Fractyl Health announced today that six-month data from a study of its diabetes reversal tech demonstrated improvements in glucose control. Interim data came from the human clinical experience in Fractyl’s Revita-T2Di long-term, open-label cohort. Revita, a procedure that remodels the duodenal lining via hydrothermal ablation, has FDA breakthrough device designation. The FDA approved an investigational […]
Fractyl Health
Data backs gene therapy delivery system for treating type 2 diabetes from Fractyl Health
Fractyl Health today announced positive preclinical proof-of-concept data in an animal model for its gene therapy delivery platform for treating type 2 diabetes. The company, which develops the Revita diabetes reversal procedure, evaluated its Rejuva program. Rejuva, a novel device and AAV-mediated delivery platform, delivers gene therapy directly targeting the pancreas. This potentially embeds multiple […]
Fractyl Health forms task force to understand root causes of type 2 diabetes
Fractyl Health announced today that it created the Erase T2D task force to research type 2 diabetes in the hopes of “erasing” the condition. The academic-industry scientific partnership aims to advance research on the role of the gut in metabolic disease. This, in turn, could catalyze future discoveries on understanding and erasing type 2 diabetes. […]
FDA approves IDE trial for Fractyl Health’s diabetes reversal tech in type 2 diabetes patients
Fractyl Health announced today that it received FDA approval for an investigational device exemption (IDE) trial of its diabetes reversal platform. Lexington, Massachusetts-based Fractyl Health will evaluate its Revita treatment in patients with type 2 diabetes whose disease is inadequately controlled despite treatment with at least two antidiabetic agents (ADAs) and who are not yet on […]
Fractyl Health touts 2-year durability study for diabetes reversal procedure
Fractyl Health today announced that it published two-year durability data from its Revita-1 clinical study in Europe and South America. Lexington, Massachusetts–based Fractyl’s trial included a two-year follow-up from 34 type 2 diabetes patients who received the company’s Revita duodenal mucosal resurfacing (DMR) procedure. Get the full story at our sister site, Drug Delivery Business News.
Fractyl Health touts preliminary data from diabetes reversal study
Fractyl Health this week announced encouraging interim feasibility data from its diabetes reversal technology study. Lexington, Massachusetts–based Fractyl’s Revita-T2Di long-term open-label cohort assessed eight patients followed through at least four weeks having been treated. The company’s Revita system resurfaces the upper intestine lining (duodenal mucosa) to treat metabolic disease in patients with insulin-treated type 2 diabetes. […]
FDA authorizes expansion of Fractyl’s pivotal clinical trial for diabetes reversal tech
Fractyl Health announced today that the FDA gave authorization to expand the Revitalize-1 pivotal clinical study of its Revita DMR system. Lexington, Massachusetts-based Fractyl Health (formerly Fractyl Laboratories) can now increase the sample size of the Revitalize-1 trial (formerly Revita-T2Di trial) from 288 to 420. Get the full story at our sister site, Drug Delivery Business […]
7 diabetes treatment innovations to look out for on World Diabetes Day
World Diabetes Day — Nov. 14 — centers around raising awareness for those with diabetes. This year, that aim remains the same, and medical technology companies continue to look for ways to continue improving the management of the metabolic disease. Some of those treatments involve insulin, which was discovered as a treatment for diabetes in […]
Fractyl activates 10th clinical site in diabetes reversal tech trial
Fractyl Health announced today that it activated the 10th clinical site in its pivotal REVITA-T2Di trial in the U.S. and Europe. Lexington, Mass.-based Fractyl’s trial is enrolling patients with type 2 diabetes who are currently on insulin therapy at sites in New Jersey, Louisiana, Texas, Massachusetts and New York to add to the initial U.S. site […]
MedTech 100 roundup: Industry climbs again
The medtech industry built off a strong performance two weeks ago with another uptick in the midst of an up-and-down year. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week (June 18) at 110.64 points, producing a 0.9% rise from the 109.63-point mark set one week […]
Fractyl raises $100M for diabetes reversal tech, renamed as Fractyl Health
Fractyl Labs today announced the closing of a $100 million Series F financing round in addition to a name change to Fractyl Health. Lexington, Mass.–based Fractyl Health received contributions to the round from new investors Maverick Capital, M28 Capital and Population Health Partners, while other new and existing investors participated, too. Get the full story at […]
