GID resumes EndoBarrier shipments in EU
GI Dynamics (ASX:GID) has been cleared to resume shipments of its EndoBarrier device therapy for obesity and type 2 diabetes in Europe, after clearing up a regulatory compliance issue.
The company’s notified body in the EU suspended shipments of EndoBarrier products with a CE Mark label in October pending a review of its vigilance and reporting systems.
But GI Dynamics announced that the body has decided to allow the company to resume commercial activities with a clarification of the indications of the product.
Following a review of the company’s clinical evidence, GI Dynamics will now indicate that EndoBarrier should only be used for the treatment of patients with a body mass index equal or greater than 30 kg/m2.
The revised indication will now state that the product is used for the treatment of obese type 2 diabetes or obese patients with at least one co-morbidity who have a BMI of at least 30 kg/m2, or for obese patients with a BMI of over 35 kg/m2.
“We are pleased to have resolved the outstanding questions surrounding EndoBarrier Therapy and want to thank all shareholders for their patience during this recent period of review and remediation of matters related to our vigilance systems,” GI Dynamics CEO Michael Dale said.
“I truly believe that, as a result of this experience, we are a stronger organisation.”
GI Dynamics (ASX:GID) shares were trading 5.26% higher at $0.30 as of around 1.30 pm on Monday.
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