Gastro-oesophageal Reflux Disease (GERD) is a digestive disorder associated with symptoms such as heartburn and regurgitation, and reflux of normal gastric content like gastric acid and digestive enzymes. GERD is caused by a loss of integrity of the gastro-oesophageal barrier known as the 'lower oesophageal sphincter' (LES). Dysfunction and loosening of the LES results in the painful reflux of gastric acid. The most common drug used for GERD treatment are Proton Pump Inhibitors (PPI) which only mask the symptoms and increase the risk of premature death. Alternative GERD treatments like Stretta®, Esophyx®, Lynx®, and Endostim® have failed to prove long-term efficacy, the gold standard surgical treatment remains invasive surgery (Gastric Nissen fundoplication), which is expensive, requires anaesthesia and in-patient care, and has a fairly high failure rate. GERD is one of the most common gastroenterological diseases in the European Union and globally, with an estimated 20 Million daily sufferers in the E.U. and 400 million globally. AscentX Medical has developed G125, a novel, least-invasive and cost-efficient out-patient procedure to cure GERD. The treatment will allow gastroenterologists- for the first time- to cure their own GERD patients without the need for referral to a surgeon for more invasive procedures. G125 treatment is based on permanent injectable soft tissue augmentation (‘bulking’) that restores the physiological barrier of LES muscle sphincter by creating a ‘mucosal plug’ and stimulating growth of autologous human collagen. The company aims to scale up the production to 20,000 units for G125 for commercial use and conduct clinical trials to validate the safety and efficacy of the solution.
