Fractyl Health Reports Potent and Durable Two-Year Real-World Outcomes with Revita® Showing Sustained Weight Loss and Improved Glucose Control After a Single Procedure
Fractyl Health (NASDAQ:GUTS) has reported compelling two-year real-world outcomes for its Revita® procedure from the Germany Real-World Registry study. The data shows a median 9.6% weight loss and 1.6% HbA1c reduction in patients with type 2 diabetes, sustained over two years after a single procedure.
The study involved 9 participants with a median baseline weight of 104 kg and HbA1c of 9.6%. After treatment, 7 out of 8 participants achieved ≥5% weight reduction, with median HbA1c improving from 9.6% to 7.0% at two years. Notably, no device or procedure-related serious adverse events were reported.
The company expects key data readouts from its pivotal REMAIN-1 study in Q3 2025, focusing on post-GLP-1 weight maintenance, with primary endpoint data anticipated in H2 2026.
Fractyl Health (NASDAQ:GUTS) ha riportato risultati convincenti a due anni nel mondo reale per la sua procedura Revita®, provenienti dallo studio del Registro Real-World in Germania. I dati mostrano una perdita di peso mediana del 9,6% e una riduzione dell’HbA1c dell’1,6% nei pazienti con diabete di tipo 2, mantenuti per due anni dopo una singola procedura.
Lo studio ha coinvolto 9 partecipanti con un peso mediano iniziale di 104 kg e un HbA1c del 9,6%. Dopo il trattamento, 7 su 8 partecipanti hanno raggiunto una riduzione del peso ≥5%, con un miglioramento mediano dell’HbA1c dal 9,6% al 7,0% a due anni. È importante sottolineare che non sono stati segnalati eventi avversi gravi correlati al dispositivo o alla procedura.
L’azienda prevede i dati chiave del suo studio pivotale REMAIN-1 nel terzo trimestre del 2025, concentrandosi sul mantenimento del peso dopo il trattamento con GLP-1, con i dati sull’endpoint primario attesi nella seconda metà del 2026.
Fractyl Health (NASDAQ:GUTS) ha reportado resultados convincentes a dos años en condiciones reales para su procedimiento Revita®, según el estudio del Registro Real-World en Alemania. Los datos muestran una pérdida de peso mediana del 9,6% y una reducción del HbA1c del 1,6% en pacientes con diabetes tipo 2, mantenidos durante dos años tras un solo procedimiento.
El estudio incluyó a 9 participantes con un peso basal mediano de 104 kg y un HbA1c de 9,6%. Después del tratamiento, 7 de 8 participantes lograron una reducción de peso ≥5%, con una mejora mediana del HbA1c de 9,6% a 7,0% a los dos años. Cabe destacar que no se reportaron eventos adversos graves relacionados con el dispositivo o el procedimiento.
La compañía espera obtener datos clave de su estudio pivotal REMAIN-1 en el tercer trimestre de 2025, enfocándose en el mantenimiento del peso post-GLP-1, con datos del endpoint primario anticipados para la segunda mitad de 2026.
Fractyl Health (NASDAQ:GUTS)는 독일 실세계 등록 연구에서 Revita® 시술에 대한 2년간의 실질적인 결과를 발표했습니다. 데이터에 따르면 제2형 당뇨병 환자에서 단일 시술 후 2년 동안 중간 체중 감소 9.6%와 HbA1c 1.6% 감소가 유지되었습니다.
연구에는 기저 체중 중간값 104kg, HbA1c 9.6%인 9명의 참가자가 포함되었습니다. 치료 후 8명 중 7명이 체중 5% 이상 감소를 달성했으며, 2년 후 HbA1c 중간값은 9.6%에서 7.0%로 개선되었습니다. 특히, 장치나 시술 관련 심각한 부작용은 보고되지 않았습니다.
회사는 GLP-1 치료 후 체중 유지에 중점을 둔 중추적 연구인 REMAIN-1 연구의 주요 데이터 결과를 2025년 3분기에 발표할 예정이며, 주요 평가변수 데이터는 2026년 하반기에 기대됩니다.
