Fractyl Health is developing Revita DMR, an outpatient endoscopic procedure that resurfaces the duodenal mucosa to treat insulin resistance and metabolic disease. Revita DMR has been studied in close to 300 patients and has received FDA Breakthrough Device Designation for T2D patients treated with insulin, as well as a CE mark in the EU. In the U.S. the device is not yet authorized for marketing and is being evaluated under an FDA-approved Investigational Device Exemption study. The company says its discoveries could address other metabolic diseases such as NAFLD/NASH and aim to reduce the global healthcare and economic burden of metabolic disease. Proceeds from the recent financing will support initiation of multiple late-stage clinical studies and accelerate ongoing REVITA-T2Di work to establish Revita DMR as a cornerstone therapy and reduce insulin dependence. Fractyl is based in Lexington, Mass., and recently renamed itself Fractyl Health to reflect its broader mission. Fractyl Laboratories is developing Revita DMR, a same-day, outpatient endoscopic procedure that uses heat to resurface the duodenal mucosa to reset metabolic pathways and address insulin resistance. Clinical data from close to 300 patients at more than 20 centers across three continents have shown durable improvements in type 2 diabetes and fatty liver disease and a favorable safety profile with no long-term adverse events reported. The Revita DMR System received a CE mark in April 2016 and the CE label was expanded in March 2020 to include insulin withdrawal, improvements in NAFLD/NASH in patients with T2D, and improved insulin sensitivity in PCOS. In the United States, Revita is approved for investigational use only by the FDA. Fractyl announced a first close of $55 million in a Series E financing; proceeds will support the Revita T2Di pivotal clinical trial examining glycemic control and insulin requirements, with a primary endpoint of percentage of patients achieving HbA1c ≤7% without insulin at 24 weeks versus sham. The company plans to initiate its pivotal U.S. trial later this year and use the financing to advance its regulatory and development activities for metabolic disease indications. Fractyl Labs develops Revita Duodenal Mucosal Resurfacing (DMR), an outpatient procedure intended to rejuvenate the duodenum and improve insulin sensitivity in people with type 2 diabetes. The company reports that a one-time Revita DMR treatment yields insulin-sensitizing effects and durable improvements in hepatic and glycemic indices over a year without intensive lifestyle changes. Fractyl plans to use the new funding to continue development of its Revita DMR technology and to support an ongoing Revita-2 multi-center clinical study, which began enrolling patients in Europe in May. Last year the Revita DMR System received a CE mark in the European Union. The company aims to submit an investigational device application with the U.S. Food and Drug Administration to enable investigational use in the United States. Fractyl recently raised $44 million in a Series D financing from multiple venture firms to advance these efforts. Fractyl Laboratories develops the Revita Duodenal Mucosal Resurfacing (DMR) system, a same-day, minimally invasive procedure intended to improve metabolic health in patients with type 2 diabetes. The approach is based on bariatric surgery procedures and aims to produce meaningful improvements in blood sugar and potentially reduce the need for additional medications. The company reported results from a 39-patient, single-site proof-of-concept study showing significant, beneficial changes in blood sugar and has treated 28 patients in its first international multicenter clinical trial. A multicenter Revita-1 trial is currently underway in Europe and South America, and Fractyl plans to begin randomized studies next year. Fractyl recently completed a $57M Series C extension to support and accelerate its clinical development and path to market. The company is headquartered in Waltham, MA, and its Revita system remains for investigational use only while trials continue. Fractyl Labs is developing Revita DMR, a non-invasive duodenal mucosal resurfacing procedure intended to alter the inner surface of the duodenum to change how the body absorbs sugar. The company says the procedure can potentially delay the need for insulin injections in patients with type 2 diabetes. Fractyl reported positive clinical data from a single-site study in Santiago, Chile showing a greater than two percentage-point drop in hemoglobin A1C at three months in 19 of 30 patients, with those 19 maintaining the same blood sugar level at six months. The effectiveness appeared dose-dependent: shorter treated segments produced smaller benefits. Fractyl is preparing to launch a multinational study by the end of 2014 and expects to start U.S. clinical development in 2016. The company is based in Waltham, Massachusetts, and is led by CEO and founder Dr. Harith Rajagopalan.

Total raised

$256M

Funding rounds

5

Latest round

Series F

Latest activity

Jun 2021