SANTA ANA, Calif.--(BUSINESS WIRE)--EndoStim, a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD), announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System.
FDA Breakthrough Device Designation is intended to provide patients and health care providers with timely access to medical devices for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions by speeding up their development, assessment, and review while preserving the statutory standards for premarket approval or clearances.
"We are pleased that the FDA has recognized the therapeutic potential of the EndoStim System as a new treatment in development for drug refractory GERD,” said Eric Goorno, Chief Executive Officer of EndoStim. “Our goal is to bring this new therapy to patients as quickly as possible. We look forward to working closely with the FDA to expedite the review of the EndoStim System.”
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)1. 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 GERD2. GERD is estimated to affect up to 20% of the population worldwide3. 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.
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 of traditional anti-reflux surgery. The EndoStim System has been successfully investigated in multiple independent studies. For more information, visit www.endostim.com and follow on Twitter-@EndoStim4GERD and LinkedIn.
1 https://www.webmd.com/heartburn-gerd/guide/reflux-disease-gerd-1
2 https://www.mayoclinic.org/diseases-conditions/gerd/symptoms-causes/syc-20361940
3 https://aoe.amegroups.com/article/view/6041/html#:~:text=GERD%2C%20Gastroesophageal%20reflux%20disease.,a%20gastroenterology%20practice%20(14)
