Harith Rajagopalan, MD, PhD, and Jay Caplan established Fractyl Health, initially named Fractyl Laboratories,[5] in 2010.[6] The company's Revita device gained CE marking in April 2016[7] and became commercially available in the UK in January 2020.[8] In April 2021, the US Food and Drug Administration (FDA) gave Revita breakthrough device designation to treat type 2 diabetes.[9] The company changed its name to Fractyl Health in June 2021.[10]
In April 2022, the FDA approved an investigational device exemption trial for Revita.[11] It became available commercially in Germany in early 2023.[12] The FDA issued additional breakthrough device designation to Revita in July 2024 for weight maintenance in certain people with type 2 diabetes or obesity.[13][14]
Fractyl had an initial public offering on the Nasdaq in February 2024.[15]As of February2025[update],[16] the company's REMAIN-1 study is evaluating Revita for patients with obesity to support weight maintenance after use of a GLP-1 drug.[17] In January 2025, Fractyl announced it would focus research for Revita on obesity and people on GLP-1s,[18] citing rising demand driven by the popularity of GLP-1s.[19] The company also laid off some employees focused on type 2 diabetes treatment.[20]
Products
Fractyl's therapies focus on the root causes of metabolic diseases like obesity.[4]
Revita
Revita is an outpatient endoscopic procedure that resurfaces the mucosal lining of the duodenum using ablation with water and heat.[13][21] The duodenal lining can thicken with chronic high-fat and high-sugar diets;[22] this can damage signaling mechanisms in the gastrointestinal tract[13] and lead to metabolic disease.[23][24] After resurfacing, a healthy mucosal layer can regrow over time, potentially improving blood sugar regulation[5] and insulin sensitivity.[22]
Rejuva
Rejuva is an adeno-associated virus (AAV)-based gene therapy platform to enable the pancreas to produce GLP-1 on an ongoing basis as a treatment for obesity and type 2 diabetes.[25] The therapy targets dysfunctional betaislet cells in the pancreas.[26] Delivery is done with a needle catheter to deliver viral vectors into the pancreas.[26]
In January 2025, Rejuva completed Clinical Trial Application-enabling preclinical in vivo studies,[27] beginning its first-in-human studies in the first half of 2025.[28]
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