Press Releases

Feb 1, 2021

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

- Revita® DMR, combined with GLP-1RA medication, enables 53% of patients with type 2 diabetes to discontinue and remain off insulin for 18 months -
- Results are published in peer-reviewed journal Gastrointestinal Endoscopy -

Aug 6, 2020

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

Revita® DMR is the first and only procedural therapy for type 2 diabetes; Revita DMR has been shown to durably improve blood sugar control without the need for escalating drug therapy and to reduce liver fat in NAFLD/NASH in clinical studies to date.

Jun 3, 2020

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

Revita T2Di pivotal study to evaluate the ability of Revita DMR, the first non-drug, non-surgical, disease-modifying therapy, to eliminate need for insulin injections in T2D; enrollment expected to begin in late 2020

Mar 30, 2020

Fractyl Announces New Clinical Data on the Mechanism of Revita DMR in Type 2 Diabetes

Data presented at ENDO 2020 from the randomized, sham-controlled REVITA-2 study verifies that improvements in blood glucose control (HbA1C), insulin sensitivity, and other metabolic measures seen after one Revita treatment are also associated with improved pancreatic beta-cell function. Revita is the first non-drug, non-surgical, disease-modifying therapy in clinical trials in the U.S. and commercially available in the U.K. for the treatment of type 2 diabetes.

Jan 28, 2020

Fractyl Announces First-Ever Commercial Availability of Revita for Type 2 Diabetes in Partnership with Leading UK Private Clinic

Nov 15, 2019

Fractyl Announces New Data from Revita-1 Clinical Study Showing Durable Benefits after a Single Treatment Through Two Years of Follow Up

Nov 8, 2019

Fractyl Announces Revita-2 Data Showing Revita DMR Provides Statistically Significant Improvements in Blood Glucose and Liver Fat in Type 2 Diabetes with and without NAFLD

Sep 9, 2019

Fractyl Announces Positive Topline Results in the Revita-2 Clinical Trial in Patients with Type 2 Diabetes and Nonalcoholic Fatty Liver Disease

-Successful completion of Fractyl’s first sham-controlled, multicenter clinical trial of Revita DMR to support EU commercial launch and inform U.S. pivotal clinical trial. -Revita-2 data support Revita DMR as a non-pharmacological intervention that can halt and even reverse progression of metabolic diseases, including type 2 diabetes and NAFLD, of which the more serious condition is nonalcoholic steatohepatitis (NASH)

Jun 8, 2019

Fractyl’s Revita DMR Same-Day Therapeutic Procedure Could End Daily Insulin Injections for Type 2 Diabetes Patients

Interim clinical data to be presented at ADA 2019 show that approximately 85 percent of patients are insulin-free at six months after Revita DMR outpatient therapy

Apr 4, 2019

Fractyl Announces New Clinical Data Showing Same-Day Procedure Can Benefit Both NAFLD/NASH and Type 2 Diabetes

Minimally invasive therapy lowered hepatic fat by 36% and Hb1AC levels by 1% in patients with non-alcoholic fatty liver disease and type 2 diabetes

Mar 18, 2019

Fractyl Expands Management Team as Company Initiates U.S. Clinical Trial in Type 2 Diabetes

Jun 23, 2018

Fractyl Announces Presentation of Key Scientific Research at ADA 2018 Indicating That Modern Diets Durably Alter Duodenal Lining, Highlighting the Intestine’s Role in Type 2 Diabetes and NASH

Fractyl also announces one-year safety and efficacy data from the multicenter Revita-1 clinical trial of the Revita DMR system targeting the duodenal lining in patients with type 2 diabetes. In addition, Fractyl receives IDE approval from the FDA to initiate first U.S. clinical trial of Revita DMR in patients with type 2 diabetes.

Nov 30, 2017

Fractyl Completes $44 Million Series D Financing to Advance New Treatment for Type 2 Diabetes

GV, True Ventures, IDO Investments, and an undisclosed lead investor all join the financing syndicate as new investors Funds will be utilized to advance the development of Revita DMR, a new medical device and procedure t...

