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Fractyl's Revita meets six-month REMAIN-1 endpoint as company plans De Novo filing and cuts 45% of staff

🇺🇸 Fractyl Health, Inc. (GUTS) · Thu 12 Nov 2026

Fractyl Health says its duodenal ablation device hit the co-primary endpoint in weight maintenance after GLP-1 discontinuation, while it restructures and drops Rejuva gene therapy.

Fractyl Health reported third-quarter results on 12 November 2026 and said its Revita duodenal ablation device met the six-month co-primary endpoint in the pivotal REMAIN-1 trial. The study looks at weight maintenance after patients stop GLP-1 therapy. The company reported a p-value of 0.0023 for the endpoint.

Fractyl intends to submit a De Novo request to the US Food and Drug Administration in late the fourth quarter of 2026, with 12-month REMAIN-1 data expected in the first quarter of 2027. As general context, the De Novo pathway is used for novel low- to moderate-risk devices that have no legally marketed predicate.

On reimbursement, the company said the American Medical Association has issued Category III CPT code 1122T, effective 1 January 2027. Category III codes are temporary codes for emerging technologies and are used to track utilisation; they do not in themselves establish payment.

Alongside the clinical update, Fractyl is cutting about 45% of its workforce and ending internal development of its Rejuva gene therapy programme. The company projects its cash runway will extend into the second quarter of 2027.

What it means for your team

  • Regulatory teams should watch for the De Novo submission in late Q4 2026 and the 12-month data due in Q1 2027, which will inform the evidence package.
  • Market-access teams can note that Category III CPT code 1122T takes effect on 1 January 2027, giving a tracking code for the procedure.
  • The projected cash runway into Q2 2027 and the 45% workforce reduction are relevant to partners and stakeholders assessing the company's capacity to support the filing.

Company's press release (SEC filing): Fractyl Health, Inc. ↗

Article written by VigiEye from the official source (Fractyl Health, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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