As we celebrate more women becoming medtech leaders and paving the way for innovation, it’s important to remember the many accomplishments women have already made when it comes to the advancement of health and medicine. X-rays on the battlefield, the American Red Cross, leprosy treatment and more — these advances happened because of women. As […]
Regenerative Medicine
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. Get the full story at our sister site, […]
Medtronic wins one lawsuit, settles state AG probes over Infuse
Medtronic (NYSE:MDT) said a shareholder lawsuit brought over its Infuse bone-growth protein is over, after the U.S. Supreme Court declined to review the case. Approved in 2002 for use in spinal fusion surgery, Infuse at one point had annual sales of nearly $1 billion. The bone-grafting product has since been linked to abnormal bone growth, […]
Collagen Solutions jumps on positive study data
Shares in Collagen Solutions (LON:COS) rose this week after the U.K.-based company touted positive data from an eight-year study of 15 patients who received ChondroMimetic implants to repair cartilage defects in their knees. The company plans to apply for CE Mark clearance in the European Union for its ChrondroMimetic implant based on the results from […]
RenovaCare touts win in patent spat with Avita Medical
RenovaCare today touted a win in a patent spat with Avita Medical (ASX:AVH) after the US Patent Office dismissed a challenge to RenovaCare’s patents and denied a trial that Avita was seeking. RenovaCare said that the USPTO specifically noted that Avita’s arguments “were based on old claims and technologies which had already been considered and rejected,” […]
Avita wins expanded FDA compassionate use for ReCell device
Avita Medical (ASX:AVH) said today the FDA approved an expansion to the number of patients treatable by its ReCell device under the compassionate use investigational device exemption program by 20 individuals. 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 […]
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 […]
Anika collabs to develop injectable stem cell therapy for osteoarthritis
Anika Therapeutics (NSDQ:ANIK) has inked an agreement with the Institute of Integrative Biology at the University of Liverpool to develop an injectable mesenchymal stem cell therapy to treat osteoarthritis. As a result of the three-year research collaboration, the group hopes to have a lead candidate that it can take into clinical trials. Get the full story at our […]
Finland’s BBS-Bioactive Bone Substitute plans $10m IPO
BBS-Bioactive Bone Substitutes said today that’s its planning for an initial public offering later this year it hopes will bring in some $10 million. Oulu, Finland-based BBS said it plans to list 1.5 million shares at €5.50 apiece beginning Feb. 5 for gross proceeds of €7.7 million, or roughly $9.6 million. The shares, due to trade […]
Judge grants class certification in lawsuit over Medtronic’s Infuse
A federal judge in Minnesota yesterday granted class certification to an investors’ lawsuit brought against Medtronic (NYSE:MDT) over its Infuse bone-growth protein, a little more than a year after an appeals court revived the case. Approved in 2002 for use in spinal fusion surgery, Infuse at one point had annual sales of nearly $1 billion. The […]
Gecko Biomedical wins $7m French grant for tissue reconstruction tech
Gecko Biomedical said today that it won a French grant worth roughly $7 million has (€6 million) for the tissue reconstruction technology it’s developing. Paris-based Gecko said it plans to use the grant to commercialize its portfolio of synthetic light-activated polymers, which are designed to be biocompatible and bioresorbable and act as an adhesive, barrier or filler […]