SANTA ANA, Calif.– EndoStim, a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD), recently met with the U.S. Food and Drug Administration (FDA) for a device pre-submission meeting in advance of a Premarket Approval (PMA) submission for the Company’s EndoStim System.
Following its recent Breakthrough Device Designation for the EndoStim System, the Company initiated the pre-submission request with the FDA. In the meeting, FDA officials provided constructive feedback related to EndoStim’s regulatory strategies and plans. EndoStim intends to utilize the FDA’s feedback to move forward with filing its PMA submission in 2023 requesting approval of the EndoStim System.
“We appreciate the productive and collaborative meeting with the FDA and found their feedback to be invaluable as we advance the EndoStim System toward regulatory approval,” said Eric Goorno, President and Chief Executive Officer of EndoStim. “We’re looking forward to our submission with the intent of bringing this breakthrough technology to U.S. clinicians and their patients who need new treatment options for drug-refractory GERD.”
“Drug-refractory GERD is a chronic and debilitating disease afflicting millions of Americans. EndoStim’s LESS-GERD (NCT02749071), double-blinded, sham-control, PMA trial will provide level-1 evidence for the safety and effectiveness of the LES electrical stimulation for the treatment of this disease,” added Virender K. Sharma MD, Chief Medical Officer and co-founder of EndoStim.
