Fractyl Health

Fractyl Health

Company type	Public
Industry	Healthcare, Life sciences, Pharmaceutical
Founded	2010 (2010)
Founder	Harith Rajagopalan, MD, PhD; Jay Caplan
Headquarters	Burlington, Massachusetts , United States
Products	Revita (endoscopic treatment), Rejuva (gene therapy platform)
Number of employees	(reduced by about 17% in 2025; exact number not specified)

Fractyl Health is a healthcare firm located in Burlington, Massachusetts, focusing on metabolic diseases including obesity and type 2 diabetes. The company created Revita, an outpatient endoscopic treatment aimed at addressing duodenal dysfunction, alongside Rejuva, a gene therapy platform currently in preclinical stages that promotes the pancreas to generate glucagon-like peptide-1 (GLP-1).

History

Established in 2010 by Harith Rajagopalan, MD, PhD, and Jay Caplan under the name Fractyl Laboratories, the Revita device obtained CE marking approval in April 2016 and was commercially introduced in the UK by January 2020. In April 2021, the US FDA designated Revita as a breakthrough device for managing type 2 diabetes. The company adopted the name Fractyl Health in June 2021.

In April 2022, the FDA authorized an investigational device exemption trial for Revita, with commercial distribution expanding to Germany by early 2023. Additional FDA breakthrough device designation was granted to Revita in July 2024 for weight maintenance in selected patients with type 2 diabetes or obesity.

Fractyl launched its initial public offering on the Nasdaq in February 2024. By early 2025, the REMAIN-1 clinical trial was underway to assess Revita’s efficacy in weight maintenance following GLP-1 therapy. In January 2025, Fractyl redirected its research priorities toward obesity and patients undergoing GLP-1 treatments, reflecting increasing market demand. This strategic shift included reducing the workforce by about 17%, mainly impacting personnel involved in type 2 diabetes treatment development.

Products

Fractyl develops treatments targeting fundamental causes of metabolic conditions such as obesity.

Revita

Revita is an outpatient endoscopic intervention that renews the duodenal mucosal surface through water and heat ablation. Prolonged consumption of high-fat and high-sugar diets can thicken this mucosal layer, impairing gastrointestinal signaling and contributing to metabolic disorders. The resurfacing process encourages regeneration of healthy mucosa, which may enhance blood glucose control and insulin sensitivity.

Rejuva

Rejuva is a gene therapy platform utilizing adeno-associated virus (AAV) vectors to stimulate continuous GLP-1 production in the pancreas by targeting malfunctioning beta islet cells, aiming to treat obesity and type 2 diabetes. The delivery method involves injecting viral vectors directly into the pancreas via a needle catheter.

In January 2025, Rejuva completed preclinical in vivo testing and initiated first-in-human clinical trials scheduled for the first half of 2025.