Fractyl Health

What Fractyl Health does

Fractyl Health (NASDAQ: GUTS) is a clinical-stage biotechnology company founded in 2014 and headquartered in Burlington, Massachusetts, developing procedural and gene-therapy interventions for obesity and type 2 diabetes. The company's lead asset, Revita, is an outpatient endoscopic Duodenal Mucosal Resurfacing (DMR) procedure that uses hydrothermal ablation via a proprietary console and single-use catheter to durably modify duodenal dysfunction, with the primary commercial indication positioned as weight maintenance following GLP-1 drug discontinuation. Its second platform, Rejuva, is a locally administered AAV-based gene therapy targeting pancreatic islet cells (lead candidate RJVA-001) intended as a one-time treatment for type 2 diabetes remission; RJVA-001 received CTA authorization in the Netherlands in May 2026 as the first gene therapy to enter clinical development for that indication. Both products are investigational; the pivotal REMAIN-1 trial has completed randomization of over 300 participants across more than 30 sites, with topline data expected in early Q4 2026 and a planned FDA De Novo marketing application for Revita in late Q4 2026.

The company's revenue model is one-time procedural and device-based: Revita would be reimbursed and sold to hospitals and gastroenterology endoscopy centers as a single-use catheter-plus-console system, while Rejuva is envisioned as a one-time gene therapy procedure. No products are commercially approved and no revenue is currently recognized; the company reported a $43.7M net loss in Q4 2025 and Q1 2026 net income of $9.2M that was driven primarily by a $30.1M non-cash accounting gain from warrant liability fair-value changes. Fractyl is pre-commercial and is actively building go-to-market infrastructure, including the June 2026 hire of an SVP of Market Access and Commercial Strategy (ex-Novo Nordisk, ex-Inari Medical) to develop reimbursement and health economics capabilities ahead of an anticipated launch. The company is publicly traded on NASDAQ under the ticker GUTS, completed approximately $83M in follow-on equity offerings in August–September 2025, held $63.2M in cash as of Q1 2026, and maintains a portfolio of more than 100 issued patents covering DMR methods, devices, and gene therapy delivery systems.

Name

Fractyl Health

Legal name

Fractyl Health, Inc.

Website

https://fractyl.com

Company type

Public

Founded year

2014

Operating status

Operating

Headcount range

101–250 employees

Short description

Fractyl Health (NASDAQ: GUTS) is a clinical-stage biotechnology company developing Revita, an outpatient endoscopic duodenal mucosal resurfacing procedure for post-GLP-1 weight maintenance, and Rejuva, an AAV-based gene therapy platform targeting pancreatic islet cells for obesity and type 2 diabetes remission.

Ownership category

akta.pro rank

Product category

Metabolic Disease Medical Devices and Gene Therapy

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

akta.pro primary industry

Cardiometabolic & Other Systemic Gene Therapies (HLAAACAI)

akta.pro secondary industries

Type 2 Diabetes Care (HLAKADAC), Diabetes (General) (HLAKADAA)

Keywords

• Metabolic disease therapeutics
• Endoscopic medical devices
• Gene therapy platform
• Obesity treatment
• Duodenal mucosal resurfacing

Headquarters

HQ city

Lexington

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Revita Commercialization: Once approved, Revita will be commercialized as a one-time endoscopic procedure for weight maintenance after GLP-1 discontinuation. Revenue will come from procedure reimbursement and device sales to healthcare facilities.
2. Rejuva Gene Therapy: Rejuva is in preclinical development as a one-time gene therapy treatment. If approved, it would generate revenue from gene therapy procedures targeting pancreatic islet cells for obesity and type 2 diabetes remission.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Fractyl Health develops two therapeutic platforms for metabolic diseases: Revita, an outpatient endoscopic Duodenal Mucosal Resurfacing (DMR) procedure using hydrothermal ablation to durably modify duodenal dysfunction for post-GLP-1 weight maintenance; and Rejuva, an AAV-based gene therapy platform targeting pancreatic islet cells to enable long-term remission of obesity and type 2 diabetes. The Revita system comprises a proprietary console with software and a single-use catheter and lineset.

