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BURLINGTON, Mass. - A pilot study of Fractyl Health’s (NASDAQ:GUTS) Revita procedure has shown promising results in preventing weight regain after patients discontinue GLP-1 medications, according to data released by the company Friday. The clinical-stage medical technology company, currently valued at $73 million, has seen its stock decline 60% over the past year amid challenging market conditions. According to InvestingPro analysis, the company’s financial health score remains weak, reflecting its pre-revenue status and significant cash burn rate.
The REMAIN-1 Midpoint Cohort study found that patients treated with Revita lost an additional 2.5% of total body weight three months after stopping tirzepatide, while those who received a sham procedure regained 10% of their weight. The difference was statistically significant with a p-value of 0.014. While these clinical results are promising, InvestingPro data shows the company reported a net loss of nearly $100 million in the last twelve months, highlighting the substantial investment required to bring medical innovations to market.
The randomized, double-blind study included 45 adults with obesity who had achieved at least 15% total body weight loss with tirzepatide before discontinuing the medication. Participants were randomized 2:1 to receive either Revita or a sham endoscopic procedure.
"The treatment difference we saw in this study, with Revita patients continuing to lose weight while sham patients rapidly regained weight, is striking," said Shelby Sullivan, Professor of Medicine at the Geisel School of Medicine at Dartmouth University, in the company’s press release.
Fractyl reported that the Revita procedure demonstrated good safety and tolerability through the three-month period, with no procedure-related serious adverse events observed. Side effects were described as infrequent, mild, and transient.
Revita is designed to remodel the duodenal lining via hydrothermal ablation to address intestinal nutrient sensing and signaling mechanisms that may contribute to metabolic disease. The procedure has received FDA Breakthrough Device designation for weight maintenance in people with obesity who discontinue GLP-1 drugs.
The REMAIN-1 Midpoint Cohort study is ongoing, with six-month data expected in the first quarter of 2026. The company’s pivotal cohort has completed enrollment, with patient randomization expected in early 2026 and topline primary endpoint data anticipated in the second half of 2026.
In the United States, Revita remains for investigational use only under U.S. law.
In other recent news, Fractyl Health Inc. reported its second-quarter 2025 earnings, highlighting a notable increase in research and development expenses and a widened net loss compared to the previous year. Despite these financial challenges, the company has successfully extended its cash runway into 2026. In terms of analyst activity, Canaccord Genuity lowered its price target for Fractyl Health from $12 to $6, while maintaining a Buy rating, citing the company’s recent data and financing updates as "incremental." H.C. Wainwright also initiated coverage on Fractyl Health with a Buy rating and a $9 price target, expressing optimism about the company’s innovative approaches to addressing metabolic diseases.
Additionally, Fractyl Health announced changes to its board of directors, appointing Christopher Thompson, M.D., and Ian Sheffield as new directors. Sheffield will also serve on the board’s audit committee. Both directors will receive annual retainers and stock options as part of their compensation. These developments reflect Fractyl Health’s ongoing efforts to strengthen its leadership and financial strategies amidst evolving market conditions.
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