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.
Toosonix A/S has launched two trials as it moves to gather data enabling its high-intensity focused ultrasound (HIFU) device to get approval for use in clinical dermatology indications. The company reported on April 19 that the first patients have been treated in a trial of its System One-M device in treating basal cell carcinoma (BCC). Meanwhile, the first patient has been cleared for treatment on April 28 in a study in neurofibromatosis, an inherited condition that causes benign tumors to form on the skin.
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.
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.
Privately held Leo Pharma Inc. has worked its way through a complete response letter issued in April to see the FDA approve Adbry (tralokinumab-ldrm) for treating moderate to severe atopic dermatitis in adults. The CRL noted FDA requests for additional data related to the device component, a prefilled syringe of tralokinumab, but it did not request new efficacy or safety data related to the drug product formulation. In April and on Dec. 28, the company did not provide details on the device-related data that were requested.
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