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Duodenal Mucosal Resurfacing Articles & Analysis: Older

10 news found

Fractyl Health Receives Reimbursement Authorization in Germany for Revita DMR® System

Fractyl Health Receives Reimbursement Authorization in Germany for Revita DMR® System

Revita is designed to remodel the duodenal lining via hydrothermal ablation (i.e., duodenal mucosal resurfacing) to edit abnormal intestinal nutrient sensing and signaling mechanisms that are a potential root cause of metabolic diseases. ...

ByFractyl Health


Fractyl Health Publishes Two-Year Durability Data After a Single Revita DMR Therapeutic Procedure in Patients with Type 2 Diabetes

Fractyl Health Publishes Two-Year Durability Data After a Single Revita DMR Therapeutic Procedure in Patients with Type 2 Diabetes

The publication, “Durable Metabolic Improvements 2 Years After Duodenal Mucosal Resurfacing (DMR) in Patients with Type 2 Diabetes (REVITA-1 Study),” appeared in the January 12, 2022, online issue of Diabetes Research and Clinical Practice. ...

ByFractyl Health


Fractyl Health Provides Initial Clinical Update on Open-Label REVITA-T2Di

Fractyl Health Provides Initial Clinical Update on Open-Label REVITA-T2Di

Revita is designed to remodel the duodenal lining via hydrothermal ablation (i.e., duodenal mucosal resurfacing) to edit abnormal intestinal nutrient sensing and signaling mechanisms that are a potential root cause of metabolic diseases. ...

ByFractyl Health


Fractyl Health Announces the FDA’s Authorization of Expanding the Revitalize-1 Study’s Sample Size

Fractyl Health Announces the FDA’s Authorization of Expanding the Revitalize-1 Study’s Sample Size

In March 2021, the Revita DMR System (Revita) was granted Breakthrough Device designation from the FDA for the hydrothermal ablation of the duodenal mucosa to improve glycemic control and eliminate insulin needs in T2D patients who are inadequately controlled on long-acting insulin. ...

ByFractyl Health


Fractyl Announces Tenth Trial Site Opened in REVITA-T2Di Study of Revita DMR for Type 2 Diabetes

Fractyl Announces Tenth Trial Site Opened in REVITA-T2Di Study of Revita DMR for Type 2 Diabetes

It will evaluate the efficacy of Revita DMR (duodenal mucosal resurfacing), a first-in-class intervention targeting the role of the duodenum in metabolic disease. ...

ByFractyl Health


The Ultimate List of Attractive MedTech M&A Targets

The Ultimate List of Attractive MedTech M&A Targets

In April 2021, Fractyl scored a breakthrough device designation from FDA for Revita DMR (duodenal mucosal resurfacing), a treatment that has the potential to eliminate the need for daily insulin. ...

ByAnuncia Medical, Inc.


Fractyl Announces First Patient Enrolled in Pivotal Study of Novel Procedural Therapy Revita® DMR for Type 2 Diabetes

Fractyl Announces First Patient Enrolled in Pivotal Study of Novel Procedural Therapy Revita® DMR for Type 2 Diabetes

It will evaluate the efficacy of Revita DMR (duodenal mucosal resurfacing), a first-in-class intervention targeting the role of the intestine in metabolic disease. ...

ByFractyl Health


Fractyl Announces Publication of Clinical Results from INSPIRE Study Showing Durable Insulin-Free Glycemic Control in Majority of Patients Treated

Fractyl Announces Publication of Clinical Results from INSPIRE Study Showing Durable Insulin-Free Glycemic Control in Majority of Patients Treated

“The durable effect we’ve observed out to 18 months post-treatment is a promising indication that such an approach could provide lasting metabolic benefits.” Revita DMR (duodenal mucosal resurfacing) is a first-in-class intervention designed to reverse insulin resistance and metabolic disease progression. ...

ByFractyl Health


Fractyl Raises $55 Million in Series E Financing to Advance Revita DMR for Type 2 Diabetes

Fractyl Raises $55 Million in Series E Financing to Advance Revita DMR for Type 2 Diabetes

The proceeds from the financing will be used to support the Revita T2Di pivotal clinical trial of Revita DMR (duodenal mucosal resurfacing) for the treatment of patients with type 2 diabetes (T2D). ...

ByFractyl Health


Fractyl Announces FDA IDE Approval to Begin Pivotal Study of Revita DMR for Insulin-Treated Patients with Type 2 Diabetes

Fractyl Announces FDA IDE Approval to Begin Pivotal Study of Revita DMR for Insulin-Treated Patients with Type 2 Diabetes

Revita T2Di aims to examine the effect of Fractyl’s Revita DMR (duodenal mucosal resurfacing) treatment on glycemic control and insulin requirements. ...

ByFractyl Health

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