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 […]
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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. In September, Fractyl activated the 10th clinical site in the […]
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. […]
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. According to a news […]
How Fractyl Health is ‘reversing’ type 2 diabetes to reduce or eliminate insulin injections
Fractyl Health 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 […]
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 […]
Tandem’s finance chief to retire at year’s end | Personnel Moves – Dec. 8, 2017
Tandem Diabetes Care (NSDQ:TNDM) announced today that its EVP and chief financial exec, John Cajigas, will retire at the end of 2017. The company’s SVP of finance, Leigh Vosseller, is slated to take his place effective Jan. 1. Tandem noted that Cajigas’ retirement is not due to any disagreement or problem with the company’s accounting or […]
Fractyl raises $44m Series D for Revita DMR tech
Fractyl Laboratories said today that it raised $44 million in a Series D round, led by an undisclosed investor and first-time investors GV, True Ventures and the IDO Fund. Returning investors included Deerfield Management Company, Bessemer Venture Partners and others. The company said it plans to use the round’s proceeds to fund the continued development […]
Fractyl Labs touts 1-year data for Revita DMR in T2D patients
Fractyl Laboratories touted data today showing sustained improvement in glycemic parameters after one year following a single treatment with its Revita duodenal mucosal resurfacing system in patients with Type II diabetes. “This is the first presentation of one-year data on the durability of the Revita DMR procedure in Type II diabetes. The Revita DMR procedure […]
