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.
Authors of a multi-center study welcomed results from a device that works with a smartphone or tablet to capture medical images for a more detailed understanding of infected wounds. By capturing heat produced by a wound and using bacterial fluorescence, the Swift Ray 1 developed by Swift Medical Inc., may help clinicians tell the difference between inflammation and a potentially dangerous infection.
Stimlabs LLC has taken a new view of wound healing by developing a fenestrated dehydrated complete human placental membrane allograft for chronic and acute wounds. The fenestration in the Release product allows fluids to drain away from the wound, promoting faster healing, while the tissue provides protection.