Admedus (ASX:AHZ) has won CE Mark approval in the European Union for its CardioCel 3D and VascuCel products which use its proprietary Adapt tissue technology, according to a report from ProactiveInvestors. The Australian company plans to begin the first stage of a commercial launch of the devices in the region later this month, according to the […]
Smith & Nephew puts up $660m for Osiris Therapeutics
Smith & Nephew (NYSE:SNN) said today that it agreed to put $660 million on the table to acquire Osiris Therapeutics (NSDQ:OSIR) and its regenerative medicine portfolio. The British orthopedics and wound care giant said the $19-per-share deal is a 37% premium on the 90-day volume-weighted average for OSIR shares. It’s structured as a two-step tender […]
Cellect Biotechnology launches U.S. clinical trial
Cellect Biotechnology (NSDQ:APOP) said it is collaborating with Washington University on a study of its ApoGraft stem cell selection technology for bone marrow transplantations. This will be the first clinical trial in the U.S. using Tel Aviv, Israel-based Cellect’s ApoGraft, which is designed to prevent acute graft-versus-host disease following bone marrow transplantation. The company previously reported positive safety and […]
Ortho RTi touts rotator cuff study results at conference
Startup Ortho Regenerative Technologies (CNSX:ORTH) said two new studies have validated its product’s ability to improve the repair of two distinct joint tissues – the rotator cuff tendon and articular cartilage. The rotator cuff study results were presented yesterday at the Annual Orthopaedic Research Society meeting in Austin, Texas. Get the full story on our sister site, Medical Design […]
Tela Bio, Aroa Biosurgery win FDA nod for large-size OviTex bioscaffolds
Tela Bio and its partner Aroa Biosurgery said yesterday that it won FDA 510(k) clearance for large-size OviTex reinforced bioscaffolds intended for soft tissue repair. The OviTex RBS devices are surgical implants with integrated biologic and synthetic materials to allow the movement of fluid and cells through the product, Malvern, Penn.-based Tela Bio said. With […]
PolarityTE registers bone repair product with FDA
PolarityTE (NSDQ:PTE) said last week that it registered its bone repair product, OsteoTE, with the FDA. The Utah-based company’s technology is an autologous, homologous product designed to repair, reconstruct and replace bone using a patient’s own cells. Get the full story at our sister site, Drug Delivery Business News.
Kuros raises $16m for bone-growth protein
Kuros Biosciences (SIX:KURN) said this week that it raised more than $16 million for clinical trial of its bone-growth protein as it expands the commercial footprint for its MagnetOs bone graft substitute. Proceeds from the CHF 16.1 million round are earmarked for a Phase II trial of the Fibrin-PTH protein in spinal fusion procedures and […]
MiMedx escapes Osiris trade theft suit
MiMedx (NSDQ:MDXG) enjoyed a rare spot of good news when a federal judge in Maryland this week dismissed a trade theft and breach-of-contract lawsuit brought by Osiris Therapeutics over MiMedx’s Stability Biologics acquisition. Columbia, Md.-based Osiris said it inked a distribution deal back in 2013 to have Stability sell a pair of its products through the end of 2015. But after […]
Shareholders approve Avista, Organogenesis tie up
Private equity firm Avista Healthcare Public Acquisition Corp. yesterday approved its merger with regenerative medicine company Organogenesis. The merger won approval yesterday at separate special meetings of shareholders for both companies, Canton, Mass.-based Organogenesis said. As part of the deal, Avista invested a total of $92 million in the combined company, Organogenesis said. Avista also […]
MiMedx accounting firm quits
The troubles at MiMedx (NSDQ:MDXG) continued last week with the resignation of the accounting firm tapped to audit its books in the wake of a financial scandal. Marietta, Ga.-based MiMedx last July ousted ex-CEO Parker Petit and president & COO William Taylor amid a board-directed independent investigation that had already prompted the departure of CFO Michael Senken and treasurer John […]
FDA warns Globus subsidiary HBT over ViaCell production facility issues
The FDA this week released a warning letter it sent to a Globus Medical (NYSE:GMED) subsidiary Human Biologics of Texas, which produces the company’s ViaCell allograft product, over issues it found during an inspection of the facility in April. The federal watchdog noted multiple infractions during the initial inspection, and also provided a response to corrective […]
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