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)
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 posit...
Read MoreJun 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
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...
Read MoreApr 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
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-...
Read MoreMar 18, 2019
Fractyl Expands Management Team as Company Initiates U.S. Clinical Trial in Type 2 Diabetes
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...
Read MoreJun 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.
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 d...
Read MoreNov 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...
Read MoreNov 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...
Read MoreOct 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...
Read MoreSep 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 ...
Read MoreMay 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...
Read MoreNov 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
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...
Read MoreAug 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
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 r...
Read MoreJun 10, 2016
Fractyl Presents Additional Mechanistic Data at American Diabetes Association Annual Meeting
Duodenal Mucosal Resurfacing Improves Broad Metabolic Measures in Type 2 Diabetes
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 resurfa...
Read MoreApr 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
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 t...
Read MoreNov 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...
Read MoreOct 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 ...
Read MoreSep 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
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...
Read MoreJan 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
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 Americ...
Read MoreJan 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 typ...
Read MoreJan 12, 2015
Fractyl Labs Announces Approval to Initiate Multicenter Clinical Trial of Revita DMR Procedure
Emergent Medical Partners Joins Existing Fractyl Investor Syndicate
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 perfor...
Read MoreSep 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
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 patien...
Read MoreMedia Contact: Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@litldog.com, +1.858.344.8091
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.
Read MoreJun 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.”
Read MoreApr 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.
Read MoreMar 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.
Read MoreJun 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.
Read MoreNov 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 that aims to reverse type 2 diabetes and...
Read MoreNov 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 advancing the first medical device and procedure, called...
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 improvement in hepatic and glycemic parameters...
Read MoreSep 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 parameters following a single treatment with...
Read MoreMay 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 the safety and efficacy of the Revita™ DMR System in...
Read MoreNov 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.
Read MoreJun 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.
Read MoreApr 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
Read MoreNov 19, 2015
Fractyl Announces Completion of $57 Million Series C Investment
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 financing is now $57M. New investor Deerfield Management Company, L.P. joined existing investors…
Read MoreOct 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 most promising private med tech companies in the industry…
Read MoreSep 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…
Read MoreJan 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…
Read MoreJan 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…
Read MoreJan 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…
Read MoreSep 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: Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@litldog.com, +1.858.344.8091