Project description
Simple outpatient treatment for acid reflux disease
Gastroesophageal reflux disease is a disorder of the digestive system caused by defects in the lower oesophageal sphincter, resulting in heartburn, regurgitation, and reflux of gastric acid and digestive enzymes. Very common in the EU, this condition is currently treated with symptomatic medications, which do not address the underlying cause. This EU-funded project aims to introduce minimally invasive outpatient treatment for this disease using injectable bulking agent to support endoscopic remodelling of the sphincter for a long-term cure. The procedure will involve injection of biocompatible polymethylmethacrylate microspheres to provide a scaffold for fibrovascular tissue ingrowth in the affected area. The first phase of the project will establish market strategy as well as the draft for the development plan.
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.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques.
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugs
- medical and health sciencesclinical medicinesurgerysurgical procedures
- medical and health sciencesclinical medicineanaesthesiology
- natural sciencesbiological sciencesbiochemistrybiomoleculesproteinsenzymes
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Programme(s)
Funding Scheme
SME-1 - SME instrument phase 1Coordinator
E95EN LONDON
United Kingdom
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.