Tulavi's allay™ Hydrogel Cap represents a major advancement as it is the first and only fully absorbable, in situ forming technology designed to protect transected nerves, block axonal escape, and reduce the risk of neuroma formation. By offering surgeons a practical and cost-effective surgical option, Tulavi aims to improve patient outcomes and drive more procedures to hospitals. This innovation provides a solution for traumatic amputations and addresses the prevalent population of neuroma patients.
The allay™ hydrogel cap received De Novo classification from the FDA in July 2024, indicating a category first in peripheral nerve surgery. It is an in situ forming adaptive hydrogel designed to protect transected nerves and reduce the risk of neuroma formation. The allay™ hydrogel cap acts as a physical barrier that securely conforms to the end of the nerve, blocking axonal escape and exhausting axon growth to prevent neuromas from forming. The formed hydrogel is comprised of approximately 90% water and is a transparent, semipermeable and compliant nerve cover that conforms to and provides non-constricting encasement of the nerve. The hydrogel permits the exchange of nutrients and oxygen through the material but acts as a barrier to inflammatory cells reducing the foreign body response around the nerve. The hydrogel persists in the body for 8 months, well past the neuroma formation window, and is then absorbed via hydrolysis.