Fractyl Health this week announced encouraging interim feasibility data from its diabetes reversal technology study. Lexington, Massachusetts–based Fractyl’s Revita-T2Di long-term open-label cohort assessed eight patients followed through at least four weeks having been treated. The company’s Revita system resurfaces the upper intestine lining (duodenal mucosa) to treat metabolic disease in patients with insulin-treated type 2 […]
Clinical Trials
FDA grants IDE approval for Capillary Biomedical’s 7-day-wear infusion set
Capillary Biomedical announced today that it received FDA investigational device exemption (IDE) for its SteadiFlow infusion technology. Irvine, California-based Capillary Biomedical designed its new SteadiFlow seven-day-wear infusion set technology to significantly extend patient wear time to a week and maintain insulin stability. The SteadiSet infusion set, powered by the SteadiFlow technology platform, features an integrated […]
PharmaJet partner announces COVID-19 vaccine trial with needle-free injection tech
PharmaJet announced today that one of its pharmaceutical partners, Nykode Therapeutics, has begun a trial for a COVID-19 vaccine with PharmaJet’s needle-free injection technology. Nykode’s Phase 1/2 clinical trial will specifically address the emerging SARS-CoV-2 variants, with the DNA-based vaccines delivered intramuscularly with PharmaJet’s Stratis needle-free injection system. The vaccines are designed to be tailored […]
Virpax reports positive non-human study results for topical spray film that treats chronic pain
Virpax Pharmaceuticals (NSDQ:VRPX) today reported positive results from a study of its Epoladerm treatment for chronic pain management. Berwyn, Pennsylvania-based Virpax designed Epoladerm, one of its lead investigational products, for managing pain associated with osteoarthritis of the knee. According to a news release, the company reported positive results following the completion of a toxicology and […]
Baxter touts data supporting use of machine learning for infusion pump programming
Baxter (NYSE:BAX) announced today that data shows the potential for machine learning supporting decision-making with infusion pump programming. Deerfield, Illinois-based Baxter presented the data from a retrospective study — part of a collaboration with MedAware aimed to develop next-generation dose error reduction software — at the American Society of Health-System Pharmacists (ASHP) 2021 Midyear Clinical […]
Inhaled drug delivery tech company Aerami to go public through SPAC merger
Aerami Therapeutics announced today that it entered into a merger agreement with FoxWayne Enterprises Acquisition Corp. (NSDQ:FOXWU). Through the definitive business combination agreement with the special purpose acquisition company (SPAC), Aerami, a developer of inhaled therapies for treating respiratory and chronic diseases, will be listed on the Nasdaq market as “Aerami Therapeutics Holdings, Inc.” According […]
Ocular Therapeutix touts positive trial results of ophthalmic insert for dry eye disease
Ocular Therapeutix (NSDQ:OCUL) announced today that it reported positive results from a Phase 2 trial of its dry eye disease treatment. Bedford, Massachusetts-based Ocular Therapeutix’s U.S.-based Phase 2 clinical trial evaluated OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of dry eye disease. The randomized, double-masked, vehicle-controlled, multi-center trial evaluated two different formulations of […]
Visus Therapeutics touts data from trial of presbyopia treatment
Visus Therapeutics announced today that three novel presbyopia treatments achieved their improvement endpoints in a Phase 2 study. Seattle-based Visus’ Vivid Phase 2 study observed all three of the included investigational candidates achieve the endpoint of three lines of improvement in binocular near visual activity without losing one line of distance vision with a minimum […]
FDA authorizes expansion of Fractyl’s pivotal clinical trial for diabetes reversal tech
Fractyl Health announced today that the FDA gave authorization to expand the Revitalize-1 pivotal clinical study of its Revita DMR system. Lexington, Massachusetts-based Fractyl Health (formerly Fractyl Laboratories) can now increase the sample size of the Revitalize-1 trial (formerly Revita-T2Di trial) from 288 to 420. In September, Fractyl activated the 10th clinical site in the […]
Medtronic plans to bring next-gen diabetes tech to FDA this fiscal year, no spinoff planned
Medtronic (NYSE:MDT) confirmed that it anticipates major regulatory steps for its next-generation insulin pump and sensor during this fiscal year. Medtronic’s fiscal years wrap up at the end of April. Speaking on the company’s second-quarter earnings call, Chair & CEO Geoff Martha said Medtronic expects its MiniMed 780G insulin pump system with the Guardian 4 […]
