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Home » Topics » Dental, BioWorld MedTech

Dental, BioWorld MedTech
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Tetratherix Tetramatrix

Tetratherix lists on ASX in $25M IPO

June 30, 2025
By Tamra Sami
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.
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Dental X-ray

FDA takes a bite out of confusion with four new dental guidances

Sep. 30, 2024
By Mark McCarty
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.
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Science and medicine icons with head made of computer code

FDA to convene advisory meeting on generative AI-enabled devices

Sep. 16, 2024
By Mark McCarty
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.
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U.S. flag on columned building

Planmeca hit with PHOSITA blues in patent litigation with Osseo

Sep. 5, 2024
By Mark McCarty
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.
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Image from pilot animal study

​US FDA wary of predicate devices in draft guidance for jawbone grafts​

April 1, 2024
By Mark McCarty
The U.S. FDA issued a draft guidance for premarket applications for class II bone grafting devices, a policy that would supplement a guidance issued nearly two decades ago.
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Business people with hands atop a digital globe

Orthocell inks global deal with Biohorizons for dental collagen membrane worth $16M

July 5, 2022
By Tamra Sami
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.
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Dental X-ray

Wishbone raises $3M to ramp commercialization of its dental implant bone regeneration technology

Dec. 6, 2021
By Bernard Banga
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.
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Two arrows in opposite directions

Zimmer Biomet streamlines focus with spinoff of spine and dental businesses

Feb. 8, 2021
By Meg Bryant
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.
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Orthocell CEO with employees in the lab

Orthocell’s stock soars following FDA 510(k) clearance of regenerative collagen medical device

Jan. 14, 2021
By Tamra Sami
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.
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Image from pilot animal study

Launchpad Medical nabs $1.8M grant for pivotal animal study of dental bone graft solution

June 2, 2020
By Meg Bryant
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.
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