G125 SIGNED

Project "G125" data sheet

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 Partnership

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 Project objective

Gastroesophageal 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-esophageal barrier known as the 'lower esophageal sphincter' (LES). This condition is one of the most common gastroenterological diagnosis in the European Union, with an estimated 15-20 Million daily sufferers. GERD today is typically treated with medications such as proton pump inhibitors (PPIs). Unfortunately, these anti-acid medications only ‘mask’ GERD symptoms, cause severe side-effects long-term, and about 20% of patients are non-responders. Importantly, they do not treat/cure the underlying root cause of acid reflux. For people who have severe GERD and do not respond to medication, invasive surgical intervention remains the only option. G125 is the least invasive outpatient treatment for Gastroesophageal Reflux Disease (GERD). It is a permanent injectable bulking agent for the endoscopic treatment which enables cell growth in the Lower Esophagal Sphincter (LES), thereby providing long term cure for the debilitating symptoms of GERD. G125 uses a tissue-friendly (biocompatible) microspheres made of Polymethylmethcrylate (PMMA) suspended in bovine collagen and an Elongated Flexible Syringe (EFS) which consists of an elongated catheter and a transition bore needle. The PMMA microspheres provide a permanent scaffold for stimulated fibro-vascular tissue ingrowth in the affected area. During the phase 1 project, a go-to-market strategy and a supply chain will be established, as well as further development plan will be drafted. Within the overall innovation project AscentX Medical will refine the endoscopic injection procedure, perform a 12 month clinical trial with 60 patients followed by a scale up of the production to prepare for commercialization.