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Fractyl Health, Inc. (GUTS)

Health Care · Medical device and gene therapy development (clinical-stage) · Nasdaq

Fractyl Health is a clinical-stage medical device and gene therapy company developing the Revita mucosa resurfacing procedure and Rejuva gene therapy platform for type 2 diabetes and metabolic disorders.

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What Fractyl Health, Inc. does

Fractyl Health is a pre-commercial, clinical-stage biopharmaceutical and medical device company developing innovative treatments for type 2 diabetes and metabolic diseases. The company's lead product candidate, Revita, is a minimally invasive endoscopic device that performs duodenal mucosa resurfacing (DMR) to improve glycemic control. Additionally, Fractyl is developing the Rejuva gene therapy platform, including the RJVA-001 candidate, which is expected to be regulated as a combination product. The company has not yet completed pivotal clinical studies and has no FDA-approved products on the market.

Themes: ["Type 2 diabetes / metabolic disease","Gene therapy","Medical devices","Endoscopic / minimally invasive procedures","Clinical-stage development"]

Fundamentals

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Key risks (from latest filing)

["Limited operating history with no approved products and no completed pivotal clinical studies; company has incurred substantial net losses since inception and raised substantial doubt about ability to continue as a going concern.","Heavy dependence on lead candidates Revita and RJVA-001; if unable to obtain regulatory approval or commercialize these products in a timely manner, business will be significantly harmed.","Lengthy and unpredictable FDA and foreign regulatory approval processes for medical devices and gene therapy combination products; clinical studies are expensive, time-consuming, and have uncertain outcomes."]

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Fundamentals: Finnhub, as of 2026-07-13. Filings: SEC EDGAR. Prices are delayed daily-close data.

Last updated 2026-07-10.

Informational only — NOT financial advice. All figures are delayed daily-close data from SEC EDGAR & Finnhub, shown with their as-of date.