Fractyl Health reported that its Revita duodenal mucosal resurfacing procedure achieved sustained weight maintenance in a 6‑month open‑label cohort. Seventeen participants, who had previously lost an average of 24 % of body weight on GLP‑1 therapies, experienced a mean weight change of only 1.5 % after discontinuing the medication and receiving a single Revita treatment.
The 1.5 % weight change is markedly lower than the approximately 10 % weight regain observed in historical control populations that discontinue GLP‑1 drugs. This comparison underscores the procedure’s potential to provide a durable, drug‑free strategy for patients who have achieved significant weight loss but struggle to maintain it once therapy stops.
Revita’s mechanism—hydrothermal ablation of the duodenal lining—aims to reset metabolic signaling pathways. The REVEAL‑1 data suggest that the intervention can preserve metabolic benefits long after GLP‑1 therapy ends, addressing a critical unmet need in obesity and metabolic disease management.
The company’s FDA Breakthrough Device designation for Revita in the weight‑maintenance indication accelerates the regulatory review process and signals strong confidence in the device’s clinical value. The designation also positions Fractyl for potential reimbursement pathways that could broaden market access.
Financially, Fractyl remains a pre‑revenue, clinical‑stage company. Q3 2025 net loss was $45.6 million, up from $23.2 million in Q3 2024, while full‑year 2023 revenue was $0.12 million and 2024 revenue was $93,000. The company has raised capital to extend its cash runway into early 2027, but continued funding will be required to support ongoing clinical development and eventual commercialization.
Fractyl’s next milestones include the REMAIN‑1 midpoint data, expected in January 2026, and a potential Premarket Approval filing later in 2026. These events will provide further evidence of Revita’s efficacy and safety in a larger, randomized cohort and could accelerate market entry.
CEO Harith Rajagopalan emphasized that the results “demonstrate the potential of Revita to deliver durable, drug‑free weight maintenance and transform care from chronic management to a more sustainable metabolic health strategy.” He highlighted the urgency of addressing the growing obesity epidemic and the opportunity to reverse metabolic disease with a first‑in‑class therapy.
Market reaction to the data has been positive, with investors and industry observers noting the strong clinical signal and the strategic alignment with the company’s focus on post‑GLP‑1 weight maintenance. The announcement reinforces confidence in Fractyl’s pipeline and its potential to capture a significant share of the obesity treatment market.
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