The U.S. FDA granted premarket approval to Avita Medical Inc.’s Recell system for a wide range of full-thickness skin defects, potentially quintupling the company’s market opportunity. Recell is a cell harvesting device that produces and delivers a regenerative cell suspension using a small sample of the patient’s own skin. The Spray-On Skin cells, previously approved for use in severe burns, stimulate healing and repigmentation. “This is a landmark approval representing an inflection point for Avita Medical,” said Avita CEO Jim Corbett. “The FDA approval now offers surgeons a best-in-class treatment option for a multitude of severe wounds within inpatient and outpatient settings.”

If Orlucent Inc. has its way atypical moles in adults will soon give up their secrets to clinicians on the lookout for skin cancer, this after the Los Gatos, Calif.-based company received a U.S. FDA breakthrough device designation for its non-invasive Orlucent skin fluorescence imaging system. The system is a hand-held point-of-care molecular-based imaging device that identifies “tissue remodeling activity” inside atypical moles that could be a precursor to early melanoma.

Unlike amphibians, mammals do not regenerate appendages. Except when they do. “If you amputate one of the branches off of the antler [of a reindeer], it will also regenerate,” Jeff Biernaskie told BioWorld. Even without amputation, the antlers of both male and female reindeer regenerate annually, including their skin. That regeneration is “the only large mammal model of true skin regeneration,” he said.

After working through a complete response letter (CRL) brought about by COVID-19 from the U.S. FDA in June 2021, Mediwound Ltd. has received the agency’s approval for Nexobrid (anacaulase-bcdb) to treat severe burns in adults.

Since its launch in the U.S. in April, Biolab Sciences Inc.’s Dermistat has facilitated the healing of 80 wounds using its unusual gel-graft formula. The product transforms a patient’s skin cells into a partial thickness skin graft in 48 hours and a full-thickness graft in five to seven days. The autologous graft material speeds recovery following surgery or burns and helps to resolve non-healing wounds.

The U.S. FDA has rejected Verrica Pharmaceuticals Inc.’s drug-device combination to treat the viral skin disease molluscum for a third time, losing more ground to a potential rival from Novan Inc., because of continued manufacturing issues. There are no FDA-approved treatments for molluscum contagiosum, which leads to skin-colored or pink lesions and affects around 6 million people in the U.S. annually.

Sidekick Health AB expanded its partnership with Pfizer Inc., adding an atopic dermatitis offering to its integrated digital therapeutics solution. The app will roll out first in the U.K., followed by Belgium, Norway, Netherlands, Sweden, France, Ireland and Japan this year.

China’s NMPA has given 10 of Sihuan Pharmaceutical Holdings Group Ltd.’s skin repair products medical device registration certificates. The products are developed by its medical aesthetics platform Beijing Meiyan Kongjian Biology Medicine Co. Ltd. The certification is for three scar repair products, four medical dressing and patch products, as well as three skin repair products.

Med-tech startups looking to enter the South Korean market might do so with the 2021 Global Inbound Membership Bridge to Korea, or B2K 2021 program, run by Shinhan Financial Group Co. Ltd.’s Shinhan Square Bridge Incheon. The organization fosters startups with business scale-up services, new market development, partnering and investment assistance. Six med-tech and digital health firms were selected in November 2021: Aevice Health Pte. Ltd., Fairphonic Pte. Ltd., NDR Medical Technology Pte. Ltd., Scanderm Pro LLC, Sqin and Vertliner Private Co.