Fractyl Health (NASDAQ:GUTS) a rapporté des résultats convaincants à deux ans dans le monde réel pour sa procédure Revita® issus de l'étude du Registre Real-World en Allemagne. Les données montrent une perte de poids médiane de 9,6% et une réduction de l’HbA1c de 1,6% chez des patients atteints de diabète de type 2, maintenues pendant deux ans après une seule procédure.
L'étude a impliqué 9 participants avec un poids médian initial de 104 kg et un HbA1c de 9,6%. Après traitement, 7 des 8 participants ont obtenu une réduction de poids ≥5%, avec une amélioration médiane de l’HbA1c de 9,6% à 7,0% à deux ans. Il est à noter qu’aucun événement indésirable grave lié au dispositif ou à la procédure n’a été signalé.
La société prévoit des résultats clés de son étude pivot REMAIN-1 au troisième trimestre 2025, axée sur le maintien du poids après le traitement par GLP-1, avec des données sur le critère principal attendues au second semestre 2026.
Fractyl Health (NASDAQ:GUTS) hat überzeugende zweijährige Real-World-Ergebnisse für sein Revita® Verfahren aus der Deutschland Real-World Registry Studie veröffentlicht. Die Daten zeigen einen medianen Gewichtsverlust von 9,6% und eine HbA1c-Reduktion von 1,6% bei Patienten mit Typ-2-Diabetes, die über zwei Jahre nach einer einzigen Behandlung anhalten.
Die Studie umfasste 9 Teilnehmer mit einem medianen Ausgangsgewicht von 104 kg und einem HbA1c von 9,6%. Nach der Behandlung erreichten 7 von 8 Teilnehmern eine Gewichtsreduktion von ≥5%, wobei sich der mediane HbA1c-Wert von 9,6% auf 7,0% nach zwei Jahren verbesserte. Bemerkenswert ist, dass keine schwerwiegenden unerwünschten Ereignisse im Zusammenhang mit dem Gerät oder dem Verfahren gemeldet wurden.
Das Unternehmen erwartet wichtige Datenauswertungen seiner entscheidenden REMAIN-1 Studie im dritten Quartal 2025, die sich auf die Gewichtserhaltung nach GLP-1 konzentriert, mit primären Endpunktdaten, die für das zweite Halbjahr 2026 erwartet werden.
- Sustained median weight loss of 9.6% maintained for two years after single procedure
- Significant HbA1c reduction of 1.6% maintained through 2-year follow-up
- No device or procedure-related serious adverse events reported to date
- 87.5% of participants achieved at least 5% weight reduction
- Results consistent across both controlled studies and real-world settings
- Small sample size of only 9 participants with 2-year follow-up data
- One participant experienced 4.5% weight gain
- Three patients remained dependent on GLP-1 drugs throughout the study period
Insights
Fractyl's Revita shows sustained 9.6% weight loss and 1.6% HbA1c reduction at 2 years with single procedure, supporting long-term efficacy claims.
The 2-year German registry data for Fractyl's Revita procedure demonstrates remarkable durability in metabolic improvements with a single intervention. The median
What's scientifically noteworthy is the sustained efficacy despite minimal therapeutic adjustments after the initial procedure. This suggests Revita addresses underlying metabolic dysfunction rather than merely providing symptomatic relief. The high responder rate is encouraging, with 7 of 8 evaluated patients achieving at least
The results are especially promising given the challenging patient population: median age 62, baseline BMI of 32 kg/m², severe hyperglycemia (HbA1c
The maintenance of effects in patients concurrently using GLP-1 medications suggests potential complementary mechanisms, which could position Revita as part of a combination approach for enhanced metabolic control or as a maintenance strategy after GLP-1 therapy—exactly what their REMAIN-1 study is evaluating.
Fractyl's Revita shows promising durability data that could position it as complementary to GLP-1s in the lucrative obesity market.
The two-year German registry data represents a significant milestone for Fractyl Health (GUTS) as it demonstrates the durability of Revita's therapeutic effect with a single procedure. In today's obesity treatment landscape, durability is a critical differentiator—particularly as concerns about weight regain after GLP-1 discontinuation persist.
