Category Archives: COVID-19 Updates

PolarityTE on July 28 announced final data from a multi-center randomized controlled trial evaluating treatment of Diabetic Foot Ulcers (DFU) with its investigational product SkinTE®. The trial met the primary endpoint of wound closure at 12 weeks and secondary endpoint of Percent Area Reduction (PAR) assessed at 4, 6, 8, 10, and 12 weeks. Nikolai […]

PolarityTE recently announced that the China National Intellectual Property Administration (CNIPA) issued a Notification of Allowance for Chinese Patent Application No. 201580075326.3. The allowed claims relate to skin-regenerative compositions utilizing PolarityTE’s minimally polarized functional unit (MPFU) technology as well as methods of making a skin-regenerative composition utilizing the MPFU technology. This most recent allowance further […]

PolarityTE on Monday announced the submission of an investigational new drug application (IND) to the FDA seeking authorization to commence a clinical trial to evaluate its SkinTE product for the proposed indication of treatment of chronic cutaneous ulcers. SkinTE is PolarityTE’s human cellular and tissue-based product derived from a patient’s own skin. David Seaburg, Chief Executive […]

Last week, Foldax presented on the company’s innovative Tria valve at the 2021 Transcatheter Valve Technologies (TVT) meeting. View the slides HERE. The presentation titled “Foldax Biopolymer Valves: An Alternative to Tissue Based Leaflet Valves” was given by Foldax investigator, Dr. David Heimansohn, chief of surgery at St. Vincent/Ascension in Indiana and was well received. […]