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.
PARIS – Aptargroup Inc. is negotiating to buy Voluntis SA in a move that would complement its existing digital solutions portfolio and expand services to address multiple conditions and chronic diseases. "By being part of Aptar, we will be able to pursue a common ambition aimed at providing a complete digital health platform combining connected devices and digital therapeutics," Pierre Leurent, CEO and co-founder of Voluntis, told BioWorld.
Fractyl Health Inc. closed $100 million in new financing Wednesday to expand and accelerate clinical development efforts to reduce dependence on insulin among type 2 diabetes patients. The startup, which changed its name from Fractyl Laboratories Inc., will use the financing to support additional late-stage clinical studies for determining the potential of its Revita DMR.
Data on the prevalence of diabetes in the U.S. show that non-Hispanic white people are least likely to suffer from the disease. Yet to date most genetic studies of the glycemic traits that are used to diagnose and monitor type 2 diabetes and cardiometabolic health have focused on individuals of European ancestry.
PARIS – Readily3d SA has been awarded just under $600k by the European Union to develop a living model of the pancreas using its Tomolite 3D bioprinting technique. The European program, Enlight, boasts a total budget of $4.4 million provided by the European Innovation Fund 2020.
Information Data Systems Inc., doing business as One Drop, has earned the CE mark for its blood glucose prediction analysis engine to accurately forecast glucose levels up to eight hours in advance. The artificial intelligence (AI)-powered tool is indicated for people living with prediabetes, type 2 diabetes, including those on oral medications and/or insulin regimens, and gestational diabetes.
Becton, Dickinson and Co. (BD) has decided to spin off its diabetes care business, after nearly a century growing a broad portfolio of insulin injection devices. The transaction, which will result in a publicly traded company, tentatively dubbed Newco, is expected to be completed in the first half of 2022.
The FDA has granted breakthrough device designation to Fractyl Laboratories Inc. for Revita DMR, a duodenal mucosal resurfacing treatment for patients with type 2 diabetes. The company recently launched the pivotal REVITA-T2Di clinical trial to evaluate the treatment in this population, in hopes it will offer a new option for people with the metabolic disease.
LONDON – Startup company Glucomodicum Oy is preparing to commercialize a new technique for the needle-free monitoring of blood glucose levels, applying the principles of magnetohydrodynamics to noninvasively extract interstitial fluid through the skin.
Location, location, location. Not only is that the mantra for real estate, it often is seen as an answer to diversifying clinical trials. But having a trial site in or near an underserved community is no guarantee of a diverse study population, as health care disparities can be a more pervasive issue than location. That was one of the lessons learned from the development of Celltrans Inc.’s donislecel at the University of Illinois-Chicago.