GI Dynamics president & CEO Scott Schorer told MassDevice.com today during a telephone interview that the suspension is not a recall and does not involve the safety or efficacy of EndoBarrier, a plastic gut liner designed to treat obesity and diabetes.
“It’s just an accumulation of lots of little things and some bigger things,” Schorer told us. “We’ve been trying to fix everything.”
Schorer, a medical device veteran with stints as an executive or advisor at a raft of companies under his belt, has made a number of changes at GI Dynamics since taking over in March 2016. Brought on after a higher-than-expected rate of liver abscesses forced the halt of a clinical trial in 2015, it wasn’t long before he instituted a 30% cut to the workforce in an effort to cut the company’s cash burn as it pursues FDA approval for the EndoBarrier.
The changes also included a reboot for the C-suite; Schorer tapped ex-Oxigene and HemaSure finance chief Jim Murphy to be CFO and recruited ex-Johnson & Johnson (NYSE:JNJ) and Covidien exec Brian Callahan as chief compliance officer. Today he told us that the new management team, knowing it had a long list of compliance issues to address right off the bat, initially focused on the highest-priority items – patient safety and data integrity.
“We got all that working, essentially for the 1st time,” he said, noting that the notified body’s observations concerned older “documents in the [quality] system we just haven’t had a chance to clean up yet.”
“It has to do with how the [standard operating procedures] are written and whether we’re in compliance with them,” Schorer said. “We expect to get all this resolved within 90 days.”
Knowing that a CE Mark suspension was a possibility, he added, the company moved 5 to 6 months worth of inventory to its customers “so they have uninterrupted service.”
“We hired a chief compliance officer with experience in these matters as well as quality and regulatory experts to help us address the issues while maintaining compliant surveillance and vigilance,” Schorer said in prepared remarks. “We have made significant progress over the past year and are focused on continuous improvement to the quality management system.”