GI Dynamics, Inc.

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06-04	Morphic Medical Inc. Receives Approval from the U.S. Food and Drug Administration for Amendments to Certain Requirements for Its Pivotal Study	CI
2023	GI Dynamics, Inc. Announces First Patient Enrolled in the I-STEP Clinical Study of EndoBarrier in India	CI

Morphic Medical Inc. Receives Approval from the U.S. Food and Drug Administration for Amendments to Certain Requirements for Its Pivotal Study

June 04, 2024 at 02:00 am

Crystal Amber announced that Morphic Medical Inc. has received approval from the U.S. Food and Drug Administration for Morphic's application for amendments to certain requirements for its pivotal study, which is approved as a staged study. The FDA has also referenced that there are no subject protection concerns. These changes are expected to accelerate access to the key US markets for the treatments of diabetes and obesity by 18 months.

Morphic is now seeking to target sales in the US market in 2026, subject to, inter alia, successful completion of the study and trials.

Latest news about GI Dynamics, Inc.

Morphic Medical Inc. Receives Approval from the U.S. Food and Drug Administration for Amendments to Certain Requirements for Its Pivotal Study	06-04	CI
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

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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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