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fractyllaboratories

Fractyl Health touts preliminary data from diabetes reversal study

January 20, 2022 By Sean Whooley

This is the logo of Fractyl Health.

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 […]

Filed Under: Business/Financial News, Clinical Trials, Diabetes, Featured, Surgical Tagged With: Fractyl Health, fractyllaboratories

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

November 30, 2021 By Sean Whooley

This is the logo of Fractyl Health.

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 […]

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA) Tagged With: FDA, Fractyl Health, fractyllaboratories

Fractyl activates 10th clinical site in diabetes reversal tech trial

September 1, 2021 By Sean Whooley

This is the logo of Fractyl Health.

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. […]

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

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

June 16, 2021 By Sean Whooley

This is the logo of 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 […]

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

How Fractyl Health is ‘reversing’ type 2 diabetes to reduce or eliminate insulin injections

May 21, 2021 By Sean Whooley

Fractyl

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 […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured Tagged With: Diabetes, fractyllaboratories

FDA grants breakthrough nod for Fractyl’s type 2 diabetes treatment

April 27, 2021 By Sean Whooley

Fractyl

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 […]

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

Fractyl enrolls first patient in Revita DMR treatment for Type 2 diabetes

March 22, 2021 By Sean Whooley

Fractyl

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 […]

Filed Under: Clinical Trials, Diabetes, Featured Tagged With: fractyllaboratories

Tandem’s finance chief to retire at year’s end | Personnel Moves – Dec. 8, 2017

December 8, 2017 By Sarah Faulkner

Tandem Diabetes

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 […]

Filed Under: Drug-Device Combinations, Featured, Personnel, Pharmaceuticals, Wall Street Beat Tagged With: Aerie Pharmaceuticals, avitamedical, Bellerophon Therapeutics, biofilm, Biogen Idec, fractyllaboratories, novabay, Pediapharm, Tandem Diabetes Care

Fractyl raises $44m Series D for Revita DMR tech

November 30, 2017 By Sarah Faulkner

Fractyl

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 […]

Filed Under: Clinical Trials, Diabetes, Featured, Funding Roundup Tagged With: fractyllaboratories

Fractyl Labs touts 1-year data for Revita DMR in T2D patients

September 12, 2017 By Sarah Faulkner

Fractyl

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 […]

Filed Under: Clinical Trials, Diabetes, Featured Tagged With: fractyllaboratories

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