Fractyl Health (GUTS) H.C. Wainwright 28th Annual Global Investment Conference summary

Key clinical insights

• Durable weight maintenance after GLP-1 discontinuation is a major unmet need, with most patients regaining lost weight within 12–18 months after stopping medication.

• Revita, a device-based duodenal mucosal ablation, targets gut dysfunction to restore nutrient sensing and support weight maintenance.

• Clinical studies (REVEAL-1 and REMAIN-1) show Revita enables patients to retain up to 80% of pre-Revita weight loss at one year, with some continuing to lose weight post-GLP-1.

• Sham-controlled data confirm significant reduction in weight regain, especially with complete ablations, and a strong safety profile with only mild, short-lived adverse events.

• Pivotal REMAIN-1 study is fully enrolled, with top-line six-month data expected in early Q4 2026 and a De Novo FDA submission planned for late Q4 2026.

Regulatory and commercial strategy

• Revita holds FDA Breakthrough Device Designation and is advancing toward a De Novo pathway, which is more efficient and capital-light than PMA.

• Favorable FDA feedback suggests Revita may be classified as a low to moderate risk device, supporting a faster regulatory process.

• Commercial launch will focus on centers of excellence, leveraging existing endoscopy infrastructure and a fast learning curve for practitioners.

• Reimbursement strategy includes CMS transitional pass-through payment, a dedicated CPT code under review, and anticipated Medicare coverage at launch.

• The Medicare GLP-1 Bridge Program, starting July 2026, is expected to expand the addressable patient pool as Revita approaches launch.

Financial and operational outlook

• Anticipates a high-margin, recurring revenue model with over 80% gross margins on the single-use catheter.

• $47 million in cash on hand at Q2 end is expected to fund operations through pivotal data and De Novo filing.

• Real-world registry and pivotal data will support broader commercial coverage and reimbursement.

• Launch preparations are underway, with a potential market entry 150 days after De Novo submission and review.

• No incremental capital raise is expected before pivotal data and regulatory submission milestones.