Gastrointestinal bleeding is a very common emergency condition, accounting for 7-8% of acute medical admissions and a mortality rate of up to 10%. Upper gastrointestinal bleeding (UGIB) is defined as bleeding from oesophagus, stomach, or duodenum. Peptic ulcers are the most common cause of Upper Gastrointestinal Bleeding. Acute gastrointestinal bleeding usually appears as hematemesis and melena. Acute gastrointestinal bleeding is a potentially life-threatening condition that remains a common cause of hospital admission.
Currently diagnosis is achieved by monitoring numerous clinical factors including patient history, physical examination, and laboratory tests, however this information is not sufficiently predictive, and a full endoscopic examination is required as a conclusive means of diagnosis. Endoscopy offers an image of the GI tract. Every patient with a suspected bleed needs to undergo endoscopy. