EndoStim Concludes Pre-Submission Meeting with the FDA
EndoStim Concludes Pre-Submission Meeting with the FDA and Prepares Submission for Premarket Approval of the EndoStim System for the Treatment of Drug Refractory GERD
Santa Ana, California – January 4, 2023 – 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.
About GERD
Gastroesophageal reflux disease, also known as GERD, is a digestive disorder that affects the ring of muscle between the esophagus and the stomach, the lower esophageal sphincter (LES). GERD causes stomach acid to repeatedly flow back into the tube connecting the mouth and stomach (esophagus). This backwash (acid reflux) can irritate the lining of your esophagus. Many people experience acid reflux occasionally, but when it becomes chronic, it is known as GERD. GERD is estimated to affect up to 20% of the population worldwide. GERD can cause a range of symptoms that impact quality of life and health, including pain, regurgitation, trouble sleeping, persistent cough, vocal irritation, lung inflammation, abnormal cells and cancer risk. Approximately 1 in 3 (7.5 million) GERD patients taking high dose proton pump inhibitor (PPI) medications for GERD continue to suffer from bothersome GERD symptoms and need safe and effective therapies for control of these symptoms.
About the EndoStim System
The EndoStim System consists of an implantable neurostimulation device and lead placed via a quick, minimally-invasive laparoscopic procedure. The system is designed to provide long-term reflux control by automatically delivering mild electrical signals throughout the day to the patient’s weak or dysfunctional lower esophageal sphincter (LES) muscle (the underlying cause of GERD). The EndoStim system, programmed wirelessly by a physician using an external handheld controller, automatically stimulates the LES to allow it to function normally without any sensation to the patient.
About EndoStim
EndoStim is a medical device company developing and commercializing a first-in-class neurostimulation treatment system for drug refractory gastroesophageal reflux disease (GERD). EndoStim therapy is designed to restore normal esophageal function and preserve normal anatomy to avoid the typical gastrointestinal side effects associated with traditional anti-reflux surgery. The EndoStim System has been successfully investigated in multiple independent studies. For more information, visit Endostim.com and follow on Twitter @EndoStim4GERD and LinkedIn.
Media contact:
Kira Gordon
646-243-4920 | kira@brightpointny.com