Fractyl concentrates on Revita device, cuts 45% of staff and ends in-house Rejuva work

Fractyl Health used its third-quarter update on 12 November 2026 to reposition itself as a single-asset company. It reported positive six-month pivotal data for its Revita duodenal ablation device, while announcing it will lay off about 45% of its workforce and stop developing its Rejuva gene therapy programme internally.

The data come from REMAIN-1, which tests whether Revita helps patients keep weight off after they stop taking GLP-1 drugs. The company said the trial achieved its six-month co-primary endpoint, with a p-value of 0.0023. The facts provided do not include the size of the weight effect, so the clinical and commercial significance cannot yet be judged.

Fractyl plans to file a De Novo request with the US Food and Drug Administration towards the end of 2026, and expects 12-month REMAIN-1 results in the first quarter of 2027. By way of context, De Novo is the US route for novel devices of low to moderate risk that have no legally marketed predicate.

On payment, the American Medical Association has issued Category III CPT code 1122T, effective 1 January 2027. Category III codes are temporary and mainly track use of emerging technologies; they do not by themselves set reimbursement. Fractyl projects its cash will last into the second quarter of 2027, only a short time after the 12-month data are due.