Biomedicine

Optimizing the diagnosis of gastro-esophageal reflux disease for patients and clinicians

Principal Investigator:Wayne Shihwei Huang, MD, MPH

Abstract

Esophageal pH monitoring, the current gold standard for diagnosis of gastroesophageal reflux disease (GERD), is by use of either a catheter (wired) or a wireless pH probe. Done through the catheter, wired monitoring usually causes side effects, for example, nausea, extreme discomfort, and bleeding. The other wireless option is using a pH sensing capsule to measure pH levels in the esophagus and transmit readings by radio telecommunications to a receiver.

However, there are some disadvantages of incumbent wireless pH monitoring system. Problems that are frequently observed include failure to detect non-acid reflux, poor data reception, limited and non-intuitive control over symptoms and dining report (type, duration, severity, etc.). Despite its high cost, it is unable to correlate collected data with QoL in patients.

French IHU-Strasbourg and Show Chwan Memorial Hospital are jointly developing products overcoming the above disadvantages. We are confident that our products will soon be available in the global market with US FDA 510(k) approval and EU CE mark.

Fundraising Target:We will raise NT$30M Pre-A round for pursuing medical device approvals.
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Team Introduction

Show Chwan Healthcare System established IRCARD Taiwan in 2008 as Asia's first mi-nimally invasive surgery center for training. At present, more than 7,000 doctors from 60 countries have been trained, which is a place with high clinical resources. In addition, Show Chwan has integrated Taiwan's precision, mechanical, optical, machine tool and other industrial advantages and introduced capital investment to create the most complete one-stop minimally invasive surgery research and development platform.

Show Chwan Healthcare System and the French IHU-Strasbourg research team colla-borated to develop and improve esophageal pH testing and services. Developed technologies include (1) an improved physiological capsule that wirelessly communi-cates results to an external receiver. (2) Convenient receiver to receive the physiolog-ical data transmitted by the capsule (3) Dedicated user interface: Smart phone appli-cation software can enter data reported by the patient (4) Cloud computing service platform, this service receives patient data algorithms are used to generate reports that can be used by physicians.

Goals and Plan
Entry Barrier

The core competitiveness of this team lies in having important Key Opinion Leader (covering Europe, America and Taiwan) in the field of gastroenterology, hospital and clinical resources, software R & D capabilities and hardware manufacturing cost ad-vantage. The project team positions the FLUX product as "developed and recom-mended by the most authoritative laparoscopic surgeon in the world, verified as the most effective and efficient gastroesophageal countercurrent telecare product". Through the cooperation with thousands of doctors from the IRCAD Minimally Inva-sive Surgery Center's four training centers around the world (Europe, Asia, South America and Africa), in different countries and regions, combining local clinical expe-rience, develop local product marketing Strategy to penetrate the international mar-ket.

Market Scope

Gastroesophageal reflux disease (GERD) is a chronic gastrointestinal disease affecting the lower esophageal sphincter. The global GERD market forecasts that during the pe-riod from 2016 to 2020, the compound annual growth rate will be 2.85%. Over the past decade, the global prevalence of gastric acid reflux and related symptoms has increased by nearly 50%. The disease has a significant impact not only on patients' health and quality of life, but also on health care systems and the economy. In 2017, the global GERD drug and device market was valued at USD 5.658 billion and is expected to reach USD 6.220 billion by 2026, with a CAGR of 1.19% over the forecast period. The incidence of gastroesophageal reflux disease is rapidly increasing globally. Various studies have shown that almost everyone experiences an acid reflux in their lifetime.