Product overview

Fractyl Health is a clinical-stage metabolic therapeutics company developing two distinct therapeutic platforms: Revita and Rejuva. Revita is an outpatient endoscopic duodenal mucosal resurfacing procedure designed for weight maintenance after GLP-1 drug discontinuation. Rejuva is an AAV-based gene therapy platform in preclinical development targeting pancreatic islet cells for obesity and type 2 diabetes remission. The company also has RJVA-001, a GLP-1 gene therapy candidate for type 2 diabetes currently in Phase 1/2 clinical trials.

Differentiator

Problem solved

Functional benefit

Brands

• Revita: An outpatient endoscopic procedure designed to resurface the lining of the duodenum, targeting a root cause of obesity. Also known as Revita DMR (Duodenal Mucosal Resurfacing).
• Rejuva

Products and services

• Revita Revita is an outpatient endoscopic procedure system designed to durably modify duodenal dysfunction via hydrothermal ablation to restore metabolic health. The system comprises a Revita console with proprietary technology and software, plus a single-use Revita catheter and lineset. It is intended for weight maintenance after GLP-1 drug discontinuation in patients with obesity.
• Rejuva Rejuva is a novel, locally administered AAV gene therapy platform designed to enable the long-term remission of obesity and type 2 diabetes by targeting pancreatic islet cells. The platform reprograms metabolic hormone response in pancreatic islet cells to drive durable weight loss and long-term type 2 diabetes remission through a one-time gene therapy treatment.
• RJVA-001 RJVA-001 is an AAV-based GLP-1 gene therapy candidate for type 2 diabetes. The therapy enables pancreatic beta cells to produce GLP-1 in response to meals, delivered via a minimally invasive endoscopic procedure. It is currently in a Phase 1/2 first-in-human trial authorized in the Netherlands.

Quantifiable outcome

• Patients maintained approximately 78% of GLP-1-induced weight loss at one year after single Revita procedure, compared to ~15% weight regain typically seen after GLP-1 withdrawal alone.
• +4 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Scale indicators5 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• ReShape Lifesciences: ReShape develops endoscopic weight loss devices and procedures, including intragastric balloons, and is pursuing similar metabolic/bariatric endoscopic indications. Direct competitor in the procedural obesity treatment space where Fractyl's Revita also operates.
• USGI Medical: USGI develops incisionless endoscopic procedures for gastrointestinal conditions including bariatric/metabolic interventions. Direct competitor in endoscopic bariatric/metabolic therapy with overlapping target patient populations.
• Spatz FGIA: Spatz FGIA develops the Spatz3 adjustable intragastric balloon, a less-invasive endoscopic weight loss intervention. Comparable to Revita as a procedurally-based obesity treatment delivered via endoscopy.
• Allurion Technologies: Allurion offers the Allurion Balloon, a swallowable gastric balloon for weight loss. Direct competitor in the procedural/non-surgical weight loss space targeting the same obesity patient population as Revita.

Emerging players

• Vivani Medical: Vivani develops miniature, long-term GLP-1 implants for chronic weight management. Emerging competitor addressing the same post-GLP-1 weight maintenance problem that Revita targets, with a different delivery modality.
• Altimmune: Altimmune is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for obesity. Emerging competitor in the metabolic disease space pursuing durable weight loss solutions, with overlapping endocrinology focus.
• Kallyope: Kallyope is developing oral peptide therapeutics for obesity and metabolic disease targeting gut-brain pathways. Emerging player with overlapping focus on gut-driven mechanisms of metabolic disease, conceptually adjacent to Fractyl's duodenal-targeting approach.
• ViaCyte: ViaCyte develops stem cell-derived islet cell replacement therapies for type 1 diabetes with relevance to type 2 diabetes. Comparable as a gene/cell therapy platform targeting pancreatic islet cells, paralleling the Rejuva approach for metabolic disease.

Broad incumbents

• Eli Lilly: Lilly markets Zepbound/Mounjaro (tirzepatide) and is advancing retatrutide, dominating the GLP-1 obesity market. Broad incumbent whose continued innovation in weight-loss pharmacotherapy directly affects Revita's competitive positioning as a non-pharmacological alternative.
• Novo Nordisk: Novo Nordisk markets Wegovy/Ozempic (semaglutide) and oral semaglutide, the dominant incumbent in obesity therapeutics. The post-GLP-1 discontinuation problem that Revita addresses is created primarily by Novo's (and Lilly's) drugs, making them the primary competitive context.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/FractylHealth
• Facebookfacebook.com/FractylHealth
• LinkedInlinkedin.com/company/fractyl-health

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds11 records

Investors16 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Fractyl Health