RevBio, Inc., a bone adhesive company, has secured FDA approval to broaden its ongoing clinical trial (NCT06095531) of Tetranite, a bone adhesive biomaterial, following successful safety demonstrations in the first five patients. This expansion allows for the evaluation of Tetranite in a wider range of cranial procedures.
Expanding Clinical Applications of Tetranite
Originally, the pilot trial, initiated in December 2023, focused on using Tetranite to stabilize cranial flaps after craniotomy procedures. The FDA's approval now extends the trial to include intradural applications, such as tumor resection surgeries and other cranial procedures necessitating intentional durotomies. This expansion significantly broadens the potential clinical utility of Tetranite.
Eliminating Artifacts and Promoting Osseous Integration
Dr. Kevin T. Foley, Chief Medical Officer at RevBio, highlighted the limitations of traditional methods involving metal plates and screws, which can cause radiographic artifacts, complicating postoperative imaging interpretation. He also noted that these methods often fail to achieve full osseous reintegration of the flap with the skull, potentially leading to flap movement, patient discomfort, and increased risk of infection. Dr. Foley stated, "Because Tetranite eliminates radiographic artifacts and results in osseous union of bone flaps with the surrounding skull, it could become the new standard of care for cranial surgeries."
CMS Reimbursement Approval
In addition to the FDA's trial expansion approval, the Centers for Medicare and Medicaid Services (CMS) has approved Tetranite for medical insurance reimbursement when used as a substitute for metal plates and screws in cranial flap fixation. This decision is significant because private insurance companies typically follow CMS guidelines for reimbursement, allowing RevBio to bill hospitals for the product. Grayson Allen, CFO/COO of RevBio, 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 commercialization process."
Market Context
According to GlobalData analysis, the global bone grafts and substitutes market was valued at approximately $3.17 billion in 2023 and is projected to reach $4.28 billion by 2033, indicating a substantial market opportunity for innovative bone adhesives like Tetranite. RevBio received a $2.4 million grant from the NIH in September 2024 to support the completion of the trial.
