Institutes of Health (NIH) to drive the trial towards completion.
According to GlobalData analysis, the global bone grafts and substitutes market was valued at around $3.17bn in 2023 and is forecast to reach $4.28bn by 2033.
