GI Dynamics, Inc.

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GIDYL

AU000000GID7

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2023	GI Dynamics, Inc. Announces First Patient Enrolled in the I-STEP Clinical Study of EndoBarrier in India	CI
2022	GI Dynamics, Inc. Announces Final Data from the ENDO Trial, Multicenter Study Demonstrating the Potential Use of EndoBarrier to Treat Type II Diabetes and Obesity	CI

GI Dynamics Inc Announces the First Patient in the United States Step-1 Clinical Trial Has Been Enrolled at Michigan Medicine in Ann Arbor, Michigan

January 27, 2020 at 07:45 pm EST

GI Dynamics Inc. announced the first patient in the United States (U.S.) STEP-1 clinical trial has been enrolled at Michigan Medicine in Ann Arbor, Michigan. Michigan Medicine is one of five clinical study sites for the STEP-1 trial; the site is led by principal investigator Allison R. Schulman M.D., M.P.H., assistant professor of gastroenterology and internal medicine. The STEP-1 trial is the randomized (3 EndoBarrier: 1 Control) controlled, double-blinded pivotal trial of EndoBarrier in the U.S. The trial is designed to measure the efficacy and safety of EndoBarrier in conjunction with lifestyle therapy and diabetes medication for the treatment of type 2 diabetes and obesity. This is the first of 67 patients whom The company expects to be enrolled into Stage 1 of the STEP-1 trial. Regardless of what treatment arm the patient is randomized into, all patients will receive identical diabetes medication monitoring and counseling throughout the 24-month study period. Results from the STEP-1 trial will support the company’s pre-market approval application for EndoBarrier to the U.S. Food and Drug Administration (FDA). The STEP-1 trial’s lead principal investigator is Christopher C. Thompson M.D., M.H.E.S. of Brigham and Women’s Hospital and Harvard Medical School in Boston, Massachusetts. The five clinical trial sites include Brigham and Women’s Hospital, Michigan Medicine, Baylor College of Medicine, Thomas Jefferson University and Surgical Specialists of Louisiana. The company anticipates full enrollment of the 67 patients by the end of 2020.

Latest news about GI Dynamics, Inc.

GI Dynamics, Inc. Announces First Patient Enrolled in the I-STEP Clinical Study of EndoBarrier in India	23-02-13	CI
GI Dynamics, Inc. Announces Final Data from the ENDO Trial, Multicenter Study Demonstrating the Potential Use of EndoBarrier to Treat Type II Diabetes and Obesity	22-06-15	CI
GI Dynamics Inc. Announces Approval of the I-STEP Clinical Study in India	22-01-31	CI
Gi Dynamics, Inc. Reports Earnings Results for the First Quarter Ended March 31, 2021	21-05-07	CI
Gi Dynamics, Inc. Reports Earnings Results for the Full Year Ended December 31, 2020	21-03-12	CI
GI Dynamics, Inc. Auditor Raises 'Going Concern' Doubt	21-03-11	CI
GI Dynamics, Inc. Announces Termination of Charles Carter as Treasurer and Secretary	21-01-15	CI
GI Dynamics, Inc. Announces Termination of Charles Carter as Chief Financial Officer	21-01-15	CI
Gi Dynamics, Inc. Reports Earnings Results for the Third Quarter Ended September 30, 2020	20-11-10	CI
GI Dynamics, Inc. Announces CEO Changes	20-11-06	CI
GI Dynamics, Inc. Announces Management Changes	20-11-06	CI
GI Dynamics, Inc. Announces Executive Changes	20-10-26	CI
GI Dynamics, Inc. Announces the Appointment of Joseph Virgilio as its Chief Operating Officer	20-10-15	CI
Transcript : GI Dynamics, Inc. - Shareholder/Analyst Call	20-09-03
GI Dynamics, Inc. Announces Board Resignations	20-08-10	CI
Gi Dynamics, Inc. Reports Earnings Results for the Second Quarter Ended June 30, 2020	20-08-07	CI
GI Dynamics, Inc. announced that it has received $0.5 million in funding from Crystal Amber Asset Management Limited	20-08-03	CI
GI Dynamics, Inc. announced that it expects to receive funding from Crystal Amber Asset Management Limited	20-08-02	CI
GI Dynamics, Inc. announced that it expects to receive $9.25 million in funding from Crystal Amber Asset Management Limited	20-07-19	CI
Transcript : GI Dynamics, Inc. - Shareholder/Analyst Call	20-06-20
GI Dynamics, Inc. announced that it has received $0.75 million in funding from Crystal Amber Asset Management Limited	20-06-17	CI
Gi Dynamics, Inc. Reports Earnings Results for the First Quarter Ended March 31, 2020	20-05-06	CI
GI Dynamics, Inc. Enters into Sixth Amendment to the Senior Secured Convertible Promissory Note	20-03-31	CI
GI Dynamics, Inc. Announces Change to Board of Directors	20-03-29	CI
GI Dynamics, Inc. Auditor Raises 'Going Concern' Doubt	20-03-26	CI

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Company Profile

GI Dynamics, Inc. is a medical device company. The Company designs and applies device and disease management solutions for the treatment of metabolic disease. The Company designs, develops, manufactures and markets medical devices for non-surgical approaches to treat type II diabetes and obesity. The Company's product, EndoBarrier, is an endoscopically-delivered device therapy, which is approved for the treatment of obese type II diabetes with body mass index (BMI) greater than or equal to 30 kilogram/square meter (kg/m2), or obese patients with BMI greater than or equal to 30 kg/m2 with greater than or equal to one comorbidities, or obese patients with BMI over 35 kg/m2. EndoBarrier is an incision-free, non-anatomy altering solution designed to specifically mimic the duodenal-jejunal exclusion created by gastric bypass surgery.

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