The ultimate goal of this project is to develop a simple product, Partial Cuff (PC), to treat gastroesophageal reflux disease (GERD or acid reflux). Of the 40 million U.S. GERD sufferers managing their symptoms by life- time medications, 5 million will require treatments due to failure of their prescriptive medications. The revelation of significant side effects from long term Proton Pump Inhibitors (PPIs) usage will drive the remaining 35 million on prescription or over the counter PPIs to receive treatment. GERD is the most expensive of all of the GI diseases, with an annual healthcare cost >$10 billion. Due to its severity, risks and physiological perturbations, fundoplication surgery treats <1% of patients. The large and growing number of GERD patients drove the development of many alternative procedures. However, with significant technical challenges and less than satisfactory clinical outcomes, none of them has been widely adopted. PC emulates the proven partial fundoplication but is significantly simpler, easier and safer. It is to be placed laparoscopically, simply and directly onto the esophagus avoiding the cumbersome lifting and wrapping of a segment of the stomach over the esophagus. PC works with body's natural physiology to minimize adverse events common to all other surgical treatments for GERD. PC is designed to improve the quality of life and to mitigate life-long dependence on medications for millions of GERD sufferers. This in turn will result in a substantial reduction in national healthcare costs. Phase I device feasibility goals were successfully met: functional devices were made and implanted over the LES in pigs. Its flexibility and widening with food passage were visualized in vivo through fluoroscopy. Pigs continued to behave and gained weight normally. A special device design feature was developed that allows material to pass easier toward the stomach and not in reverse, and it also eliminates the need for a special device deployment tool. For Phase II, we propose to first refine and finalize the device design and surgical implantation procedure before carrying out a one-year GLP animal study with 24 pigs. Once the device design is finalized and devices made, we will also perform other preclinical tests required by the FDA for an implant device. These tests include the ISO 10993 panel of biocompatibility tests for sterilized devices, fatigue cycling tests to simulate life-time function in patients, an ASTM F2129 metal corrosion test as well a nickel leaching test, all for characterizing the nitinol frame properties. We also propose to build the clinical research study protocol for PC and carry out discussions with the FDA. All these research data results and the clinical study protocol along with the quality system documentation and GMP processes will be in an information package necessary for FDA to grant an IDE clinical study to be carried out in Phase IIB. Commercialization will commence after completion of the clinical study and approval from the FDA to market PC in Phase III.
20 of the 40 million U.S. acid reflux sufferers are on prescription medication management, and 5 million of them will require additional or alternative remedies. In this Phase II SBIR, CT Resources plans to expand the successful research from Phase I of a simple laparoscopic surgical device to treat GERD. Based on the same principle as the proven partial fundoplication surgery, this substantially simpler, easier and safer device will benefit patients, surgeons and payers.
