Stimlabs LLC has taken a new view of wound healing by developing a fenestrated dehydrated complete human placental membrane allograft for chronic and acute wounds. The fenestration in the Release product allows fluids to drain away from the wound, promoting faster healing, while the tissue provides protection.
Fractyl Health Inc. reported clinical updates on the Revita real world registry in Germany which has demonstrated clinical remission from type 2 diabetes (T2D) employing a device that resurfaces the duodenal mucosa, the innermost layer of the first portion of the small intestine, and a potential root cause of T2D.
Two companies presented highlights of studies that demonstrated outstanding results for novel devices at last weekend’s American Diabetes Association’s (ADA) 83rd Scientific Sessions, while Embecta Corp. and Senseonics Holdings Inc. provided updates that position them well for long-term performance. Glyconics Ltd. revealed a fingernail scanning device that simplifies screening for diabetes and Fractyl Health Inc. showed that its Revita procedure reduced blood glucose levels and promoted weight loss.
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.
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.
Improving metabolic disorders without major changes in diet and exercise is typically seen as impossible, unless bariatric surgery is involved. But that’s precisely what Fractyl Laboratories Inc. aims to do. It plans to start a pivotal trial of its duodenal mucosal resurfacing system, Revita DMR, before year end.
Fractyl Laboratories Inc. has released data from a mixed meal tolerance study that shows its procedure for resurfacing the duodenal mucosa improves fasting blood glucose and reduces liver fat.