Endostim

EndoStim is a medical device company developing and commercializing a first-in-class neurostimulation treatment system for drug-refractory gastroesophageal reflux disease (GERD). The EndoStim System is an implantable device designed to provide long-term reflux control by automatically delivering mild electrical signals to the patient's weak or dysfunctional lower esophageal sphincter (LES) muscle throughout the day, which is the underlying cause of GERD.

The system comprises an implantable neurostimulation device and a lead placed through a quick, minimally invasive laparoscopic procedure. It is programmed wirelessly by a physician using a handheld controller to stimulate the LES, allowing it to function normally without causing any discomfort to the patient. The EndoStim System has been successfully investigated in multiple independent studies.

In October 2022, EndoStim received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its EndoStim System, recognizing its potential as a new treatment for drug-refractory GERD. This designation aims to expedite the development, assessment, and review of the device while maintaining statutory standards for premarket approval. EndoStim acquired the breakthrough designation to bring this therapy to patients as quickly as possible.