The U.S. FDA granted accelerated approval for the Biologics License Application for Axogen Inc.'s Avance, an acellular nerve allograft that serves as a scaffold for nerve regrowth, for treatment of patients with sensory, mixed and motor peripheral nerve discontinuities. The company expects Avance to be commercially available in the second quarter of 2026.
The U.S. FDA has cleared regenerative medicine company Orthocell Ltd.’s 510(k) for its nerve repair product, Remplir, paving the way to begin commercial operations in the $1.6 billion U.S. nerve repair market.
Regenerative medicine company Orthocell Ltd. raised AU$17 million (US$11.28 million) to launch its nerve repair product, Remplir, in the $1.6 billion U.S. market.
Regenerative medicine company Orthocell Ltd. raised AU$17 million (US$11.28 million) to launch its nerve repair product, Remplir, in the $1.6 billion U.S. market.
Regenerative medicine company Orthocell Ltd.’s nerve repair product, Remplir, was approved by Singapore’s Health Sciences Authority, opening up the Asian market for the company’s biggest product.
A meta-analysis found no difference in outcomes between autograft nerve repair and repair using Axogen Inc.’s Avance nerve grafts across all types of nerves and gap lengths up to 70 millimeters. Axogen’s allograft nerves allow patients to avoid the potential complications associated with harvesting the individual’s own nerve to use in repair. The study was published in Plastic and Reconstructive Surgery in January.
With top line results from its major phase III RECON study in hand, Axogen Inc. is hoping to expand adoption of its allograft nerve repair product Avance. RECON was designed as a non-inferiority study comparing Avance to nerve cuffs (manufactured conduits) which are commercially available. The study met its primary endpoint for the return of sensory function as measured by static two-point discrimination, and the safety profile was consistent with previously published data.
Regenerative medicine company Orthocell Ltd. reported final data from its nerve reconstruction study that showed patients continued to improve between 12- and 24-months post-treatment with regenerative nerve repair device Remplir.
Biocircuit Technologies Inc. has joined forces with Smithfield Bioscience Inc. to scale up a medical alternative to sutures for repairing nerves on the peripheral side of the body damaged in an accident or during surgery. Nerve Tape is an implantable device composed of decellularized porcine tissue embedded with microhooks that attach to damaged nerves and may heal them more quickly and safely than conventional sutures.
Australia’s Therapeutics Goods Administration (TGA) cleared Orthocell Ltd.’s regenerative nerve repair device, Remplir, a biological scaffold that mimics the outer layer of the peripheral nerve to facilitate nerve repair.
