Fractyl Health Inc
NASDAQ:GUTS
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Fractyl Health Inc
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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 signal: A clear, statistically significant dose‑response was identified between duodenal ablation length and weight‑maintenance benefit after GLP‑1 discontinuation.
Pivotal design: REMAIN‑1 pivotal is fully randomized (>300 patients, >30 sites, >20 operators), powered >90%, with co‑primary endpoints at 6 months and 1 year and prespecified dose‑response analyses.
Effect size (optimized subgroup): In patients with larger GLP‑1 run‑in loss and longer ablations, Revita patients regained 2.9% at 6 months vs 9.9% for sham (~70% reduction in regain); these patients retained ~88% of tirzepatide loss vs ~60% for sham.
Procedural standardization: Ablation length is measurable and trainable; pivotal mean and median ablation lengths are >16 cm and the company will operate to a ≥16 cm target going forward.
Regulatory path: FDA indicated Revita’s safety profile is consistent with a moderate‑risk De Novo; company plans De Novo submission in late Q4 2026 after 6‑month pivotal data.
Commercial/reimbursement: Company will file for a Category III CPT code this summer (target June); code expected effective July 1, 2027, and plans to pursue CMS pass‑through payment upon clearance.
Cash runway: Cash and cash equivalents were $81.5 million at 12/31/25 (plus $4.1 million received Jan 2026); management says this funds operations into early 2027 and through the pivotal readout and potential De Novo filing.
Other programs & timeline: Rejuva (RJVA‑001) CTAs submitted in EU and Australia; first‑in‑human dosing and preliminary data expected in H2 2026; multiple data readouts planned through Q4 2026.
