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Fractyl Health

FDA approves IDE trial for Fractyl Health’s diabetes reversal tech in type 2 diabetes patients

April 4, 2022 By Sean Whooley

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 […]

Filed Under: Clinical Trials, Diabetes, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: FDA, Fractyl Health

Fractyl Health touts 2-year durability study for diabetes reversal procedure

February 1, 2022 By Sean Whooley

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.

Filed Under: Clinical Trials, Diabetes Tagged With: Fractyl Health

Fractyl Health touts preliminary data from diabetes reversal study

January 20, 2022 By Sean Whooley

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. […]

Filed Under: Clinical Trials, Diabetes, Endoscopic, Featured Tagged With: Fractyl Health, Fractyl Laboratories

FDA authorizes expansion of Fractyl’s pivotal clinical trial for diabetes reversal tech

November 30, 2021 By Sean Whooley

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 […]

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: FDA, Fractyl Health, Fractyl Laboratories

7 diabetes treatment innovations to look out for on World Diabetes Day

November 15, 2021 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Clinical Trials, Diabetes, Drug Pumps, Drug-Device Combinations, Featured, Health Technology, Patient Monitoring, Pharmaceutical, Software / IT Tagged With: Dexcom, Diabeloop, Eli Lilly & Co., Fractyl Health, Insulet, Medtronic, Senseonics, Twin Health

Fractyl activates 10th clinical site in diabetes reversal tech trial

September 1, 2021 By Sean Whooley

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 […]

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations Tagged With: Fractyl, Fractyl Health, Fractyl Laboratories

MedTech 100 roundup: Industry climbs again

June 21, 2021 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Featured, Funding Roundup, Mergers & Acquisitions, Wall Street Beat Tagged With: Fractyl Health, Hologic, MedTech 100 Index, Merck, Organon

Fractyl raises $100M for diabetes reversal tech, renamed as Fractyl Health

June 16, 2021 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Diabetes, Featured, Funding Roundup Tagged With: Fractyl Health, Fractyl Laboratories

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