Nov 30, 2017

Fractyl Appoints Senator William W. Bradley and Dr. John Amatruda to the Company’s Board of Directors

LEXINGTON, Mass. – November 30, 2017 – Fractyl Laboratories Inc. (Fractyl) today announced the appointment of Senator William W. Bradley and Dr. John Amatruda to the company’s board of directors. Fractyl is advanci...

Oct 20, 2017

Clinical Data To Be Presented At AASLD 2017 Shows Single Revita DMR Procedure Elicits Sustained Improvements In Hepatic Indices In Type 2 Diabetes Patients Through 12 Months

LEXINGTON, Mass., October 20, 2017 – Fractyl Laboratories Inc. (Fractyl) today announced that clinical investigators for the Revita-1 clinical trial today will present 12-month data from the study showing sustained imp...

Sep 12, 2017

Fractyl and Collaborators Present One-Year Data on Revita DMR in Type 2 Diabetes at EASD 2017

LEXINGTON, Mass., September 12, 2017 – Fractyl Laboratories Inc. (Fractyl) and clinical investigators for the Revita-1 clinical trial today report one-year data from the study showing sustained improvement in glycemic ...

May 23, 2017

Fractyl Announces Initiation of Multicenter Clinical Trial to Evaluate a Novel Medical Procedure for Poorly Controlled Type 2 Diabetes

LEXINGTON, Mass. – May 23, 2017 – Fractyl Laboratories Inc. (Fractyl) today announced that the first patient in Europe has been treated as part of a clinical trial called Revita-2. The trial is designed to evaluate t...

Nov 11, 2016

Fractyl Presents New Revita DMR Liver Data in Type 2 Diabetes at AASLD 2016

Improvements to insulin sensitivity, hepatic transaminase levels and anti-inflammatory markers

Aug 12, 2016

Fractyl’s Revita DMR Significantly Improves Hyperglycemia in Type 2 Diabetes Patients

Hydrothermal duodenal mucosal resurfacing results published in current issue of Diabetes Care

Jun 10, 2016

Fractyl Presents Additional Mechanistic Data at American Diabetes Association Annual Meeting

Duodenal Mucosal Resurfacing Improves Broad Metabolic Measures in Type 2 Diabetes

Apr 16, 2016

Fractyl Announces CE Mark Approval for Revita DMR at EASL 2016

Also presents new data in patients with type 2 diabetes and fatty liver disease

Nov 19, 2015

Fractyl Announces Completion of $57 Million Series C Investment

Deerfield Capital Joins Existing Investor Group

WALTHAM, MA. – November 19, 2015 – Fractyl Laboratories, Inc. (Fractyl) today announced the extension of their $40M series C investment with $17M of additional funding. Total investment in Fractyl’s round C financi...

Oct 14, 2015

FierceMedicalDevices Names Fractyl Laboratories a “Fierce 15” Med Tech Company of 2015

WALTHAM, MA. – October 14, 2015 – Fractyl Laboratories, Inc. (Fractyl) today announced that FierceMedicalDevices has named the Company a 2015 Fierce 15 medical technology companies, designating Fractyl as one of the ...

Sep 18, 2015

Fractyl Announces Positive Results from 39-Patient Study of Revita DMR System

Significant changes in blood sugar control in patients with uncontrolled type 2 diabetes

Jan 16, 2015

First Patients Enrolled in Multicenter Clinical Trial of Fractyl Revita DMR System

Trial will evaluate implant-free duodenal mucosal resurfacing for type 2 diabetes

Jan 12, 2015

Fractyl Laboratories to Present at the Piper Jaffray 26th Annual Healthcare Conference

Jan 12, 2015

Fractyl Labs Announces Approval to Initiate Multicenter Clinical Trial of Revita DMR Procedure

Emergent Medical Partners Joins Existing Fractyl Investor Syndicate

Sep 4, 2014

Fractyl Labs Announces Positive Clinical Data for First Procedural Therapy to Treat Type 2 Diabetes

Mithril Capital Management Leads $40M Series C Financing to Join Early Investors General Catalyst, Bessemer and Domain Associates Trial Shows Revita™ Duodenal Mucosal Resurfacing™ (DMR) Procedure Dramatically Improves Glucose Control in Patients with Type 2 Diabetes

The press releases contained in this section of the website are provided for historical purposes only. The information contained in each press release is accurate only as of the date each press release was originally issued. Fractyl disavows any obligation to update the information contained in such press releases after the date of their issuance.

