Tulavi Therapeutics has received a de novo clearance from the FDA for a surgical kit designed to help reduce long-term phantom limb pains among people who have had an amputation.
The Allay nerve cap system includes an absorbable hydrogel that encases the end of a severed nerve, preventing it from developing a neuroma—without another nerve to latch onto, a ball-shaped mass can form as it attempts to regenerate in the months following the procedure.
According to Tulavi, neuromas are the leading cause of residual pain among amputees and three-quarters of patients who have lost a limb report chronic discomfort. While the current standard of care is to remove neuromas surgically or redirect the nerve into other tissues, Allay aims to stop them from growing in the first place.
The company said the surgical deployment of its transparent hydrogel takes less than 10 seconds, as it fills a small mold placed around the tip of an exposed peripheral nerve through a sutureless procedure.
After being set, the hydrogel can slowly dissolve into the body within about eight months, though Tulavi said that rate can be adjusted to match the regeneration profile of specific nerves.
The FDA’s green light opens Allay up to adults ages 22 and older. Tulavi said the nerve cap system resulted in zero neuroma growths and was shown to be safe across six preclinical studies; the approach has not been tested clinically.