BURLINGTON, Mass. - Fractyl Health Inc. (NASDAQ:GUTS) announced results from its REVEAL-1 study showing participants maintained approximately 78% of weight lost through GLP-1 medications one year after discontinuing the drugs and undergoing a single Revita procedure, according to a press release statement.The positive clinical news comes as the company, with a market capitalization of $121 million, faces stock volatility. Shares currently trade at $0.76, down 65% year-to-date, though analysts maintain price targets ranging from $2 to $8. According to InvestingPro data, the stock has declined 9.6% over the past week alone.
The open-label study enrolled 22 individuals with obesity who had lost at least 15% of their total body weight on GLP-1 medications. Participants had lost an average of 24% total body weight, or more than 50 pounds, while on GLP-1 therapy for periods ranging from five months to five years before enrollment.
Safety and complete efficacy data through one year were available for 22 and 15 participants, respectively. The 15 participants with complete efficacy data showed a mean total body weight change of 5.3% at one year following the Revita procedure. One-third of participants continued to lose weight at the one-year mark.
The company stated that published third-party studies report approximately 15% weight regain at similar time points after GLP-1 withdrawal alone. All 22 participants maintained at least 5% of their GLP-1-induced weight loss through one year.
The study reported minimal change in HbA1c levels of 0.08% after the Revita procedure. No procedure-related serious adverse events were observed. Mild treatment-emergent adverse events occurred in eight of 22 participants and were transient, self-limited, and occurred within the first month of treatment.
Revita received Breakthrough Device designation from the U.S. Food and Drug Administration for weight maintenance in people with obesity who discontinue GLP-1 therapies. The device is for investigational use only in the United States and is CE marked in the European Union and United Kingdom.
Fractyl Health expects one-year randomized data from the REMAIN-1 Midpoint Cohort in the third quarter of 2026 and topline six-month randomized data from the REMAIN-1 Pivotal Cohort in early fourth quarter of 2026.For deeper insights into Fractyl Health’s financial health and growth prospects, investors can access comprehensive analysis through InvestingPro, which offers detailed Pro Research Reports covering this and over 1,400 US equities.
In other recent news, Fractyl Health reported its Q1 2026 earnings, delivering a notable performance by significantly surpassing analysts’ expectations. The company achieved an earnings per share (EPS) of -$0.06, compared to the forecast of -$0.25, representing a 76% surprise. Despite reporting zero revenue, the earnings results were positively received, with strategic cost management and clinical trial advancements contributing to this outcome. Additionally, Fractyl Health announced the appointment of Mike Zumdahl as Senior Vice President of Market Access and Commercial Strategy. Zumdahl brings experience from his previous role at Inari Medical, where he played a key role until its acquisition by Stryker for approximately $4.9 billion. These developments indicate a period of strategic growth and leadership strengthening for Fractyl Health.
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