Media Contact: Lisa Raffensperger, Ten Bridge Communications, lisa@tenbridgecommunications.com, +1 (617) 903-8783

Feb 1, 2021

LEXINGTON, Mass., February 1, 2021 – Fractyl Laboratories Inc. (Fractyl), a life sciences company dedicated to novel therapeutic interventions that can reverse the metabolic disease epidemic, today announced the publication of clinical results from the investigator-initiated INSPIRE clinical trial conducted in collaboration with Fractyl. The results demonstrate that a majority of patients with type 2 diabetes treated with a combination of Revita® DMR and a glucagon-like peptide-1 receptor agonist (GLP-1RA) were able to discontinue and remain off insulin therapy for 18 months after treatment. Additionally, all treated patients showed significant improvements in measures of glucose regulation and metabolic health.

Aug 6, 2020

LEXINGTON, Mass., August 6, 2020 – Fractyl Laboratories Inc. (Fractyl), a life sciences company dedicated to novel therapeutic interventions that can reverse the metabolic disease epidemic, today announced a first close of $55 million in a Series E financing. The financing was led by new investor Taiwania Capital Management Corporation and included returning investors Bessemer Venture Partners, General Catalyst, Domain Associates, Mithril Capital Management, Emergent Medical Partners, True Ventures, and GV. New investors, Catalio Capital Management, CDIB Venture Capital Corp., and YJ Capital, also participated in the round. Michael Huang, Managing Partner at Taiwania, will join Fractyl’s Board of Directors in conjunction with the financing.

Jun 3, 2020

LEXINGTON, Mass., June 3, 2020 — Fractyl Laboratories Inc. (Fractyl) today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) to begin a pivotal study of RevitaⓇ DMR in type 2 diabetes (T2D) patients treated with insulin. This landmark pivotal study, called Revita T2Di, is a prospective, randomized, double-blind, sham-controlled study enrolling 300 patients at up to 35 sites around the world, with approximately 25 sites in the United States. Revita T2Di aims to examine the effect of Fractyl’s Revita DMR (duodenal mucosal resurfacing) treatment on glycemic control and insulin requirements. The primary endpoint of the study will be the percentage of patients who are able to achieve target glycemic control (HbA1c less than or equal to 7%) without the need for insulin at 24 weeks, comparing Revita DMR to the sham arm.

Mar 30, 2020

LEXINGTON, Mass., March 30, 2020 — Fractyl Laboratories Inc. (Fractyl) today announced clinical data that elucidate the mechanisms behind the beneficial effects and significant improvements in metabolic disease parameters for type 2 diabetes patients after one Revita® duodenal mucosal resurfacing (DMR) treatment. The data, including results from a mixed meal tolerance test, was accepted for presentation at the Endocrine Society’s annual meeting, ENDO 2020 (cancelled due to the COVID-19 pandemic) and will be published in a special supplemental section of the Journal of the Endocrine Society. This clinical data was featured as a “Breakthrough in Diabetes” at today’s webcast news conference hosted by the Endocrine Society.

Jan 28, 2020

LEXINGTON, Mass., January 28, 2020 — Fractyl Laboratories Inc. (Fractyl) today announced its first commercial partnership with HCA Healthcare UK (United Kingdom), making its Revita® treatment commercially available for the first time for patients with type 2 diabetes. HCA Healthcare UK is the largest provider of privately funded healthcare in the UK and is part of the US-based HCA Healthcare, the world’s largest private hospital group.

