GI Dynamics Announces Approval of the I-STEP Clinical Study in India

BOSTON & HYDERABAD, India--( )-- GI Dynamics Inc., a medical device company that isBUSINESS WIRE
developing the EndoBarrier® System for patients diagnosed with type 2 diabetes and obesity, is pleased to
announce that it has received regulatory approval to begin enrollment in the I-STEP clinical trial in India.

I-STEP is a multi-center, randomized, pivotal study evaluating the safety and efficacy of EndoBarrier® for glycemic
improvement in patients with inadequately controlled type 2 diabetes and obesity and will be conducted exclusively
in partnership with the Apollo Hospital System and Apollo Sugar Clinics. This study, which is intended to follow 100
subjects up to 24 months, will evaluate EndoBarrier® in patients who fall within a predetermined hemoglobin A1c
range. All enrolled patients will follow a moderate intensity lifestyle and receive dietary counseling, along with
standard practice medication management