Medtronic (NYSE:MDT) yesterday disputed a newspaper’s report about an internal review of some 3,647 patients implanted with its controversial Infuse bone-growth protein, saying the piece made false insinuations and omitted key facts. The Minneapolis Star Tribune reported yesterday that Medtronic employees spent 2 years reviewing the records but failed to report the 1,000 adverse events to the FDA– […]
Regenerative Medicine
Amniox Med touts reimbursement win
Amniox Medical said yesterday it won reimbursement for its Neox wound matrix umbilical cord allograft through Wisconsin Physicians Service Insurance corp, who will provide Medicare coverage for the treatment for chronic, non-healing wounds. The WPS Insurance group administers Part A and Part B Medicare benefits for Iowa, Kansas, Missouri, Nebraska, Indiana and Michigan for 4.4 million individuals, […]
Harvard Apparatus rebrands as Biostage
Harvard Apparatus Regenerative Technology (NSDQ:HART) said today it is rebranding as Biostage, Inc. and shifting its Nasdaq symbol to “BSTG”, effective April 1. The company said the brand shift “reflects the company’s broad commitment and expertise in pioneering the development of bioengineered organ implants for the esophagus, bronchus and trachea.” “The Biostage name change reflects the evolution of […]
Former Advanced BioHealing exec Clawson pleads guilty in VA fraud case
Former Advanced BioHealing executive Todd Clawson last week pleaded guilty to federal charges that he bribed U.S. Veterans Affairs Dept. doctors to use the company’s DermaGraft biologic wound dressing. Federal prosecutors accused Clawson, who left the company in 2012, of participating in a scheme to bribe VA physicians to use the DermaGraft diabetic foot ulcer treatment with a […]
Xtant, Vivex ink distribution deal for OsteoVive allograft
Xtant Medical said today it inked a distribution deal with Vivex Biomedical to distribute its OsteoVive cellular bone allograft. The new agreement will allow Xtant to enter the cellular bone graft market which the company said is estimated to be between $252 million in 2015 and $400 million in 2019. “Vivex is enthusiastic about teaming up with […]
Baxter wins expanded EU indication for Hemopatch
Baxter (NYSE:BAX) said today it won CE Mark approval in the European Union for an expanded indication for its ready-to-use surgical Hemopatch. The Deerfield, Ill.-based company’s Hemopatch is now cleared for use in closing dural defects including excision, retraction or shrinkage of the dura mater following traumatic injury. The patch is also cleared as a hemostatic […]
Gore launches new type of study for Synecor hernia biomaterial
W.L. Gore & Associates said today it is launching a clinical quality improvement project to study its Synecor biomaterial designed for open, laparoscopic and robotic single-stage hernia repairs. The Synecor biomaterial is comprised of dense monofilament polytetrafluoroethylene macroporous knit to provide strength and reduce bacteria growth, Gore’s Bio-A Web tissue scaffold and a non-porous PGA/TMC […]
Sanuwave trial misses efficacy endpoint but shows superiority at 24 weeks
Sanuwave Health (OTC:SNWV) today released 24-week data from the pivotal trial of its dermaPace, saying it missed its 12-week primary efficacy endpoint but returned a greater reduction in wound size and lowered amounts of subjects with increased wound size compared to the control treatment at 24 weeks. Data came from 2 24-week studies at 39 centers across the […]
Amniox Medical touts foot ulcer study data
Amniox Medical today released results from a retrospective study of its Neox wound allograft in treating chronic diabetic foot ulcers touting an 87% rate of healing in patients treated with the allograft. Findings from the study were presented at Superbones Superwounds East 2016 in Teanack, N.J. last week. “These findings are quite positive for the […]
ACell wins 510(k) for modified MicroMatrix
ACell said today it won additional FDA 510(k) clearance for its MicroMatrix device allowing the use of the device in conjunction with Cytal wound matrix or Cytal burn matrix devices. The MicroMatrix is a micronized particulate form of ACell’s Urinary Bladder Matrix designed to cover the wound bed in normal or irregular wounds, the Columbia, […]
Osiris wins positive review from BCBSA for Grafix
Osiris Therapeutics said today the Blue Cross Blue Shield Association gave the company’s Grafix a positive review when used to treat individuals with diabetic lower-extremity ulcers. Gravix is a cryopreserved placental membrane designed as a wound cover for patients with chronic wounds, and can conform and be applied directly to acute and chronic wounds, the company […]