Mallinckrodt‘s (NYSE: MNK) Stratatech today received FDA approval for its StrataGraft for treating adult patients with thermal burns. The Bedminister, N.J.-based company designed StrataGraft to treat thermal burns that have intact dermal elements, or remaining deep skin layers, for which surgical intervention is clinically indicated. “Serious burns can be an incredibly difficult injury to treat and can […]
Stratatech Corp.
BARDA adds $26m to Stratatech’s StrataGraft development deal
Mallinckrodt‘s (NYSE: MNK) Stratatech has won an additional $26 million in Project BioShield funding from the the U.S. Biomedical Advanced Research and Development Authority to support pediatric studies of its StrataGraft engineered skin tissue. The funding will support continued development of the StrataGraft as a potential medical countermeasure for large-scale burn incidents, U.K.-based Mallinckrodt said. BARDA previously supplied […]
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 […]
Stratatech scores BARDA deal worth up to $247m
Stratatech said it won a contract from the Biomedical Advanced Research and Development Authority worth up to $247 million to develop its StrataGraft skin tissue designed for patients with severe thermal burns. The 5-year structured BARDA contract grants an initial $60 million for the “base period” and to procure the eventual-finished StrataGraft product to establish an inventory […]
J&J shareholders make noise | MassDevice.com On Call
MASSDEVICE ON CALL — Shareholders at Johnson & Johnson‘s (NYSE:JNJ) annual meeting had much to say about the company’s recent slew of high-profile product quality issues.
Diabetes: Stratatech lands $4.6 million to study antimicrobial skin graft for diabetic foot ulcers | Funding Roundup
Stratatech’s ExpressGraft
Stratatech Corp. won a $4.6 million grant to run a clinical trial from the National Institute of Diabetes & Digestive & Kidney Diseases.
The funds will support the first human study of Stratatech’s ExpressGraft Antimicrobial genetically engineered living skin substitute as a therapy for diabetic foot ulcers.
Stratatech lands $4.6 million to study antimicrobial skin graft
Stratatech Awarded $4.6-Million Clinical Trial Grant for ExpressGraft™ Antimicrobial Skin Substitute
MADISON, Wis.–(BUSINESS WIRE)–Stratatech Corp., a leader in regenerative medicine, today announced that the company has been awarded a $4.6-million grant by the National Institute of Diabetes and Digestive and Kidney Diseases to support the first human clinical trial of Stratatech’s ExpressGraft™ antimicrobial skin substitute. The clinical trial will assess the safety and efficacy of the tissue as a treatment for chronic diabetic foot ulcers. This pioneering product is the first therapeutic skin substitute to be genetically enhanced to fight infection and accelerate wound healing.
Calgary Scientific’s iPhone app receives FDA clearance | Regulatory Roundup
Calgary Scientific’s ResolutionMD mobile got a green light from the FDA for viewing diagnostic images on iPhones and iPads.
The ResolutionMD mobile app was built from existing ResolutionMD software, which recieved FDA clearance in 2006. The app already has the greenlight from Canada’s regulatory body, Health Canada and has a CE Mark for distribution in Europe.
Stratatech Initiates Second Clinical Trial of StrataGraft Skin Substitute
Stratatech Initiates Second Clinical Trial of StrataGraft® Skin Substitute
MADISON, Wis.–(BUSINESS WIRE)–Stratatech Corp., a leader in regenerative medicine, today announced that it has initiated its second multicenter clinical trial of the company’s StrataGraft® skin substitute. The clinical trial will assess the safety and clinical utility of the StrataGraft® skin substitute in the long-term treatment of patients with severe second-degree burns.
“We achieved our primary endpoints during StrataGraft’s Phase I clinical trial, which were related to safety and efficacy, and obtained important insights into the immunological response of patients with severe third-degree burns”
Stratatech wins $4 million in defense funding for living skin substitute
Stratatech Corp. won $3.95 million from the U.S. Dept. of Defense’s Armed Forces Institute of Regenerative Medicine.
The Madison, Wis.-based company said the AFIRM cash will fund the Phase IIb clinical trial of its StrataGraft cell-based, tissue-engineered skin substitute.
Stratatech plans clinical trial for skin substitute
Fresh off a $3 million funding round, Stratatech Corp. plans to begin Phase IIb clinical trials of its genetically engineered human skin substitute.
