Tetratherix Ltd. raised AU$45 million (US$25 million) in its IPO on the Australian Securities Exchange (ASX:TTX) to support clinical development of its Tetramatrix polymer biomaterial platform to support bone regeneration, tissue spacing and tissue healing.

The U.S. FDA has guidances on the books for dental products, but the it unleashed a quartet of guidances – ceramics and cements used in dental procedure – for dental products on the final Friday of September 2024. The agency also issued a guidance without comment – unusual for the FDA – for the well-known, terror-striking pneumatic dental hand tool.

The Nov. 20-21 meeting of the digital health advisory committee will discuss the use of generative artificial intelligence algorithms in medical devices with a focus on the total product life cycle – a theme that suggests a concern on the agency’s part regarding the reliability of these algorithms’ output.

The U.S. Court of Appeals for the Federal Circuit shot down Planmeca’s argument that expert testimony provided by Osseo was disqualified because the expert was not a PHOSITA at the time the patented articles were developed, leaving Planmeca with a negative verdict in excess of $2 million.

The U.S. FDA issued a draft guidance for premarket applications for class II bone grafting devices, a policy that would supplement a guidance issued nearly two decades ago.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.