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. […]
Fractyl Laboratories
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 […]
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 […]
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 […]
MedTech 100 roundup: More growth ahead?
A turgid month for the medtech industry might be drifting into the past after the past week indicated a slight turnaround as summer nears. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week at 107.74 points, marking a 1.4% rise from the 106.22-point mark set one […]
How Fractyl Labs is ‘reversing’ type 2 diabetes to reduce or eliminate insulin injections
Fractyl Labs CEO Harith Rajagopalan envisions a scenario in which those with type 2 diabetes don’t have to rely on insulin injections. Insulin has long been a staple of treatment for type 2 diabetes patients who need to manage their blood sugar levels, but Rajagopalan’s aim is to go beyond that temporary fix. Trained as […]
FDA grants breakthrough nod for Fractyl’s type 2 diabetes treatment
Fractyl Laboratories announced today that it received FDA breakthrough device designation for its Revita DMR type 2 diabetes treatment. Lexington, Mass.-based Fractyl’s Revita DMR treatment is an outpatient endoscopic procedure designed to resurface the upper intestine lining (duodenal mucosa) in metabolic disease for patients with insulin-treated type 2 diabetes. Preliminary clinical findings suggest that the treatment […]
Fractyl enrolls first patient in Revita DMR treatment for Type 2 diabetes
Fractyl Laboratories announced today that it enrolled the first patient in the trial for its Revita DMR Type 2 diabetes treatment. The Revita-T2Di trial will evaluate a single Revita DMR treatment to allow patients currently on insulin therapy but with inadequate glycemic control to achieve durable insulin-free glycemic control. The company will seek to use […]
MedTech 100 roundup: Stocks were practically unchanged last week
Despite plenty of ups and downs coming in the stock market for the medtech industry, there was hardly any movement from week to week. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.6 points at the end of last week (Aug. 21). Overall, medtech stocks saw […]
DTW Podcast: Can Fractyl Labs and Cala Health go where only drugs have gone before?
In this week’s DeviceTalks Weekly podcast, co-costs Tom Salemi and Chris Newmarker walk through this week’s “Newmarker’s Newsmakers,” the Top Five #medtech stories of the week with news coming from CureVac, Avail Medsystems, ClearMask, Thermo Fisher and Bayer. We also hear from CEO Harith Rajagopalan, MD and CFO Lisa Davidson of Fractyl Laboratories, which is […]
Fractyl adds $55M Series E for Type 2 diabetes pivotal trial
Fractyl Laboratories secured $55 million for a Series E financing to continue funding a pivotal clinical trial of its potential non-drug, non-surgical treatment for Type 2 diabetes, according to the company. The capital will go toward the Lexington, Mass-based start up’s Revita T2Di pivotal clinical trial of Revita DMR (duodenal mucosal resurfacing). Revita is measuring […]
