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.
Prospects for Zerigo Health Inc. brightened with a series B fundraising round that brought in $43 million to support expansion of the company’s at-home ultraviolet B phototherapy system for chronic skin conditions. The connected system enables a physician to ensure the prescribed dose is delivered while freeing patients from the thrice-weekly office visits often required for treatment of psoriasis, vitiligo and eczema.
Castle Biosciences Inc. is acquiring gastrointestinal (GI) diagnostics company Cernostics Inc. in a transaction valued up to $80 million. The deal marks a move from Castle’s focus on dermatology diagnostics to include GI disorders and could expand its estimated U.S. total addressable market by approximately $1 billion, the company said. Shares of Castle Biosciences (NASDAQ:CSTL) jumped 7.8% to close at $67.58 on Tuesday Oct. 19.
Polarityte Inc.’s Skinte product met primary and secondary endpoints in a randomized clinical trial evaluating healing of diabetic foot ulcers. Skinte is a human cellular and tissue-based product made from a patient’s own skin. Results from the trial and data from the product’s use from 2017 to 2021 during a period of enforcement discretion by the FDA were used by the company in its filing earlier this week of an investigational new drug application for Skinte.
A not-unexpected complete response letter (CRL) for Nexobrid, being developed by Mediwound Ltd., delayed the therapy’s approval and knocked the company’s share values backward. Nexobrid, proteolytic enzymes enriched in bromelain for treating for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns, had a June 29 PDUFA date.
More than four months after its original PDUFA date of Feb. 2, 2021, Mallinckrodt plc’s Stratagraft gained FDA approval for use in deep partial-thickness thermal burns.