GI Dynamics (ASX:GID) said today it won FDA investigational device exemption approval to launch a pivotal trial of its EndoBarrier device designed for treating patients with type 2 diabetes and obesity, pending Institutional Review Board approval.

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 to treat type 2 diabetes and obesity, the Lexington, Mass.-based company said.

The approval is a boon for the company, which has faced a number of hurdles with its device over the past few years, including shutting down an initial FDA-approved study, being pulled off the shelves in Australia and losing its CE Mark approval in the European Union.

“It’s the first good news and a positive sign of all of the hard work the team has been putting in over the last two years. This is the first sign that the results are starting to turn around, so we’re very excited about it,” CEO Scott Schorer, who took over the company in March 2016, told MassDevice.com in an interview.

Schorer, a veteran of the medical device industry, has been working to turn around the company, driven by the EndoBarrier’s potential to help individuals living with obesity and type 2 diabetes.

“There’s an extraordinary amount of support for this technology, we couldn’t let it fail, and we don’t plan on letting it fail,” Schorer said. “We’re in a much better place every week and month than the previous week and month.”

In May, GI Dynamics released results from a meta-analysis of its EndoBarrier device exploring its use in helping patients with type 2 diabetes and obesity, touting improvements in insulin resistance and positive changes in weight. Schorer said that data continues to come in from registries and long-term studies of the device showing its ability to reduce weight and hbA1c, even after the device has been removed.

“We’re seeing amazing treatment durability in a subset of the patients. Some patients don’t respond to our treatment, because no single therapy works for everyone, but those that do respond – especially the ones we call ‘super responders’ that lose more than 1.5% of their A1c at 12 months, continues for a good portion, anywhere from 40% to 70% depending on the study. It’s a very tame, but clinical benefit fo EndoBarrier well after removal, and that is at the same time that they are reducing medication,” Schorer said.

In the new trial, patients will be monitored out to two years, with investigators monitoring reductions in HbA1c at one year as a primary endpoint, Schorer said.

The trial, which is cleared to proceed through the first stage of enrollment, will make use of data gleaned from earlier studies, Schorer said, including a narrower focus on subsets of patients that would have “the greatest benefit with the least exposure to risk.”

In the initial stage, the company will look to enroll up to 67 subjects, including 50 to be implanted with the EndoBarrier and 17 for the control group. Following an interim safety report to the FDA, GI Dynamics will apply to expand the enrollment to a total of 240 patients.

Patient safety is of utmost importance to GI Dynamics, Schorer said. The trial will include a caveat that if certain specific safety events are reported, enrollment will be paused, according to a press release, while the company and the FDA conduct a safety review.

Events that could cause a pause to enrollment include a single case of hepatic abscess requiring a procedure other than image-guided fine needle aspiration or oral antibiotic therapy, three hepatic abscesses requiring oral antibiotics with or without fine needle aspiration. Other events include one instance of device-related bleeding requiring transfusion, embolization or ICU care, or three instances of endoscopic intervention including cauterization or endoscope clipping of a bleeding lesion, GI Dynamics said in a press release.

GI Dynamics said it hopes to complete enrollment for the first stage of the trial during the first half of next year, subject to its acquisition of additional financing.

The trial will also include a medical monitoring committee to evaluate diabetic medications the patients are taking during the two years they are monitored to ensure adherence to ADA guidelines, Schorer said.

“We don’t want any patient to have done poorly because they were not getting the right medical therapy,” Schorer said.

Other factors that will be monitored in the trial are cardiovascular risk reduction, blood pressure, lipids, LBL and triglycerides and other factors implicated in cardiovascular disease. Insulin resistance will also be monitored, as well as any effect on non-alcoholic liver disease and a possible microbiome analysis.

“There’s a lot of data that’s going to be coming out of this,” Schorer said. “The EndoBarrier is a phenomenal product, and it needs to be brought forward. We’ll hopefully have more good news to talk about as we move ahead.”

In June, GI Dynamics inked an approximately $1.8 million note and warrant purchase deal with Crystal Amber Fund Limited, the company’s largest shareholder.