Fractyl Health

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Fractyl Health, Inc.
FormerlyFractyl Laboratories
Company typePublic
Nasdaq: GUTS
Industry
Founded2010; 16 years ago (2010)
Founders
  • Jay Caplan
  • Harith Rajagopalan
Headquarters
Burlington, Massachusetts
Key people
Number of employees
88[2] (2024)
Websitefractyl.com

Fractyl Health is a Burlington, Massachusetts-based[3] healthcare company focused on metabolic diseases like obesity and type 2 diabetes.[4] The company developed Revita, an outpatient endoscopic procedure to modify duodenal dysfunction, and Rejuva, a gene therapy platform in preclinical development to enable the pancreas to produce glucagon-like peptide-1 (GLP-1).

History

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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 February 2025,[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

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Fractyl's therapies focus on the root causes of metabolic diseases like obesity.[4]

Revita

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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

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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 beta islet 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]

References

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