Nov 15, 2019

LEXINGTON, Mass., November 15, 2019 — Fractyl Laboratories Inc. (Fractyl) today announced that the company will present positive results from the long-term follow-up from the Revita-1 study2 at the Diabetes Technology Meeting taking place in Bethesda, Md. The data shows that patients experienced a 1% reduction in HbA1c (from a baseline HbA1c of 8.5% to 7.5%; n=34; p < 0.01) through 24 months of follow-up from a single outpatient Revita DMR procedure. Durable improvements in liver biomarkers were also observed over the same length of time, indicating the potential for Fractyl’s RevitaⓇ DMR (duodenal mucosal resurfacing) to offer durable improvements in both type 2 diabetes and NAFLD/NASH for a full two years. In addition, the data shows an 80% response rate with a large magnitude reduction in responders. Patient satisfaction scores were significantly improved at 12 months and no late adverse events attributable to Revita were observed.

Nov 8, 2019

LEXINGTON, Mass., November 8, 2019 — Fractyl Laboratories Inc. (Fractyl) today announced positive results from the Revita-2 trial evaluating Revita DMR (duodenal mucosal resurfacing) for the treatment of type 2 diabetes patients with and without nonalcoholic fatty liver disease (NAFLD), of which the more serious condition is nonalcoholic steatohepatitis (NASH). The results from Revita-2, Fractyl’s first sham-controlled, multicenter clinical trial of Revita DMR, will be presented in a late-breaker oral presentation (#L02) on Monday, November 11 at 2:45 pm at The Liver Meeting® 2019, the annual meeting of the American Association for the Study of Liver Disease (AASLD) in Boston. This presentation has been recognized as ‘Best of the Liver 2019,’ a recognition that highlights the most noteworthy contributions to the scientific program at The Liver Meeting.

Sep 9, 2019

LEXINGTON, Mass., September 9, 2019 — Fractyl Laboratories Inc. (Fractyl), the leader in translating new insights in gut biology into transformative therapies for patients with metabolic diseases, today announced positive topline results from Revita-2, the first randomized, double-blind, sham-controlled, multicenter clinical trial of Fractyl’s Revita™DMR. Data from patients with type 2 diabetes (T2D) with and without nonalcoholic fatty liver disease (NAFLD) show that Revita DMR, a minimally invasive, outpatient procedural therapy that resurfaces the duodenal mucosa, is safe and effective relative to a sham procedure. Full results from the Revita-2 trial are expected to be presented at an upcoming scientific meeting.

Jun 8, 2019

LEXINGTON, Mass., June 8, 2019 — Fractyl Laboratories Inc. (Fractyl), today announced the presentation of interim data from the investigator-initiated INSPIRE clinical trial in collaboration with Fractyl showing Revita™ DMR, a same-day therapeutic procedure, can help eliminate the need for daily insulin injections for type 2 diabetes (T2D) patients. This data will be presented at the American Diabetes Association's 79th Scientific Sessions in San Francisco on Sunday, June 9 from 12 pm to 1 pm. The presentation (1156-P) is entitled, “Duodenal Mucosal Resurfacing (DMR) Combined with GLP-1-RA May Eliminate Insulin Therapy and Improve Metabolic Health in Type 2 Diabetes.”

Apr 4, 2019

LEXINGTON, Mass., April 4, 2019 — Fractyl Laboratories Inc. (Fractyl), today announced the presentation of new clinical data showing its same-day therapeutic procedure can generate significant improvements in both non-alcoholic fatty liver disease (NAFLD/NASH) and type 2 diabetes (T2D) in people with both conditions. This first-of-its-kind data will be presented at The International Liver Congress™ (ILC 2019), the EASL annual meeting, in Vienna, Austria, in a plenary session (PS-112) entitled, “Endoscopic duodenal mucosal resurfacing (DMR) improves hepatic fat fraction, glycemic and lipid profiles in type 2 diabetes,” on Friday, April 12, from 5:45 pm to 6 pm (GMT+1). This presentation has been recognized as ‘Best of ILC,’ a recogniation that highlights the most noteworthy contributions to the scientific program at ILC 2019.

