It’s a good thing we live in the times of modern medicine. Historically, medical devices have been scary and unorthodox – and sometimes amounted to downright quackery. Surprisingly, a lot of these devices were thought to be useful in their era, long before the U.S. FDA started preapproving devices (which wasn’t until the 1970s). You […]
Regenerative Medicine
Avita Medical aims for $13m to bring ReCell burn injury device to U.S.
Avita Medical (ASX:AVH) said today that it hopes to raise $13.2 million to fund its efforts to bring its ReCell autologous cell harvesting device for treatment of burn injuries to the U.S. The Australia-based company said it received commitments from investors for a $3.5 million private placement. Avita added that it plans to undertake a rights […]
Smart bandage releases medication as needed
A team of researchers from the University of Nebraska, Harvard Medical School and MIT have created a smart bandage that can be loaded with antibiotics, painkillers or other drugs and triggered by a smartphone. The bandage, made of electrically conductive fibers individually coated in a drug-loaded hydrogel, could be used to deliver multiple drugs at a precise time and dose, […]
Xtant Medical to shut down Dayton, Ohio facility
Xtant Medical (NYSE:XTNT) said today that it plans to close its Dayton, Ohio facility and transition its operations to the company’s headquarters in Belgrade, Montana. The Dayton facility employs 55 people in an array of quality assurance, regulatory, inventory management, finance, engineering and distribution jobs, the company said, adding that many of these functions will transition […]
MiMedx closes Stability Biologics sale
MiMedx (NSDQ:MDXG) said this week that it completed the divestiture of its subsidiary, Stability Biologics, back to the former stockholders of Stability, Inc. The deal, which closed on Sept. 30, included a promissory note issued by Stability Biologics for $3.5 million in favor of MiMedx. Get the full story at our sister site, Drug Delivery Business […]
FDA expands protocol for investigational ReCell burn injury device
Avita Medical (ASX:AVH) said today that the FDA approved a supplement to the company’s investigational device exemption for its ReCell autologous cell harvesting device. The approved treatment protocol for burn injuries has been simplified, according to the company, and the number of approved investigational sites has grown from eight to 15. Get the full story at […]
Humacyte lands $14m to expand uses for human acellular vessel
Humacyte said today that it landed a $14.1 million award from the California Institute for Regenerative Medicine to support a clinical trial comparing its human acellular vessel, Humacyl, to arteriovenous fistulas – the traditional way to create vascular access in patients who need hemodialysis. The Research Triangle Park, N.C.-based company said it plans to evaluate […]
Avita Medical submits PMA app for ReCell burn injury treatment
Avita Medical (ASX:AVH) said today that it submitted its pre-market approval application to the FDA for its ReCell autologous cell harvesting device. The company’s system is designed to reduce the amount of skin harvesting needed to treat burn injuries compared to conventional treatments. Get the full story at our sister site, Drug Delivery Business News.
US Dept of HHS pulls the trigger on $24m contract option with Avita Medical
Avita Medical (ASX:AVH) said today it is executing a $24.3 million expanded contract option with the US Department of Health and Human Services to support development and procurement of its ReCell devices. The option is related to an original contract between Avita Medical and the Biomedical Advanced Research and Development Authority division of the HHS, and […]
CollPlant raises $5m in private placement
Regenerative medicine company CollPlant said today it inked a $5 million private placement deal to support its plant-based rhCollagen technology for tissue repairs. As part of the private placement round, Israel-based CollPlant said it will pursue an up-listing of its ADSs on the Nasdaq exchange following the 1st phase of the transaction closing, which is slated […]
3D-printed organ dev BioLife4D registers for $50m IPO
Biological 3D printing developer BioLife4D has filed for a $50 million initial public offering as it looks to commercialize its cardiac tissue regeneration and organ replacement processes. The Chicago-based company said yesterday it is developing technologies with an end goal of creating a 3D bioprinted viable human heart suitable for transplant. Funds from the offering […]