A New Endoscopic Treatment For Gerd
Fig. 3. LES location (L), PMMA microspheres (Top C), complete collagen encapsulation at 1 mo. (Bottom C), standard gastroscope (Top R), proprietary G125 injection device (Bottom R).
Based on our unique expertise in injectable soft tissue augmentation, we have developed and pre-clinically tested our novel, CLASS III MEDICAL DEVICES(2,3) to permanently augment and strengthen internal sphincter muscles via an easy-to-perform outpatient procedure. Our first product candidate G125 is a permanent injectable 'bulking agent' to endoscopically cure GERD by restoring the lower esophageal sphincter (LES) pressure. Our proprietary technology consists of absolutely uniform, round and smooth polymethyl- methacrylate (PMMA) microspheres that are precisely 125 microns in size, evenly suspended in a proprietary collagen carrier and pre-filled into syringes. Our microspheres meet strictest quality requirements set forth by the FDA.
These unique microspheres provide a 'stimulus' for autologous collagen deposition and a matrix for encapsulation with host collagen, creating a permanent 'mucosal plug'. After complete absorption of the bovine carrier collagen within one month, the newly formed host collagen represents approximtely 80% of the permanent tissue 'bulk'. Due to the viscosity of the collagen carrier, as well as their size, the microspheres cannot migrate nor be absorbed by the body and will permanently remain at the injection site. Within one month, each PMMA microsphere is encapsulated individually and anchored within host fibro-vascular tissue, further preventing dislocation or migration (Fig. 2). Thus the resulting new tissue formation is to be considered a permanent 'living implant', which is completely vascularized and shielded from infection, erosion and 'tissue sloughing', which have previously been observed with Enteryx®- the first and only FDA approved esophageal bulking agent to date (product discontinued by Boston Scientific in 2006).