Fractyl Health Archives - Medical Design Sourcing

Fractyl Health ‘encouraged’ by results from diabetes reversal study

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 device exemption (IDE) trial for Revita in April 2022.

Lexington, Massachusetts-based Fractyl aims for Revita to improve glycemic control and eliminate insulin needs in type 2 diabetes patients. These patients currently suffer from inadequate control on long-acting insulin. Interim data not only showed improved glycemic control but also stronger metabolic control and reduced insulin requirement.

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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 different pharmacologies to address serious metabolic diseases, including type 2 diabetes and obesity.

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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.

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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 insulin in the Revitalize-2 IDE pivotal study.

Get the full story at our sister site, Drug Delivery Business News.

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 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 with the company’s Revita system for resurfacing the upper intestine lining (duodenal mucosa) in metabolic disease for patients with insulin-treated type 2 diabetes.

Get the full story at our sister site, Drug Delivery Business News.

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 News.

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 1922 and remains a vital part of the standard of care. World Diabetes Day falls on Nov. 14 because it is the birthday of Frederick Banting, one of the scientists involved in discovering insulin as a treatment for diabetes.

However, while many medtech companies look for ways to make insulin accessible and efficient in treating diabetes, others are innovating treatment avenues outside of insulin. Regardless of the path chosen, all have created intriguing options for managing and treating diabetes. Here are seven innovations in diabetes treatment that are worth keeping an eye on:

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

World Diabetes Day — Nov. 14 — centers around raising awareness for those who live every day with diabetes.

This year, that aim remains the same, and medical technology companies all over the world continue to look for ways to help manage the metabolic disease.

Some of those treatments involve insulin, which was discovered as a treatment for diabetes in 1922 and remains the standard of care. World Diabetes Day falls on Nov. 14 because it is the birthday of Frederick Banting, one of the scientists who helped to discover insulin as a treatment for diabetes.

However, while many medtech companies look for ways to make insulin accessible and efficient in treating diabetes, others are innovating treatment avenues outside of insulin. Regardless of the path chosen, all have created intriguing options for helping to manage and treat diabetes. Here are seven innovations in diabetes treatment that are worth keeping an eye on:

Next>>

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 at Indiana University Health. Additionally, enrollment is ongoing in Belgium, Italy and the Netherlands.

Get the full story at our sister site, Drug Delivery Business News.

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 prior (June 11). In all, the industry has risen 3.4% over the past two weeks.

The recent upswing provides a welcome sight after the industry’s progress came to a halt with a -1.4% dip earlier this month. The index looks poised to pick up again as it nears the high points registered when April brought the industry’s all-time best performance.

Even with some recent setbacks, medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered an 19.8% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus a 78.1% increase from the …

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 our sister site, Drug Delivery Business News.