A minimally invasive, outpatient treatment for Gastroesophageal Reflux Disease (GERD), resulting in permanent relief from both GERD symptoms and life-long drug dependency

Periodic Reporting for period 1 - G125 (A minimally invasive, outpatient treatment for Gastroesophageal Reflux Disease (GERD), resulting in permanent relief from both GERD symptoms and life-long drug dependency)

Berichtszeitraum: 2019-09-01 bis 2019-12-31

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.

During the pre-clinical feasibility assessment, the company reviewed in more detail the objectives of the G125 device and defined a sound development plan based on the remaining activities needed to fine-tune the G125 injection procedure for clinical testing. One key objectives for the development of G125 is to scale up GMP production through the Company’s external CMO (PrimaPharma), and validate the device by conducting pre-trial validation tests (e.g. sterility, shelf-life); another objective has been the draft of the G125 clinical trial protocol, including all patient consent and evaluation forms to be prepared for clinical data collection and E.U. regulatory approval submission (CE-mark).
During the feasibility assessment, AscentX analyzed the overall digestive disorder market and its sub-segments. From there, the Company explored recent and future trends in the market of drugs and medical devices to gain a better understanding of the future growth and market opportunities in which it could penetrate. AscentX will be targeting gastrointestinal disorder therapeutics and diagnostics which was valued at €45.7 billion in 2016. The company is aiming for a revenue of 36 million in 2024.

The expected outcome of the project is to successfully execute the clinical validation and demonstrate that the efficacy rate of the G125 solution. G125 procedure aims to substitute existing GERD treatment PPIs in the market which carries serious side effects and can cause death in the long run. G125 can cater to millions of GERD patients around the world and can become the new gold standard treatment for a fraction of the cost against the existing standard treatment for GERD

G125 injection device

G125 agent syringe

Periodic Reporting for period 1 - G125 (A minimally invasive, outpatient treatment for Gastroesophageal Reflux Disease (GERD), resulting in permanent relief from both GERD symptoms and life-long drug dependency)

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