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 First Patient Enrolled in the I-STEP Clinical Study of EndoBarrier in India

February 13, 2023 at 09:16 am EST

GI Dynamics Inc. announced the first patient in the India I-STEP clinical study has been treated at Apollo Speciality Hospital in Chennai, India in January. Apollo Speciality Hospital, OMR, Chennai, is one of four clinical study sites and is led by Dr. Usha Ayyagari, MBBS, MRCP (UK), MRCPE (Edin), CCT (Oxford, UK), FRCP (London), FRCPE (Edin), Senior Consultant in Diabetes and Endocrinology, and Dr. Bharath Kumar Mookiah, MBBS, MD, MRCP (UK), DNB, Consultant Gastroenterologist. I-STEP is a multi-center, randomized (3 EndoBarrier: 1 Control), controlled, pivotal trial of EndoBarrier in India.

The trial is designed to evaluate the safety and efficacy of EndoBarrier for glycemic improvement in patients with inadequately controlled type 2 diabetes and obesity. All enrolled patients will fall within a predetermined hemoglobin A1c range, follow a moderate intensity lifestyle, and receive dietary counseling along with standard practice medication management. The I-STEP trial's lead investigators are Dr. K. S. Soma Sekhar Rao, MBBS, MD, DM, Consultant Gastroenterologist and Hepatologist in the Department of Medical Gastroenterology and Hepatology at Apollo Hospital, Jubilee Hills, Hyderabad, and Dr. Usha Ayyagari, Senior Consultant Endocrinologist, Apollo Speciality Hospital, OMR, Chennai.

The four clinical trial sites include Apollo Hospitals/Apollo Sugar Clinics in Chennai, Hyderabad, Mumbai, and Bangalore. This is the first of 100 patients whom The company expects to be enrolled into the I-STEP trial. Patients treated with EndoBarrier will receive diabetes medication monitoring and counseling throughout the 24-month study period.

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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