RevBio receives FDA approval for trial of cranial bone glue
US-based bone adhesive firm RevBio has obtained approval from the Meals and Drug Administration (FDA) for an experimental machine exemption (IDE) to conduct a medical trial of its cranium flap bone adhesive.
The randomized, managed, pivotal, multicenter research will consider the corporate’s Tetranite for reintegrating cranial bone valves throughout mind surgical procedure.
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The T-RESTORE II research will contain as much as 204 sufferers. Half of them will obtain tetranite remedy, whereas the opposite half will obtain typical cranium plate and screw fixation.
These procedures are usually carried out throughout craniotomy surgical procedures for situations reminiscent of aneurysm remedy, mind tumor elimination, deep mind stimulation, or intracranial stress reduction. A rating line is created when a part of the cranium is eliminated and later reattached, however present strategies don’t fill or seal this hole.
Tetranite acts as a regenerative bone adhesive utilized inside the rating line, which is created when a part of the cranium is eliminated and later reattached, however present strategies don’t fill or seal this hole.
The remedy instantly units the bone flap in place, filling the house between the flap and the cranium and making a organic pathway for bone cells.
This will help improved fusion and therapeutic of the cranium flap, doubtlessly addressing issues reminiscent of cerebrospinal fluid leaks and diminished stability, recognized limitations of plate and screw methods.
The FDA has approved as much as 15 medical websites to take part within the research. RevBio is within the course of of choosing these areas in collaboration with the members of the neurosurgical advisory board.
The IDE approval was granted following favorable outcomes from pivotal preclinical research, surgeon evaluations and the earlier medical pilot research (T-RESTORE I).
Brian Hess, CEO and Founding father of RevBio, mentioned: “This pivotal IDE research permits us to conduct the ultimate testing required for industrial approval of our lead indication within the $10 billion focused bone adhesive purposes market. The truth that RevBio now has two lively pivotal section applications underlines our capacity to scale this expertise as a platform.”
In December 2024, RevBio obtained FDA approval to develop an ongoing medical trial of Tetranite.
