Eluciderm Inc. has received clearance from the U.S. FDA for its IND to conduct a phase I/IIa open-label study evaluating the safety and efficacy of ELU-42, a topical spray-on solution for open wound healing, in patients with diabetic foot ulcers (DFUs).
Recce Pharmaceuticals Ltd. is progressing synthetic antibiotic Recce-327 to pivotal phase III trials in Indonesia for the treatment of diabetic foot infections. The trial, which is assessing Recce-327 as a topical gel (R327G), is expected to begin in the first quarter of 2025, Recce CEO James Graham told BioWorld.
Recce Pharmaceuticals Ltd. is progressing synthetic antibiotic Recce-327 to pivotal phase III trials in Indonesia for the treatment of diabetic foot infections. The trial, which is assessing Recce-327 as a topical gel (R327G), is expected to begin in the first quarter of 2025, Recce CEO James Graham told BioWorld.
Spectral MD Holdings Ltd. has delivered stark evidence of the need for its Deepview wound imaging system, in a study showing that medics in emergency rooms making initial judgments on the severity of burns were accurate only in 74% of cases. The critical feature is the depth of a burn.
After raising AU$2.2 million in its series A round, University of Western Australia spinout Lixa Pty Ltd. has emerged from stealth mode and is gearing up for clinical trials of its anti-biofilm platform technology that could preserve antibiotics in the fight against antimicrobial resistance.
Rokit Healthcare Inc. is working with Google Cloud to provide its personalized medical platform on the cloud computing services platform to improve treatment rates and medical access.
Investors kicked in $45 million in a series C financing round for Podimetrics Inc., the maker of a device that provides early indication of developing diabetic foot ulcers. D1 Capital Partners led the round with new investor Medtech Convergence Fund and an undisclosed strategic investor. Polaris Partners and Scientific Health Developed returned for the series C, which brought the total raised by Podimetrics to date to more than $73 million.
Rokit Healthcare Inc. received approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for Dfurege, its artificial organ platform to treat diabetic foot ulcers. “We hope that having a South Korean approval for this platform will be a boost for our planned IPO,” Seok Hwan You, CEO at Rokit, told BioWorld.
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.
