Organogenesis yesterday it is releasing results from a comparative effectiveness analysis of its Apligraf and Dermagraf artificial skin grafts showing superior performance compared to its competitors, and released data from a previous study of its graft being used to treat diabetic foot ulcers. The results will be reported at the Symposium on Advanced Wound Care’s […]
Regenerative Medicine
Innovative Biotherapies wins $1.6m rare disease grant from FDA
Bioartificial organ-based device developer Innovative Biotherapies won $1.6 million from the FDA through a grant to boost the development of products for patients with rare diseases, according to the federal watchdog. The $1.6 million, distributed over 4 years, will aid Innovative Biotherapies in a Phase 2 study of selective cytopheretic device for the treatment of […]
Histogenics inks supply deal with Collagen Solutions
Regenerative medicine-focused Histogenics said Wednesday it signed a supply deal with U.K.-based Collagen Solutions. Collagen Solutions will provide collagen material sources for use in Histogenics investigational NeoCart which is being designed to repair knee cartilage damage. The NeoCart product is currently in phase 3 trials. “Collagen Solutions has again demonstrated that it can provide materials […]
Ventrix launches cardiac scaffolding trial
Cardiac bio-scaffold company Ventrix said it launched a trial of its VentriGel biomaterial scaffold designed to repair cardiac tissue in patients who’ve suffered a myocardial infarction. The phase 1, open-label trial is slated to enroll patients who’ve experienced their 1st myocardial infarction in the past 3 years and show signs of left ventricular dysfunction, according to […]
Down-under medtech firm Admedus looks to future in bio-scaffolds
Australian med-tech company Admedus (ASX:AHZ) is looking to become the “gold standard” in cardiac bio-scaffolds and expand their product into other realms to promote rebuilding of tissue over artificial replacements. Admedus COO Julian Chick spoke to MassDevice.com yesterday about the company’s flagship product CardioCel, how its using bio-scaffolds to grow in the cardiac repair market and […]
MiroMatrix raises $23m for decellularizing tech
Decellularization technology developer MiroMatrix Medical raised $23 million in a new round of equity financing, according to an SEC filing posted last week. MiroMatrix develops and utilizes a proprietary technology to remove cells, or decellularize, organs and tissue. Currently, MiroMatrix has 510(k) clearance for its MiroMesh biological mesh used during hernia repair procedures and as a […]
NovaBone wins PMA for MacroForm bone repair device
Bio-active synthetic bone graft company NovaBone said today it won FDA premarket approval for its MacroForm minimally invasive bone repair device. The device is designed to deliver bone marrow aspirate to a graft via an minimally invasive cannula, the Jacksonville, Fla.-based company said. “The MacroForm MIS delivery system builds off the commercial success of the […]
Vital Therapies trial fails to meet endpoints
Vital Therapies (NSDQ:VTL) said today that the Phase III clinical trial of its Elad cell-based therapy treatment for liver failure did not meet primary or secondary endpoints and the company is shutting down 2 other clinical studies of the device. The randomized, controlled, 203-patient trial examined the efficacy of the cell-based therapy in treating subjects with alcohol-induced […]
Aurora Spine wins CE Mark for TiNano spine implant
Aurora Spine (TSX:ASG.V) said Tuesday it won CE Mark approval in the European Union for its TiNano spinal fusion implants. TiNano implants are sterile-packed titanium coated spinal implants made of PEEK thermoplastic material, the Carlsbad, Calif.-based company said. “This CE Mark issuance is a major accomplishment for Aurora Spine. TiNano intervertebral implants are developed to […]
Integra Lifesciences closes TEI acquisition
Integra LifeSciences (NSDQ:IART) said today it closed its acquisition of all outstanding shares of TEI Biosciences and TEI Medical. The purchase allows Integra to broaden its portfolio of reconstructive and regenerative wound care products, the Plainsboro, N.J.-based company said. “We are enthusiastic about the strategic fit of these 2 organizations, and the positive impact TEI has […]
Tengion successor RegenMedTX raises $4m
RegenMedTX, which acquired the assets of bankrupt organ regeneration technology company Tengion (NSDQ:TNGN) in March, said it raised more than $4 million from a syndicate of 27 unnamed investors. Winston-Salem, N.C.-based RegenMedTX is led by former Tengion CSO Tim Bertram and CTO Deepak Jain, the Winston-Salem Journal reported. Tengion, which pulled the plug in December 2014 after seeking but […]