Clinical Feasibility Study of a Novel Flexible, Non-occlusive GERD Treatment Device

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PROJECT SUMMARY/ABSTRACT The ultimate goal of this project is to develop the flexible, non-occlusive Ω-Cuff as a simple and safe device to treat gastroesophageal reflux disease (GERD). GERD is the inability of the lower esophageal sphincter (LES) to keep the acidic stomach content from coming back up excessively into the esophagus that can cause major discomfort, disrupting daily lives and can lead to esophagitis, Barrett's esophagus, strictures, and cancer. 40 million U.S. GERD patients manage their symptoms by life-long prescription medications such as Proton Pump Inhibitors (PPIs) of whom 16 million will need other options due to either ineffectiveness or side effects. GERD is the most expensive of all the GI diseases, with an annual U.S. healthcare cost >$12 billion and growing. Due to its risks and significant physiological perturbations, the gold standard fundoplication surgery treats <30 thousand patients. Ω-Cuff improves upon a less morbid partial fundoplication surgery by having a simpler, easier, safer and more durable treatment. A straightforward laparoscopic procedure places the Ω-Cuff directly onto the esophagus without altering anatomy or physiology. Ω-Cuff works symbiotically with the esophagus to mitigate dysphagia common to other surgical treatments, to reduce medication dependence and healthcare costs. We successfully completed the required preclinical safety tests. Ω-Cuffs were manufactured and implanted over the LES area in a 1-year, 24-pigs Good Laboratory Practice (GLP) study without adverse events. The device could be safely explanted. Ω-Cuff passed the panel of ISO 10993 biocompatibility, corrosion, nickel leaching, and fatigue cycling durability tests. It was also found to be MRI compatible at both the 1.5 and 3.0 Tesla levels, allowing patients to safely go through standard MRI diagnoses, if needed. An Investigational Device Exemption (IDE) has been granted by the Food and Drug Administration (FDA) for a clinical feasibility study. This proposal has the following aims. Specific Aim 1: Manufacture Ω-Cuff in 5 sizes for the clinical study. Per FDA mandate, we will manufacture 5 sizes (20 each) for the clinical study. Specific Aim 2: Conduct human clinical early feasibility study with 8 patients. The study is an observational, prospective, non- randomized, open label, feasibility study of patients receiving the Ω-Cuff device, to evaluate the safety of Ω- Cuff and its ability to reduce the GERD symptoms in augmenting the function of the LES. Specific Aim 3: Prepare report and document for an IDE amendment to expand into a pivotal study. The intent of this clinical feasibility study is to establish a basis for expanding into a pivotal study to complete the clinical validation process. Commercialization will commence after completion of the pivotal clinical study and receiving approval from the FDA to market Ω-Cuff in Phase III.