Readying the commercialization of Omega device as an improved safe and efficacious treatment for drug-failed GERD patients

Project Summary/Abstract GERD is a chronic condition that impacts 784M people worldwide by decreasing quality of life and potentially leading to serious complications. For the estimated 157 million worldwide GERD patients whose drug managements are not working or are leading to serious side effects (drug-failed), the only option is surgery, where a partial or full fundoplication is the gold standard. This treatment, though, is morbid and difficult and is reserved as a last resort. Aplos Medical's solution, Omega PF (Ω PF), is a novel therapeutic strategy for drug- failed patients, and the only treatment that replicates the one-way valve function of the Lower Esophageal Sphincter, allowing food to pass easily while preventing stomach acid from entering the esophagus. Early clinical results show that the Ω PF device is simple, effective, and safe (SES), and the only treatment in 80+ years that has all these three SES elements. It is also the only treatment that recreates the natural sphincter's one-way valve. Ω PF resolves patients' GERD without adverse events. Its simple laparoscopic procedure allows easy adoption by all foregut surgeons worldwide, and not limited to a few experts. The success of this early clinical outcome warrants the start to fulfill the many other requirements besides the clinical study necessary to commercialize Ω PF. The goal of this SBIR CRP research is to perform commercialization activities to successfully bring Ω PF to market. These include accomplishing the following Aims: (Aim 1) Optimize Introducer Design to Accommodate Human Anatomy, (Aim 2) Develop Quality Management System (QMS), (Aim 3) Develop Pivotal, Regulatory, Reimbursement, and Pricing Strategy, and (Aim 4) Develop an Intellectual Property Strategy. Completion of these aims will place the company in a position to successfully manufacture devices for the pivotal trial, secure reimbursement, and build the foundation with Key Opinion Leaders to support the go-to-market strategy for Ω PF as the logical treatment option for drug-failed GERD patients.