GI Dynamics Inc., a medical device company with offices in Lexington, said it has completed a $57.5 million private placement, and it added that it plans to use some of the proceeds to fund US trials of its EndoBarrier, a treatment for patients who have uncontrolled type 2 diabetes and who are obese.
According to the company’s website, the EndoBarrier is placed in the intestine through a small tube that is inserted through the mouth, mimicking the effects of gastric bypass, without the risks associated with surgery. As described by GI Dynamics, the device is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine.
A company video explaining how the product is designed to work is included below.
According to GI Dynamics, the EndoBarrier has already been approved by regulators in Chile, the Netherlands, the United Kingdom, Germany, Austria, Australia, and Israel.
“We are very pleased with the successful completion of this financing,” Stuart A. Randle, chief executive of GI Dynamics, said in a statement. “With the FDA’s approval last year to allow us to move forward with a pivotal trial in the United States rather than a pilot trial, our clinical investment needs increased. This financing allows us to fully and rapidly resource our pivotal trial (The ENDO Trial) in the United States while continuing to expand our commercial footprint and sales ramp in Europe, Australia, South America, and the Middle East and build the case for reimbursement in key markets.”