Mar 18, 2019

LEXINGTON, Mass., March 18, 2019 — Fractyl Laboratories Inc. (Fractyl) today announced the hiring of Margaret Borys as Chief Commercial Officer (CCO) and Juan Carlos Lopez-Talavera, M.D., Ph.D. as Chief Medical Officer (CMO). These additions come as Fractyl is preparing for commercialization efforts outside the U.S. and has started the company’s U.S. pilot clinical trial for its lead product candidate Revita™ DMR for the treatment of type 2 diabetes and fatty liver disease.

Jun 23, 2018

Fractyl Announces Presentation of Key Scientific Research at ADA 2018 Indicating That Modern Diets Durably Alter Duodenal Lining, Highlighting the Intestine’s Role in Type 2 Diabetes and NASH

LEXINGTON, Mass. and ORLANDO, Fla., June 23, 2018 /PRNewswire/ — Fractyl Laboratories Inc. (Fractyl) today announced the presentation of breakthrough research providing the first clear mechanistic link between modern diets and their causal effect on the pandemics of insulin resistance, obesity, and metabolic diseases. In an animal model, a modern diet high in fat and sugar caused overgrowth of the duodenal mucosa and overexpression of key gut hormones from the duodenum, the first segment of the intestine. These findings suggest a role of the duodenum in insulin resistance and metabolic diseases.

Nov 30, 2017

Fractyl Completes $44 Million Series D Financing to Advance New Treatment for Type 2 Diabetes

Nov 30, 2017

Fractyl Appoints Senator William W. Bradley and Dr. John Amatruda to the Company’s Board of Directors

Oct 20, 2017

Clinical Data To Be Presented At AASLD 2017 Shows Single Revita DMR Procedure Elicits Sustained Improvements In Hepatic Indices In Type 2 Diabetes Patients Through 12 Months

Sep 12, 2017

Fractyl and Collaborators Present One-Year Data on Revita DMR in Type 2 Diabetes at EASD 2017

May 23, 2017

Fractyl Announces Initiation of Multicenter Clinical Trial to Evaluate a Novel Medical Procedure for Poorly Controlled Type 2 Diabetes

Nov 11, 2016

Fractyl Presents New Revita DMR Liver Data in Type 2 Diabetes at AASLD 2016

BOSTON, MA – November 11, 2016 – Fractyl Laboratories Inc. (Fractyl) presented two late breaking abstracts today at the 2016 annual meeting of the American Association for the Study of Liver Diseases:
Rajagopalan et al. “Endoscopic duodenal mucosal resurfacing (DMR) improves insulin sensitivity, hepatic transaminase levels and anti-inflammatory markers in type 2 diabetes subjects” (LB-34)
van Baar et al. “A single endoscopic duodenal mucosal resurfacing procedure exerts a sustained improvement in hepatic transaminase levels in a cohort of type 2 diabetes patients.” (LB-35)
The company also announced the publication of a Revita DMR case study in the inaugural issue of Video GIE.

Aug 12, 2016

Fractyl’s Revita DMR Significantly Improves Hyperglycemia in Type 2 Diabetes Patients

LEXINGTON, MA – AUGUST 12, 2016 – Fractyl Laboratories Inc. (Fractyl) announced today publication of data in the current issue of Diabetes Care from the Company’s first-in-human study of RevitaTM duodenal mucosal resurfacing (Revita DMR). “Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes: 6-Month Interim Analysis from the First-in-Human Proof-of-Concept Study” is the first comprehensive analysis and publication of data from 39 patients in the first-in-human Revita DMR trial. The results showed a significant improvement in hyperglycemia in patients with type 2 diabetes poorly controlled on one or more oral antidiabetic agents (screening HbA1c: 9.5%). Overall, Revita DMR was well tolerated with minimal gastrointestinal symptoms post procedure. In the study, DMR significantly improved glycemic control in patients with type 2 diabetes, with a predominant effect of lowering fasting hyperglycemia, suggestive of a potential insulin-sensitizing mechanism.

