Mediwound Ltd. reported that the Nexobrid expanded treatment access protocol achieved complete debridement in 94.9% of adults and all children treated and removed all eschar within 24 hours. The results put more power behind a partnership with Vericel Corp. that introduced Nexobrid, an enzymatic debridement agent for severe thermal burns, into the U.S. in the fourth quarter of 2023 and increases the likelihood of an indication expansion into pediatrics.
AI-focused medical diagnostics company Spectral AI Inc. is collaborating with burn wound therapy company Polynovo Ltd. to test limited deployment of Spectral’s Deepview system for predicting burn healing in Australia.
U.S. Medicare coverage of products for leg and foot ulcers has undergone a second review in less than a year thanks to pushback from stakeholders after the August 2023 issuance of proposed non-coverage policies for more than 100 cell and tissue-based products.
Vomaris Inc. introduced its U.S. FDA-cleared Powerheal bioelectric bandage for over-the-counter use following studies showing a shocking 99.99% reduction in bacteria present in wounds covered with the bandage even without the use of antibiotics. The bandage’s electrical energy also stimulates cell movement, cutting healing time in half, a study found.
The U.S. FDA proposed in November 2023 to up-classify many wound care products that are associated with antimicrobial resistance, a change that would require a large number of clinical trials and a large volume of new premarket applications for the agency.
Stimlabs LLC received U.S. FDA approval for Corplex P, a wound care product that uses placental tissue to facilitate wound healing. “Corplex P is the first particulate device derived from human umbilical cord extracellular matrix indicated for the management of acute and chronic wounds,” Stimlabs CEO John Daniel told BioWorld.
Advanced Medical Solutions Group plc (AMS) signed an agreement to buy Peters Surgical SAS for up to €141.4 million (US$154.6 million). The move by AMS for the tissue repair and skin closure manufacturer is part of its strategy to buy assets which will strengthen its product portfolio and broaden its global reach.
The first patenting from 4M Biotech Inc. describes a wound dressing with incorporated color-changing pH sensors that are continuously responsive to the pH of wounds or wound exudate.
The U.S. Centers for Medicare & Medicaid Services (CMS) has released the prospective payment rule for end-stage renal disease (ESRD) for calendar year 2024, and advocates had some luck prompting the agency to boost the base ESRD payment rate. However, Atlanta-based Pain Care Labs Inc. came up short in its transitional add-on payment application for the Buzzy Pro for relief of puncture wound site pain because, according to CMS, the device does not represent a substantial improvement over currently available remedies.
Geethanjali Radhakrishnan, founder and managing director of Chennai, India-based Adiuvo Diagnostics Pvt. Ltd. reported filing for patent protection for a digital assistant for wound triaging and treatment recommendations.
