Fractyl Health (GUTS) Morgan Stanley 24th Annual Global Healthcare Conference summary

Key clinical and regulatory updates

• Revita duodenal mucosal resurfacing targets post-GLP-1 weight maintenance, with pivotal data expected in early Q4 and a potential regulatory filing later this year.

• Revita has Breakthrough Device designation and is pursuing a De Novo pathway, aiming for U.S. clearance by late 2027 and launch in early 2028.

• The pivotal trial involves over 300 patients, with co-primary endpoints focused on weight regain at six months and durability of weight loss at one year.

• Pilot studies show 80% of GLP-1 weight loss retained at one year, outperforming control arms and pharmacological maintenance approaches.

• The statistical analysis plan incorporates ablation length and run-in weight loss, optimizing for clinically meaningful effect size.

Mechanism, safety, and scalability

• Revita is a one-hour outpatient endoscopic procedure targeting the duodenum to restore nutrient sensing and signaling.

• The procedure selectively ablates mucosa, minimizing risk to deeper structures and showing a safety profile similar to sham procedures.

• Most patients experience no symptoms; mild discomfort resolves within days, supporting broad outpatient use.

• Training leverages existing endoscopic skills, with proficiency achieved after four to five cases.

• The intervention is scalable and attractive to patients as it does not alter anatomy or require implants.

Commercial strategy and market positioning

• Initial launch targets 100-200 top bariatric centers of excellence, each managing ~2,000 GLP-1 patients annually.

• Physicians are motivated by clinical need and economic opportunity, with existing infrastructure supporting rapid adoption.

• The commercial plan leverages a focused sales force and established referral networks.

• Pricing is expected between $10,000-$30,000, with early health economic models indicating cost-effectiveness and potential cost savings.

• Early national coverage for Breakthrough Devices by CMS could significantly accelerate adoption.