From a market positioning perspective, Revita's sustained
The concurrent improvement in glycemic control (HbA1c reduction of
Investors should note the upcoming catalyst timeline: midpoint data from REMAIN-1 in Q3 2025 and primary endpoint data in H2 2026. These readouts will be critical for valuation as they will more definitively establish Revita's role in the increasingly competitive obesity market. If REMAIN-1 confirms these real-world findings in a larger, randomized setting, Fractyl could establish a significant position in the high-growth obesity therapeutics space as a complementary or maintenance therapy following GLP-1 treatment.
Two-year follow-up in Germany Real-World Registry study showed median
New real-world findings are consistent with prior two-year clinical data from studies conducted outside the United States, reinforcing Revita’s potential for long-term metabolic control ahead of pivotal REMAIN-1 readouts
Company anticipates key data readouts from randomized Revita studies in post-GLP-1 weight maintenance starting in Q3 2025
BURLINGTON, Mass., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a metabolic therapeutics company focused on pattern-breaking approaches that treat root causes of obesity and type 2 diabetes (T2D), today announced 2-year follow-up data from the Germany Real-World Registry study that showed a single Revita procedure led to durable weight loss and improved glucose control in people with obesity and advanced T2D. These data underscore Revita’s potential to provide a potent and durable non-drug alternative for patients struggling with long-term metabolic control.
Two-Year Data in Germany Show Sustained Weight Loss and Glycemic Improvement in Patients with Obesity and Advanced T2D
The Germany Real-World Registry study is a prospective, post-market, clinical follow-up study to evaluate the Revita procedure in patients with inadequately controlled T2D. Participants had a baseline HbA1c between 7–
At baseline, the first 9 participants with 2 years of follow-up had a median age of 62 years, median weight of 104 kg (229 lbs.; BMI 32 kg/m²), and a median HbA1c of
After a single Revita procedure, these 9 participants achieved a median weight loss of
In this cohort, weight loss and glucose improvements began as early as one month after the Revita procedure and were sustained through 2 years of follow-up (see data table). These findings highlight the potential of a single Revita treatment to deliver durable weight maintenance in a real-world setting.
Table. Germany Real-World Registry Study Weight and Blood Sugar Data Post-Revita Procedure
| Endpoint | Baseline | 3 Months | 6 Months | 1 Year | 2 Years |
| Weight (kg) | 104 | 92 | 94 | 97 | 97 |
| HbA1c (%) | 9.6 | 7.0 | 7.0 | 7.2 | 7.0 |
Median values shown. Fractyl Health internal data, n=9.
“We now have real-world evidence that a single Revita procedure can deliver durable improvements in both weight and glucose control that last for two years,” said Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health. “These results reinforce what we saw in earlier clinical studies in people living with obesity and type 2 diabetes. The consistency of these outcomes, across both controlled studies and real-world care, speaks to the potential impact of Revita as a one-time, non-drug solution. With randomized data from our pivotal REMAIN-1 study expected in the third quarter of this year, we are moving closer to offering a new option for long-term weight maintenance after GLP-1 therapy.”
Thirty-four participants are currently enrolled in the Germany Real-World Registry study. While the study is no longer enrolling new patients, Fractyl will continue protocol-defined follow-up of participants and share outcomes on an ongoing basis.
Revita is being studied in an ongoing IDE-approved REMAIN-1 pivotal study to evaluate its potential safety and efficacy in post-GLP-1 weight maintenance. These new findings from Germany add real-world momentum to Fractyl’s upcoming pivotal trial readouts, including Midpoint Cohort data from its ongoing REMAIN-1 study, which is expected in Q3 2025, and primary endpoint data from the Pivotal Cohort, anticipated in H2 2026. Together, these clinical milestones are designed to demonstrate Revita’s potential to help maintain weight loss after GLP-1 discontinuation and inform its possible role in supporting durable metabolic outcomes for patients with obesity.