Jun 10, 2016

Fractyl Presents Additional Mechanistic Data at American Diabetes Association Annual Meeting

WALTHAM, MA AND NEW ORLEANS, LA – June 10, 2016 – Fractyl Laboratories, Inc. (Fractyl) announced today that new data on the Company’s Revita DMRTM System, used to perform minimally invasive duodenal mucosal resurfacing for the treatment of metabolic diseases (Revita DMR procedure), was disclosed as part of an oral presentation at the 2016 Scientific Sessions of the American Diabetes Association. The presentation, Endoscopic Duodenal Mucosal Resurfacing (DMR) Improves Metabolic Measures in Type 2 Diabetes: First-in-Human Study 6-Month Data, was made by Alan Cherrington, PhD.

Apr 16, 2016

Fractyl Announces CE Mark Approval for Revita DMR at EASL 2016

WALTHAM, MA AND BARCELONA, SPAIN – April 15, 2016 – Fractyl Laboratories, Inc. (Fractyl) announced today that the Company’s Revita DMRTM System, used to perform minimally invasive duodenal mucosal resurfacing for the treatment of metabolic diseases (Revita DMR procedure), has received European CE Mark approval. The announcement was made during a company presentation of new data in liver disease

Nov 19, 2015

Fractyl Announces Completion of $57 Million Series C Investment

Oct 14, 2015

FierceMedicalDevices Names Fractyl Laboratories a “Fierce 15” Med Tech Company of 2015

Sep 18, 2015

Fractyl Announces Positive Results from 39-Patient Study of Revita DMR System

LONDON, UK AND WALTHAM, MA. – September 28, 2015 – Fractyl Laboratories, Inc. (Fractyl) today announced results from a 39-patient, single-site, proof-of-concept study demonstrating that a minimally invasive procedure using the Revita™ Duodenal Mucosal Resurfacing™ (DMR) System produces significant, beneficial changes in blood sugar in patients with poorly controlled…

Jan 16, 2015

First Patients Enrolled in Multicenter Clinical Trial of Fractyl Revita DMR System

WALTHAM, Mass. – July 16, 2015 – Fractyl Laboratories Inc. (Fractyl) today announced that patient enrollment has begun in a multicenter clinical trial (“Revita-1” trial) being conducted in Europe and South America to evaluate the safety and performance of the Revita™ Duodenal Mucosal Resurfacing™ (DMR) System. Revita is the first non-invasive, implant free duodenal resurfacing…

Jan 12, 2015

Fractyl Laboratories to Present at the Piper Jaffray 26th Annual Healthcare Conference

WALTHAM, MA – Marketwired – Nov 26, 2014 – Fractyl Laboratories Inc., the company pioneering the first procedural therapy to directly treat the underlying digestive causes of insulin resistance in patients with type 2 diabetes, will participate in the Piper Jaffray 26th Annual Healthcare Conference taking place at The New York Palace Hotel in New York City…

Jan 12, 2015

Fractyl Labs Announces Approval to Initiate Multicenter Clinical Trial of Revita DMR Procedure

WALTHAM, Mass. – January 12, 2015 – Fractyl Laboratories Inc. (Fractyl) today announced the Company has received approval to begin enrollment in a multicenter clinical trial designed to evaluate the safety and performance of the Revita™ Duodenal Mucosal Resurfacing™ (DMR) procedure, the first procedural therapy designed to directly treat the underlying digestive causes of insulin…

Sep 4, 2014

Fractyl Labs Announces Positive Clinical Data for First Procedural Therapy to Treat Type 2 Diabetes

WALTHAM, Mass. – September 4, 2014 – Fractyl Laboratories Inc. today announced positive clinical data for the first procedural therapy to directly treat the underlying digestive causes of insulin resistance in patients with uncontrolled type 2 diabetes. The non-invasive Revita™ Duodenal Mucosal Resurfacing™ (DMR)

Media Contact: Lisa Raffensperger, Ten Bridge Communications, lisa@tenbridgecommunications.com, +1 (617) 903-8783

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