Fractyl Health (GUTS) Status update summary

Market opportunity and unmet need

• 29 million U.S. adults use GLP-1s for weight loss, but 65% discontinue within a year, leading to rapid weight regain and no FDA-approved therapy for maintenance.

• About 4 million U.S. patients are clinically eligible for Revita, representing a $40-120 billion total addressable market at $10,000-$30,000 per procedure.

• Major payers, including Medicare and large commercial insurers, already cover obesity procedures, providing reimbursement tailwinds.

• Revita is positioned as a one-time, outpatient, endoscopic procedure to maintain weight loss after GLP-1 discontinuation, with a robust safety and efficacy profile.

Clinical evidence and regulatory pathway

• Revita retains 78-84% of GLP-1-induced weight loss at one year, with significant reduction in weight regain versus sham in open-label and randomized trials.

• No device-related serious adverse events observed; safety profile supports outpatient use at scale, with only mild, transient side effects.

• Revita has FDA Breakthrough Device designation and CE mark in the EU/UK.

• Pivotal REMAIN-1 trial top-line six-month data expected early Q4 2026, with De Novo FDA submission planned for late Q4 2026 and regulatory milestones mapped through 2028.

• Favorable FDA pre-submission feedback supports Class II De Novo pathway.

Commercial strategy and launch plan

• Commercialization focuses on activating existing high-volume metabolic centers of excellence with trained metabolic interventionalists and established infrastructure.

• Initial launch targets 30-50 centers in year one, expanding to 100-200 centers over three years, with high site-level procedure volumes (250-500/year).

• Training leverages existing endoscopic skills, requiring only a half-day didactic and a few supervised cases; validated programs already in place.

• Commercial field team will be small and focused, supporting a capital-light, scalable model.