Ocular Therapeutix (NSDQ:OCUL) said today that it received a warning letter from the FDA over its ReSure hydrogel ocular wound sealant. The warning letter, dated Oct. 17, relates to Ocular’s compliance with data collection and reporting obligations in a post-approval device exposure registry study, according to the company. The registry study was a condition for approval […]
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 […]
Smith & Nephew launches portable negative pressure wound therapy system
Smith & Nephew announced today that it has launched its Pico 7Y single-use negative pressure wound therapy system (sNPWT) in Europe. The system features AirLock technology and includes an integrated Y extension that allows for two dressings to be used from one pump to allow for two wounds to be treated at the same […]
ConvaTec CEO steps down amid lowered outlook
ConvaTec (LON:CTEC) shares lost a third of their value today after the British wound care giant said the CEO that took it public two years ago is stepping down and lowered its outlook for the rest of the year. Chief executive Paul Moraviec, who led ConvaTec to a $1.8 billion initial public offering in October 2016, […]
Report: MiMedx held lower-cost grafts from federal hospitals
MiMedx (NSDQ:MDXG), already embroiled in an internal accounting snafu and several federal probes, reportedly held from government hospitals some of the lower-cost products it made available to private hospitals. In limiting its regenerative wound care offering to U.S. Veteran Affairs Dept. and other federal caregivers, Marietta, Ga.-based MiMedx ran up the tab on taxpayers, the Wall […]
Covalon Technologies closes $12m AquaGuard buy
Covalon Technologies said yesterday it closed its $12.4 million (CAD $16.1 million) acquisition of Cenorin’s AquaGuard division. Cenorin’s AquaGuard develops products intended to provide patients with moisture protection for wound, surgical and vascular access sites during showers, Ontario-based Covalon said. Covalon said that during its last fiscal year, the AquaGuard business recorded sales of $8.5 […]
Ex-MiMedx brass blast back
Some of the former top brass at MiMedx (NSDQ:MDXG), who were let go over the summer for what the company later determined to be “for cause,” said that their ousters were part of an out-of-control internal investigation. Last week MiMedx, which makes regenerative and therapeutic biologics using human placental tissue allografts, said a probe into its accounting practices […]
Judge slaps lawyers with $1.4m in fines over $645m KCI trade theft case
A federal judge this week slapped lawyers representing Healthcare Essentials in a trade theft lawsuit brought by Acelity subsidiary Kinetic Concepts Inc. with some $1.4 million in fines for their part in the case. Earlier this month KCI was awarded $645 million in damages after winning the suit. KCI accused Healthcare Essentials of stealing its VAC negative pressure wound […]
Covalon to acquire Cenorin’s AquaGuard for $12m
Covalon Technologies said today it inked a definitive agreement to acquire Cenorin’s AquaGuard division in a deal worth approximately $12.4 million (CAD $16.1 million). AquaGuard develops products intended to provide patients with moisture protection for wound, surgical and vascular access sites during showers, Ontario-based Covalon said. Current AquaGuard CEO Gerry Arambula and existing leadership at the […]
Wound Management Tech spins CellerateRX collagen asset into JV with Catalyst Group
Wound Management Technologies (OTC:WNDM), operating under WNDM Medical, said last week it inked a deal to spin out its CellerateRX activated collagen assets into a new joint venture with The Catalyst Group. Fort Worth, Texas-based Wound Management Tech will maintain a 50% ownership interest in the new joint venture, with The Catalyst Group taking up the […]
Avita begins Recell manufacturing in new facility
Avita Medical (ASX:AVH) said today that it successfully finished multiple production runs for its Recell device at its newly-acquired manufacturing facility in Ventura, California. Avita acquired the facility last month from a manufacturer that previously assembled the Recell device on a contract basis. The components being made at the Ventura facility will be used to support the […]
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