About Fractyl Health
Fractyl Health is a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including obesity and T2D. Despite advances in treatment over the last 50 years, obesity and T2D continue to be rapidly growing drivers of morbidity and mortality in the 21st century. Fractyl’s goal is to transform metabolic disease treatment from chronic symptomatic management to durable disease-modifying therapies that target the organ-level root causes of disease. The Company has a robust and growing IP portfolio, with 32 granted U.S. patents and approximately 40 pending U.S. applications, along with numerous foreign issued patents and pending applications. Fractyl is based in Burlington, MA. For more information, visit www.fractyl.com.
About Revita®
Fractyl Health’s lead product candidate, Revita, is based on the Company’s insights surrounding the potential role of the gut in obesity. Revita is designed to remodel the duodenal lining via hydrothermal ablation (i.e. duodenal mucosal resurfacing) to reverse damage to intestinal nutrient sensing and signaling mechanisms caused by chronic high-fat and high-sugar diets that are a root cause of metabolic disease. In the U.S., Revita is for investigational use only under U.S. law. Revita has U.S. FDA Breakthrough Device designation in weight maintenance for people with obesity who discontinue GLP-1 based drugs. A pivotal study of Revita in patients with obesity after discontinuation of GLP-1 based drugs, called REMAIN-1, was initiated in the third quarter of 2024 and enrollment is now complete.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our anticipated financial performance, including cash and cash equivalents, for any period of time, the promise and potential impact of our preclinical or clinical trial data, the design, initiation, timing and results of clinical enrollment and any clinical studies or readouts, communications with regulators, the potential launch or commercialization of any of our product candidates or products, the potential treatment population or benefits for any of our product candidates or products, and our strategic and product development objectives and goals, including with respect to enabling long-term control over obesity and type 2 diabetes without the burden of chronic therapies, redefining the future of metabolic disease treatment, positioning our Company at the forefront of the global opportunity for metabolic care, and the timing of any of the foregoing. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the Company’s limited operating history; the incurrence of significant net losses and the fact that the Company expects to continue to incur significant net losses for the foreseeable future; the Company’s need for substantial additional financing; the Company’s ability to continue as a going concern; the restrictive and financial covenants in the Company’s credit agreement; the lengthy and unpredictable regulatory approval process for the Company’s product candidates; uncertainty regarding its clinical studies; the fact that the Company’s product candidates may cause serious adverse events or undesirable side effects or have other properties that may cause it to suspend or discontinue clinical studies, delay or prevent regulatory development, prevent their regulatory approval, limit the commercial profile, or result in significant negative consequences; the Company’s reliance on third parties to conduct certain aspects of the Company’s preclinical studies and clinical studies; the Company’s reliance on third parties for the manufacture of sub-assembly components for Revita, and its ongoing clinical studies; the regulatory approval process of the FDA, comparable foreign regulatory authorities and lengthy, time-consuming and inherently unpredictable, and even if we complete the necessary clinical studies, we cannot predict when, or if, we will obtain regulatory approval or certification for any of our product candidates, and any such regulatory approval or certification may be for a more narrow indication than we seek; and the potential launch or commercialization of any of Company’s product candidates or products and our strategic and product development objectives and goals, and the other factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on May 13, 2025 and in our other filings with the SEC. These forward-looking statements are based on management’s current estimates and expectations. While the Company may elect to update such forward-looking statements at some point in the future, the Company disclaims any obligation to do so, even if subsequent events cause its views to change.
Contacts
Media Contact
Jessica Cotrone, Head of Corporate Communications
jcotrone@fractyl.com, 978.760.5622
Investor Contact
Brian Luque, Head of Investor Relations and Corporate Development
IR@fractyl.com, 951.206.1200
FAQ
What were the 2-year results of Fractyl Health's Revita procedure for type 2 diabetes?
How many patients achieved significant weight loss with the Revita procedure in the German study?
When will Fractyl Health (GUTS) release REMAIN-1 pivotal trial results?
What were the baseline characteristics of patients in the Revita German Registry study?
Were there any serious side effects reported with the Revita procedure?
