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.
Orthocell Ltd. landed its first global licensing deal for its regenerative collagen medical device with Biohorizons Inc., one of the largest dental implant companies in the world. The licensing deal comes on the heels of the Perth, Australia-based company reporting final data from its nerve reconstruction study that showed patients continued to improve between 12- and 24-months post-treatment with its regenerative nerve repair device Remplir.
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.
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.