Fractyl Health Inc (NASDAQ: GUTS) is a clinical-stage medical device company developing a duodenal mucosal resurfacing procedure called Revita DMR to treat type 2 diabetes (T2D). The company has no commercial revenue as of the 10-K filed 2026-03-24. Its income is limited to interest earned on cash, cash equivalents, and restricted cash balances. Fractyl completed its IPO in February 2024, at which point outstanding convertible promissory notes (the 2022 Convertible Notes) converted into common stock. The Revita DMR procedure has been evaluated across multiple clinical studies, including the completed Revita-2 randomized controlled trial (108 participants) and the INSPIRE pilot study (16 participants on long-acting insulin), with results showing reductions in HbA1c, liver fat (MRI-PDFF), HOMA-IR, and weight versus sham. The company is pre-commercial, spending on research, clinical development, and general and administrative functions as it pursues regulatory approval.

Revenue model

Fractyl Health generates no product revenue as of the 10-K filed 2026-03-24. Income is derived from interest on cash balances. The company is funded through equity capital raised at its February 2024 IPO and prior convertible note financing.

Products and services

Revita DMR (duodenal mucosal resurfacing): a catheter-based endoscopic procedure targeting the duodenal lining as a treatment for suboptimally controlled type 2 diabetes. Clinical studies include the U.S. Pilot (prematurely ended due to COVID-19), Revita-2 (108 participants, randomized double-blind sham-controlled), and INSPIRE (16 participants, open-label, investigator-initiated). The product candidate is not yet approved or commercially available.

Customers and end markets

Target end market is adults with suboptimally controlled type 2 diabetes, including patients on oral antidiabetic drugs, metformin, and long-acting insulin. Eventual customers would include hospitals, endoscopy centers, and physicians performing the procedure, with reimbursement dependent on payor coverage decisions from Medicare, Medicaid, and private insurers.

Value-chain role

Fractyl Health is a device developer and clinical-stage sponsor. It designs the Revita DMR system, conducts and funds clinical trials, and will seek regulatory approval before any commercial manufacturing or sales. The company has no disclosed commercial manufacturing or distribution partners in the filing excerpts.

Geographic exposure

Clinical trials have been conducted in the U.S. and in multi-center settings. The company faces data privacy obligations under U.S. federal and state law (including CCPA), EU GDPR, and UK GDPR, indicating some operational or data-processing activity in European jurisdictions. No commercial geographic revenue mix is disclosed.

Source: SEC 10-K, filed 2026-03-24

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