Fractyl Health goes the IPO route

Fractyl Health — developer of medtech and gene therapies to reverse diabetes and obesity — began trading on the Nasdaq today under the symbol GUTS.

Lexington, Massachusetts–based Fractyl Health priced its 7,333,333 shares of common stock at $15 per share, enabling it to bring in about $110 million from the IPO.

The company expected the offering to close on Feb. 6, subject to customary closing conditions. In addition, Fractyl Health has granted the underwriters a 30-day option to purchase up to an additional 1,099,999 shares of common stock at the initial public offering price less the underwriting discounts and commissions.

The company’s technologies include its Revita system, which uses hydrothermal ablation to target the duodenum in conjunction with empagliflozin. There is also Rejuva — a one-time, durable pancreatic gene therapy designed to improve islet health.

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The biggest stories from the American Diabetes Association (ADA) 2023 Scientific Sessions

From left: the Insulet Omnipod 5, Medtronic MiniMed 780G and the Senseonics Eversense E3. These technologies were part of some of the biggest stories from the American Diabetes Associations’ 2023 Scientific Sessions. [Images courtesy of Insulet, Medtronic and Senseonics]

As it does every year, this past week, the American Diabetes Association convened its Scientific Sessions to bring together leaders in the diabetes space.

At last year’s event, next-generation technologies from the big hitters took the spotlight. The 83rd iteration this past week produced a range of new studies, product updates and positive news for a number of technologies and innovations. From continuous glucose monitors (CGMs) to insulin pumps to digital platforms and diabetes reversal procedures, ADA 2023 saw it all.

Usual suspects, like Dexcom, Abbott, Medtronic and Insulet shared their updates. Meanwhile, promising data came …

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The biggest stories from the American Diabetes Association (ADA) 2023 Scientific Sessions

From left: the Insulet Omnipod 5, Medtronic MiniMed 780G and the Senseonics Eversense E3. These technologies were part of some of the biggest stories from the American Diabetes Associations’ 2023 Scientific Sessions. [Images courtesy of Insulet, Medtronic and Senseonics]As it does every year, this past week, the American Diabetes Association convened its Scientific Sessions to bring together leaders in the diabetes space.

At last year’s event, next-generation technologies from the big hitters took the spotlight. The 83rd iteration this past week produced a range of new studies, product updates and positive news for a range of technologies and innovations. From continuous glucose monitors (CGMs) to insulin pumps to digital platforms and diabetes reversal procedures, ADA 2023 saw it all.

Usual suspects, like Dexcom, Abbott, Medtronic and Insulet shared their updates. Meanwhile, promising data came out of Senseonics, Sernova, Bigfoot Biomedical and more.<…

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Studies back Fractyl Health diabetes reversal procedure, gene therapy

Fractyl Health announced multiple studies supporting its programs for the reversal and treatment of diabetes.

Lexington, Massachusetts-based Fractyl reported data from its Revitalize 1 pivotal study and its Rejuva program. Revitalize 1 evaluates the company’s Revita endoscopic ablation procedure to reverse diabetes. Rejuva evaluates a targeted pancreatic gene therapy.

The company presented its results at the American Diabetes Association’s 83rd Scientific Sessions.

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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.

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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.

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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.

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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.

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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 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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