RevBio^® Receives First FDA Approval for a "Bone Glue" to Treat Extremity Fractures in a Clinical Trial

LOWELL, Mass.--(BUSINESS WIRE)--RevBio^® announced today that TETRANITE, the company’s first of its kind regenerative “bone glue” has been approved for a 20-patient pilot study to measure the biomaterial’s safety and efficacy to treat complex, multi-fragmented wrist fractures including those that involve articular surfaces.

“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.

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The focus of this clinical trial will be on the ability for the patented TETRANITE technology to fill gaps in bone, fixate bone fragments, and accelerate healing through its osteoconductive capabilities for fractures in the extremities. TETRANITE will be used both as an interoperative fixation aid and as an adjunct to traditional hardware fixation to provide immediate load sharing between bone and metal plate and screw systems. TETRANITE’s adhesive bond strength to bone, which exceeds 2MPa in sheer and 30MPa in compression, has been evidenced through rigorous biomechanical testing and published in peer reviewed journal articles. By providing additional stability and regenerating bone where bone has been lost, TETRANITE will help achieve better healing and prevent complications and revision surgeries. TETRANITE was evidenced for its capacity 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 orthopaedic trauma procedures will be performed when this product attains commercial approval.”

Falls from standing height and other low-energy trauma account for 87% of all orthopaedic fractures among the elderly. External fixation, percutaneous pinning with K-wires, and conventional open reduction internal fixation (ORIF) procedures that involve the use of locking plates are interventions that are currently being used to treat extremity fractures. However, despite advances in surgical technique and implant design, nonunion, malunion, and hardware failure continue to remain a significant cause of revision surgery in the elderly.¹ Complication rates as high as 36% have been reported and involve onset of carpal tunnel syndrome, complex regional pain syndrome, tendon irritation and rupture, and deep infection.^2,3 These complications lead to difficulty performing basic daily tasks, loss of independence, reduction in quality of life, and increased mortality.

“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. Dr. Jupiter is an internationally known hand and upper limb specialist who has given more than 1000 scientific presentations, published more than 220 original publications, 140 analytic reviews, 115 chapters in scientific texts and was co-author or co-editor of 10 major texts in upper limb and orthopaedic problems. “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.”

About RevBio, Inc.

RevBio, Inc., is a clinical stage medical device company in metropolitan Boston, that has invented TETRANITE^®, a regenerative bone glue currently in human patients across ten FDA approved clinical trials. Recognized as a novel technology, TETRANITE is anticipated to receive De Novo classification for several key indications which will expedite its path to commercialization. TETRANITE has demonstrated superior clinical performance over current standards of care including curing speed, shear forces, rate of bone regeneration, and wet-field adhesion. Bioengineered for a body of applications, the TETRANITE platform will address a total addressable market of over $10 billion in neurosurgical, orthopaedic and dental use cases. RevBio's TETRANITE technology is not yet approved for commercial use.