Fractyl Health said at the Morgan Stanley 24th Annual Global Healthcare Conference that its Revita duodenal mucosal resurfacing program is approaching key clinical and regulatory milestones. CEO and co-founder Harith Rajagopalan said top-line data from the REMAIN-1 pivotal study are expected in early Q4 2024, with the company describing Revita as a potential post-GLP-1 weight-maintenance option for people with obesity and type 2 diabetes who have already achieved substantial weight loss.
REMAIN-1 enrolled more than 300 patients who had lost more than 15% of body weight on tirzepatide, with enrichment subgroups focusing on more than 17.5% weight loss. Patients were randomized 2 to 1 to Revita or a sham procedure. The durability endpoint requires at least 50% of Revita patients to maintain at least 5% total body weight loss one year after stopping GLP-1 therapy. The company said more than 70% of patients met the durability responder analysis at one year in the midpoint readout, and about 50 Revita patients have one-year follow-up data across the REVEAL-1 open-label cohort study and REMAIN-1 midpoint data.
In earlier pilot data, patients retained about 80% of GLP-1-induced weight loss at one year, while control groups regained about 55% to 60% of lost weight. The procedure involves ablation of at least 10 centimeters of duodenal mucosa, with a target of 16 to 20 centimeters from the ampulla of Vater to the ligament of Treitz. Fractyl Health plans to submit manufacturing documentation, a design history file and six-month data in late Q4 2024 through the FDA De Novo pathway, with 12-month follow-up data expected in Q1 2025.
The company estimates U.S. clearance in late 2027 and a first U.S. launch in early 2028. It expects to target 100 to 200 of roughly 1,000 accredited bariatric centers of excellence in the United States, with each center managing about 2,000 GLP-1 patients per year. Fractyl Health said centers have reported clinical waiting lists of six to eight months, that a sales force of tens rather than hundreds should be sufficient, and that profitability could be reached within five to eight quarters after launch under conservative assumptions. The company hired Mike Zumdahl as head of commercial strategy and market access in June 2024.
Revita's expected average selling price is $10,000 to $30,000, compared with reimbursement of about $11,000 for endoscopic sleeve gastroplasty and up to $33,000 for bariatric surgery. Fractyl Health cited a market of nearly 30 million Americans on GLP-1 medicines, with roughly 1 million stopping therapy each month, and said a CMS Medicare GLP-1 bridge could add 4 million to 5 million patients next year. The company ended Q2 2024 with less than $50 million in cash, which it said extends operations through early 2027, roughly five to six months beyond the pivotal data readout. Its current ratio was 3.15, beta was 2.33, and market capitalization was about $102 million. Shares were referenced at $0.61, down 72% year to date and 12% over the prior week, with analyst price targets ranging from $2 to $8. Fractyl Health also said first patient dosing for Rejuva is expected by year-end 2024.
