PolarityTE wants to eliminate skin grafts with its platform of regenerative technology. The Utah-based biotech is still new to the industry, but co-founders Denver Lough and Ned Swanson are betting that their company can take on the clinical standard of care for wound management. “No other product, whether it be a drug, a biologic device, […]
Following first profitable quarter, Vericel’s CEO looks to grow portfolio of autologous cell therapy products
In its latest financial results, Cambridge, Mass.-based Vericel (NSDQ:VCEL) saw sales climb 60% for its permanent skin-replacement product, Epicel, designed for patients with severe burns. Sales for its autologous cellular scaffold, Maci, were up 20% following its launch to the commercial market. Vericel’s growing product adoption helped to fuel the company’s first profitable quarter, according to […]
MiMedx wins FDA regenerative med status for AmnioFix
MiMedx (NSDQ:MDXG) won regenerative medicine advanced therapy status from the FDA for its injectable osteoarthritis drug, AmnioFix, the company announced this week. The U.S. regulatory watchdog told MiMedx that the company provided sufficient preliminary evidence that AmnioFix could address unmet needs for patients with osteoarthritis of the knee. “The FDA’s RMAT designation for AmnioFix Injectable is […]
Ex-Advanced BioHealing exec draws probation in VA fraud case
A former Advanced BioHealing executive who admitted to federal charges that he bribed U.S. Veterans Affairs Dept. doctors to use the company’s DermaGraft biologic wound dressing last week drew probation in the case. Federal had prosecutors accused Todd Clawson, who left the company in 2012, of participating in a scheme to bribe VA physicians to use the DermaGraft diabetic […]
BioCardia files 2nd FDA IDE bid for CardiAMP chronic myocardial ischemia, refractory angina study
BioCardia (NSDQ:BCDA) said today it filed for a second FDA investigational device exemption to launch a trial of its CardiAMP cell therapy for treating chronic myocardial ischemia and refractory angina as it seeks a second indication. The San Carlos, Calif.-based company’s CardiAMP therapy uses autologous cells to treat chronic myocardial ischemia, and is designed to stimulate […]
These lab-grown blood vessel replacements could benefit dialysis patients
University of Minnesota researchers have developed a blood vessel replacement made of biological materials in a lab. The lab-grown vessels have no living cells at implantation and could be used as a graft for kidney dialysis patients. The lab-engineered blood vessel replacement is the first nonsynthetic, decellularized graft that is repopulated with cells using the […]
Histogenics inks deal to develop Neocart for the Japanese market
Histogenics (NSDQ:HSGX) has inked a deal with Medinet to develop and commercialize its Neocart implant for the Japanese market. The Waltham, Mass.-based company’s Neocart implant is designed to repair knee cartilage damage. The product is made using a patient’s own cells, harvested from the surface of the patient’s femur. “This transformative collaboration for Histogenics is […]
Researchers reverse diabetes in mice by infusing them with blood stem cells
Researchers at Boston Children’s Hospital successfully reversed Type I diabetes in a mouse model using blood stem cells, according to a study published this week in Science Translational Medicine. The researchers used cells that were pre-treated to make more of a protein, PD-L1, which is deficient in mice and people with Type I diabetes. “There’s really […]
Orthocell wins CE Mark for CelGro device
Orthocell (ASX:OCC) said today that its CelGro collagen medical device won CE Mark approval for a range of dental bone and soft tissue regeneration procedures. The company said it’s in talks with the strategic commercial partners to distribute its product throughout Europe and other key regions. Orthocell is also reportedly holding discussions with key opinion leaders […]
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 […]
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