This status is the highest of 4 levels, which will bring in full reimbursement for the Lexington, Mass.-based company at the 143 participating hospitals. Payers at these hospitals will be required to cover the gaps in treatment costs for the EndoBarrier procedure, according to GI Dynamics.
“The NUB 1 designation is an important step towards full reimbursement for EndoBarrier in Germany, where there is a significant need for additional therapeutic options for patients with type 2 diabetes and obesity,” president & CEO Scott Schorer said in prepared remarks. “We look forward to continuing our work with clinical teams in Germany to restore healthy blood sugar levels and achieve weight loss in this patient population.”
The company’s EndoBarrier is a minimally invasive therapy for patients with uncontrolled Type II diabetes and obesity. The EndoBarrier liner is a flexible sleeve, which is placed inside the intestine to create a barrier between ingested food and the patient’s intestinal wall.
The device works by affecting the hormones that play a key role in insulin sensitivity, glucose metabolism, satiety and food intake, GI Dynamics said.
In December, the company raised $1.1 million (AU $1.5 million) and launched an impending security purchase plan looking to raise an additional $732,006 (AU $987, 910).
GI Dynamics sold 69.9 million Chess depository interests, representing nearly 1.4 million shares of stock at 16¢ (AU 22¢) per share to investors in Australia “and other certain jurisdictions”.
In November last year, the company released German registry data on its EndoBarrier device, touting significant weight loss and lowered insulin usage among the 234 patients enrolled in the registry.
Data suggested a mean reduction in absolute HbA1c of 1.3%, as well as a reduction of anti-diabetic medication in 78% of patients. Mean injection doses of insulin were reduced by 42%, the company said.