Fractyl Health (GUTS) Corporate presentation summary

Market opportunity and unmet need

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

• About 4 million patients are clinically eligible for Revita, translating to a $40-120B total addressable market at $10K–$30K per procedure.

• Most patients and physicians seek a durable, non-drug solution for post-GLP-1 weight maintenance, which is currently lacking.

Revita procedure and clinical evidence

• Revita is a one-time, outpatient endoscopic procedure that ablates the duodenal mucosa, designed to maintain weight loss after GLP-1 discontinuation.

• The procedure uses familiar endoscopic skills, does not alter anatomy, and is supported by a robust IP portfolio.

• Clinical trials (REVEAL-1, REMAIN-1 Midpoint, and Pivotal) show up to 84% of GLP-1-induced weight loss retained at one year with Revita versus 46% with sham.

• Safety profile is favorable, with no device-related serious adverse events and only mild, transient periprocedural effects.

Regulatory and commercialization pathway

• Revita holds FDA Breakthrough Device designation and is pursuing a De Novo Class II pathway, with pivotal trial topline data expected early Q4 2026 and submission planned for late Q4 2026.

• Commercial launch is anticipated in early 2028, with 1,600–3,000 procedures projected by end of 2028 and 5,000–10,000 in 2029.

• The commercial strategy focuses on activating existing high-volume Centers of Excellence, leveraging current infrastructure and a small, specialized field team.