The U.S. FDA issued a draft guidance for premarket applications for class II bone grafting devices, a policy that would supplement a guidance issued nearly two decades ago.
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.
PARIS – Wishbone SA closed a $3 million funding round, which should allow it to obtain the CE mark prior to launching its range of products in Europe based on bone regeneration technology for reconstructive dental surgery. “Thanks to this round, we are ramping scale and moving from R&D to the commercialization phase in Europe,” Daniel Bee, CEO of Wishbone, told BioWorld.
Zimmer Biomet Holdings Inc. continued its transformation, disclosing Friday that it will spin off its spine and dental businesses into a separate, publicly traded company. The move will enable the independent company, identified as Newco, to pursue strategies and growth in spine and dental solutions that have not been a major focus for Zimmer Biomet, while allowing the latter to focus on high-growth orthopedic segments.
PERTH, Australia – Perth-based regenerative medicine company Orthocell Ltd. saw its shares rise 27% on the heels of its first U.S. approval for its collagen medical device for dental guided bone and soft tissue regeneration applications. “It’s an important milestone for us, and one that came quicker than I was expecting it to come,” Orthocell CEO Paul Anderson told BioWorld. The company submitted its 510(k) application to the FDA in May, and he was expecting approval by the middle of 2021.
Lowell, Mass.-based startup Launchpad Medical LLC has picked up an additional $1.8 million grant from the Michigan-Pittsburgh-Wyss Regenerative Medicine Resource Center to advance the development of its bone graft solution. The company plans to use the funds to conduct a pivotal animal study of the injectable biomaterial, which will pave the way for a U.S. FDA-approved clinical trial.
Ortek Therapeutics Inc., of Roslyn Heights, N.Y., has officially launched its electronic early cavity detection system, the Ortek-ECD. The U.S. FDA-cleared device can detect dental lesions before they show up on X-rays, enabling less invasive treatment and preventing greater damage to the tooth structure. Ortek holds the exclusive license for the device which was developed at Stony Brook University School of Dental Medicine.
San Jose, Calif.-based Align Technology Inc. has won the FDA’s nod for its Itero Element 5D imaging system. The company said the Itero Element 5D is the first intraoral scanner with near-infrared imaging (NIRI) technology that visualizes the internal structure of the tooth in real time. The FDA cleared the device for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.