Updated to include more information, commentary from Organogenesis. Medicare administrative contractor National Government Services has retired previous coverage policies on cellular and tissue-based products, effective September 1st. The change will allow new coverages and reimbursement through Medicare for such products based on FDA labeling and packaging. Derma Sciences (NSDQ:DSCI and Organogenesis have said the changes will allow for their products […]
Regenerative Medicine
Admedus touts Phase II follow-on data for CardioCel
Admedus (ASX:AHZ) yesterday released results from the Phase II extension study of its CardioCel regenerative used to repair congenital heart defects in pediatric patients, touting no signs of calcification or need for repeat procedures. Admedus’ CardioCel bio-scaffolds are regenerative tissue patches designed for cardiac and vascular repairs and reconstructions and promote autologous growth. “This is a significant […]
Opko Health gets in on BioCardia after merger with Tiger X Medical
BioCardia said today that Opko Health (NYSE:OPK) agreed to pick up a “significant” stake in its business after a merger with Tiger X Medical (OTC:CDOM). The new company will keep the BioCardia name and the development program for its CardiAMP cell therapy for heart failure patient’s who’ve had a heart attack. Stem cells derived from the bone marrow of […]
Northwestern Memorial joins InVivo Therapeutics neuro-spinal scaffold trial
InVivo Therapeutics (NSDQ:NVIV) said today that Chicago’s Northwestern Memorial Hospital is the 23rd site to join the clinical trial of its neuro-spinal scaffold. “Chicago, as with other major metropolitan areas, sees a disproportionally high number of acute, traumatic spinal cord injuries and unfortunately, with complete spinal cord injuries, trauma teams have limited tools at their disposal to […]
Another InVivo Therapeutics spinal scaffold implant patient improves
InVivo Therapeutics (NSDQ:NVIV) said today that the 9th spinal cord injury patient, implanted with its neuro-spinal scaffold last month, is already showing signs of improvement. InVivo’s neuro-spinal scaffold is surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting. The 9th patient in a clinical trial improved from a complete to incomplete […]
Rotation Medical adds $12m to Series B for regenerative rotator cuff treatment
Rotation Medical said today that it added $12 million to a Series B round that’s already brought in $27 million. Plymouth, Minn.-based Rotation makes a regenerative treatment for repairing the shoulder’s rotator cuff – a group of muscles and tendons that attach the humerus to the scapula. The system won 510(k) clearance in March 2014. The company said existing […]
Derma Sciences closes $80m deal for BioD
Derma Sciences (NSDQ:DSCI) said yesterday that it closed its acquisition of regenerative allograft maker BioD in a deal worth up to $78 million, including milestones and earn-outs. Princeton, N.J.-based Derma Sciences said it paid $21.3 million up front in a mix of cash and stock; meeting regulatory milestones could mean another $30 million, and the transaction included $26.5 million in earn-outs […]
Covidien spinout Mallinckrodt to acquire Stratatech
Mallinckrodt plc (NYSE: MNK) said today that it agreed to acquire Stratatech and its StrataGraft artificial skin graft technology for an undisclosed amount. Mallinckrodt, the pharmaceuticals business spun out of Covidien in 2013, said the deal also includes Stratatech’s development program for genetically enhanced skin. The acquisition is expected to close before the end of the year, the Dublin-based company […]
FDA plans advisory panel meeting on antimicrobial dressings
The FDA last week announced plans to hold an advisory panel meeting to cover the classification of wound care products containing antimicrobials and other drugs. The panel is slated to meet in Washington D.C. on September 20 and 21, according to a release from the federal watchdog. The FDA is seeking input on the indications […]
University of California pays $9m to settle Medtronic InFuse suits
The regents governing the University of California reportedly agreed to pony up $8.5 million to settle a pair of lawsuits brought against a former UCLA spine surgeon who used Medtronic‘s (NYSE:MDT) controversial InFuse bone-growth protein in their back surgeries. The lawsuits filed in the Los Angeles County Superior Court accused Dr. Jeffrey Wang of failing to disclose […]
Covalon wins $7.6m Saudi Arabian supply contract
Covalon Tech said today it won a $7.6 million 12-month supply contract with the Ministry of Health facilities in Saudi Arabia to supply the country with its ColActive Plus and ColActive Plus Ag wound care dressings. The Mississauga, Canada-based company said the contract was won after a “highly competitive bidding process” that selected Covalon as […]