Fractyl Health Inc
NASDAQ:GUTS
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Fractyl Health Inc
Fractyl Health Inc is a US-based company operating in industry. The company is headquartered in Lexington, Massachusetts and currently employs 88 full-time employees. The company went IPO on 2024-02-02. Fractyl Health, Inc. is a metabolic therapeutics company. The firm is focused on approaches to the treatment of metabolic diseases, including type 2 diabetes (T2D) and obesity. The Revita DMR System (Revita), the Company’s lead product candidate, is an outpatient procedural therapy designed to durably modify duodenal dysfunction, a pathologic consequence of a high fat and high sugar diet, which can initiate T2D and obesity in humans. The Revita system is designed to enable durable and repeatable metabolic improvement via hydrothermal ablation of the dysfunctional duodenal mucosa to address duodenal pathology and consequent metabolic disease progression directly. The firm is involved in enrolling is pivotal Revitalize-1 study in patients with inadequately controlled T2D. The company is also developing Rejuva, a locally administered, adeno-associated virus (AAV), delivered pancreatic gene therapy (PGTx), platform. Rejuva is designed to enable long-term remission of T2D and obesity.
Fractyl Health Inc is a US-based company operating in industry. The company is headquartered in Lexington, Massachusetts and currently employs 88 full-time employees. The company went IPO on 2024-02-02. Fractyl Health, Inc. is a metabolic therapeutics company. The firm is focused on approaches to the treatment of metabolic diseases, including type 2 diabetes (T2D) and obesity. The Revita DMR System (Revita), the Company’s lead product candidate, is an outpatient procedural therapy designed to durably modify duodenal dysfunction, a pathologic consequence of a high fat and high sugar diet, which can initiate T2D and obesity in humans. The Revita system is designed to enable durable and repeatable metabolic improvement via hydrothermal ablation of the dysfunctional duodenal mucosa to address duodenal pathology and consequent metabolic disease progression directly. The firm is involved in enrolling is pivotal Revitalize-1 study in patients with inadequately controlled T2D. The company is also developing Rejuva, a locally administered, adeno-associated virus (AAV), delivered pancreatic gene therapy (PGTx), platform. Rejuva is designed to enable long-term remission of T2D and obesity.
Clinical Milestone: Fractyl reported the first randomized, double-blind, sham-controlled data showing Revita can help sustain weight loss after stopping GLP-1 drugs.
Durable Results: Revita-treated patients in the REMAIN-1 Midpoint Cohort lost an additional 2.5% of body weight, while the sham group regained about 10% after GLP-1 discontinuation, a significant difference.
German Registry: Real-world data showed patients maintained around 9% total body weight loss at 2 years, with no waning of effect, and reduced medication use.
Trial Progress: REMAIN-1 pivotal study enrollment is over 60% complete and randomization is ahead of schedule, with full enrollment expected early next year.
Financial Position: Fractyl ended Q3 with $77.7 million in cash and expects its cash runway to last into early 2027 after raising $83 million in recent offerings.
Upcoming Catalysts: Multiple key clinical readouts and potential PMA submission are planned for the next 12–18 months.
Rejuva Update: The Smart GLP-1 platform showed promising preclinical data, with first patient dosing for RJVA-001 in type 2 diabetes expected in 2026.
