With renewed financial support from our largest shareholder, we have initiated enrollment in the
groundbreaking STEP-1 pivotal trial of EndoBarrier in the United States. This study encompasses the
traditional type 2 diabetes and obesity endpoints and captures additional data such as cardiovascular
risk markers and insulin sensitivity. In addition, this study also will measure liver fat, liver stiffness, and
CKD markers- for the first time for a pivotal trial in the United States. The STEP-1 trial will also gather
data for future biomarker development and microbiome analysis that we expect will lead to significant
future breakthroughs.
Most notably for our clinicians in Europe and the Middle East,
we are highly focused on gaining the EndoBarrier CE Mark. We
hope to have our CE Mark in the first half of 2020
we are working closely with Apollo Sugar, which is the
joint venture formed by Apollo Hospitals Group and Sanofi for
the treatment of diabetes and related comorbidities. Apollo
Hospital is the largest and highest-rated private hospital system
in India and has been a phenomenal partner as we jointly
prepare to initiate the I-STEP pivotal trial in India. This study mirrors many of the endpoints we will
gather in the U.S. STEP-1 study and is anticipated to begin enrolling in the fourth quarter of 2019
