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 […]
RenovaCare chairman ponies up nearly $16m for wound-healing stem cell SkinGun
RenovaCare (Scottsdale, Ariz.) has announced an equity financing for $15.5 million from Kalen Capital Corporation, the family office of Harmel Rayat, who is the majority shareholder and chairman of RenovaCare. The equity financing increases his family office’s total equity investment in RenovaCare to over $20 million. “Our long-term investment in RenovaCare speaks to our conviction that […]
Avita launches pediatric burn trial
Avita Medical (ASX:AVH) said today that it launched a new trial of its Recell autologous cell harvesting device exploring its use treating pediatric patients. The Recell autologous cell harvesting device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, the Valencia, Calif.-based company […]
U Penn trial regrows dental pulp from baby tooth stem cells
Data from recent clinical trial out of the University of Pennsylvania suggest that the use of stem cells from a patient’s baby teeth could be used to help regrow dental pulp tissue. Results from the trial, which was conducted in China, were published in the journal Science Translational Medicine. In the trial, 40 children were […]
These 10 medtech companies care a lot about research
These 10 medical device companies spent the largest portion of their budgets on research and development. Here’s a look at what they produced. Each year, Medical Design & Outsourcing compiles a list of the top 100 medical device companies across the globe and ranks the companies based on annual revenue for the most recent fiscal […]
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