Fractyl Health (NASDAQ:GUTS) said its Revita endoscopic procedure showed durable weight-maintenance results one year after patients discontinued GLP-1 therapy, while the company reaffirmed plans to report pivotal trial data in early fourth-quarter 2026 and pursue a potential FDA De Novo submission later in the year.
Chief Executive Officer Dr. Harith Rajagopalan said the company’s strategy is centered on offering patients a one-time procedural option to help maintain weight loss after stopping GLP-1 medicines. He cited the company’s July 15 release of one-year randomized data from the midpoint cohort of the REMAIN-1 study.
Fractyl also pointed to findings from its open-label REVEAL-1 cohort, where participants maintained about 78% of prior weight loss through one year after a single Revita procedure. Rajagopalan said the results address the question of whether Revita produces sustained separation from sham treatment or merely delays weight regain.
REMAIN-1 Pivotal Trial Progress
The company completed randomization in February for the REMAIN-1 pivotal cohort, enrolling more than 300 participants at more than 30 sites with more than 20 operators. Rajagopalan described the study as the largest sham-controlled gastrointestinal endoscopy pivotal trial for a novel therapeutic device.
The pivotal trial was designed to enrich for two factors associated with a greater treatment effect in earlier data: complete ablation and greater run-in weight loss. The pivotal cohort had a median ablation length of 16 centimeters and a mean run-in weight loss of 18.3%, management said.
REMAIN-1 has two co-primary endpoints. The first measures the difference between Revita and sham in percentage of total body weight regained at six months. The second is a responder endpoint requiring at least 50% of patients to maintain at least 5% total body weight loss at 12 months, based on an FDA-mandated performance goal.
Rajagopalan said Fractyl estimates both endpoints are powered above 95% based on data generated to date. In the midpoint cohort, 73% of patients in the modified intent-to-treat population met the 12-month responder threshold, while the rate exceeded 90% among patients receiving complete ablations.
The company said retention in the pivotal study remains above 90%, medication resumption is below its modeled assumptions, and blinded adverse-event trends remain consistent with prior studies. The final six-month study visit was scheduled for August, with database lock expected in the following weeks.
Fractyl expects to report top-line six-month primary endpoint results in early Q4 2026 and top-line 12-month data in the first quarter of 2027. Rajagopalan said the final statistical analysis plan has been submitted to the FDA, and agency correspondence related to it concerned detailed elements rather than material issues.
Regulatory and Commercial Plans
Management said it has received FDA feedback indicating that Revita’s safety profile is consistent with a moderate-risk device classification rather than a high-risk classification. The company continues to target a potential De Novo marketing submission in late Q4 after the six-month pivotal data readout, although Rajagopalan said the FDA will make its final pathway determination after reviewing the complete safety dataset.
Through one year in the REMAIN-1 midpoint cohort, Fractyl reported no device- or procedure-related serious adverse events. There were four mild treatment-emergent adverse events, all of which resolved within two days, according to management.
Rajagopalan said the company believes Revita could qualify for CMS transitional pass-through payment upon regulatory clearance because it holds breakthrough device designation and, in the company’s view, meets novelty and pricing-related criteria for the program. He said the applications are reviewed on a quarterly cycle and that Fractyl believes the mechanism could support reimbursement from the time of launch if the device is cleared.
For commercialization, Fractyl plans a targeted center-of-excellence model focused initially on major health systems and endoscopy centers. Rajagopalan said the top 100 to 200 endoscopy health systems perform at least half of U.S. endoscopies. He said the company expects that a focused commercial team could support high-throughput centers with existing bariatric and metabolic endoscopy capabilities.
The CEO said physicians generally became comfortable with the procedure in fewer than five cases in company studies, supported by a preceptorship model. He added that Revita uses skills endoscopists already possess and is intended to be a one-time, non-anatomy-altering intervention.
Rejuva Program Advances Internationally
Fractyl also reported progress for Rejuva, its gene-therapy platform. During the second quarter, the company received clinical trial authorization in the Netherlands for a Phase I/II first-in-human study of RJVA-001 and later received ethics committee approval in Australia.
RJVA-001 is designed as a one-time beta cell-targeted gene therapy intended to enable nutrient-responsive GLP-1 expression in the pancreas. The candidate is delivered through an endoscopic ultrasound-guided infusion. Management said the initial trial will focus primarily on safety, tolerability, and the feasibility and safety of pancreatic delivery.
The study uses staggered sentinel dosing, with the first participant monitored for at least 14 days before additional patients in that cohort can be dosed. Fractyl expects to dose the first patient after site activation and enrollment and plans to report preliminary data in the second half of 2026. Rajagopalan said the company does not yet have a timeline for seeking an FDA investigational new drug application for Rejuva.
Second-Quarter Financial Results
Chief Financial Officer Lara Smith Weber said second-quarter research and development expense was $13.8 million, down from $21.2 million a year earlier, primarily due to lower spending on the Revita and Rejuva programs. Selling, general and administrative expense increased to $5.3 million from $4.9 million, driven mainly by higher stock-based compensation.
Fractyl reported a net loss of $25.5 million for the quarter, compared with a $27.9 million net loss in the prior-year period. Adjusted EBITDA was negative $16.3 million, improving from negative $24 million a year earlier.
As of June 30, Fractyl had $47.1 million in cash and cash equivalents. Cash used in operations totaled about $16 million during the second quarter. Management said its cash runway extends into early 2027, beyond the anticipated pivotal data readout and through a potential late-Q4 De Novo submission. The company said its at-the-market facility remains closed and that it does not plan to raise capital before pivotal data are available.
About Fractyl Health (NASDAQ:GUTS)
Fractyl Health, Inc is a clinical-stage medical technology company focused on the development and commercialization of minimally invasive, endoscopic therapies for metabolic diseases. Headquartered in Lexington, Massachusetts, Fractyl is advancing treatments that target the underlying physiology of conditions such as type 2 diabetes, obesity and nonalcoholic fatty liver disease (NAFLD) by modifying the duodenal mucosa to improve metabolic control.
The company’s lead product, Revita® Duodenal Mucosal Resurfacing (Revita DMR), employs a catheter-based hydrothermal ablation technique to remodel the lining of the upper small intestine.
