In a presentation accompanying the release of its 2nd-quarter numbers, the Lexington, Mass.-based medical device company said it’s busy repairing its relationship with the FDA and plans to finalize a bid for another investigational device exemption during the 1st half of 2017; GI Dynamics said it hopes to begin enrollment in the IDE trial by the end of June 2017.
The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and enters the intestinal tract. A higher-than-expected rate of liver abscesses forced the halt of a U.S. trial last year.
The company managed to pare its Q2 losses despite a more than 50% top-line plunge, thanks in part to a 30% workforce cut initiated by new CEO Scott Schorer, a medical device veteran with stints as an executive or advisor at a raft of companies under his belt. Losses were down -62.0% to -$3.9 million, or -41 per share, on sales of $132,000 for the 3 months ended June 30, compared with the same period last year.
“We have made significant progress in the restructuring and rebuilding of GI Dynamics over the past quarter. Many tough decisions needed to be made in order to preserve capital and stabilize the company. These actions will allow us to refocus efforts on developing optimal clinical, regulatory, and commercial strategies for EndoBarrier. We also continue to make progress towards rebuilding relationships with regulatory agencies in Europe and Australia and towards our goal of re-engaging with the FDA,” Schorer said in prepared remarks last month.
GI Dynamics said it plans to design of the new FDA study within the constraints of its current finances; a response to Australia’s Therapeutic Goods Administration was submitted June 9, the company said.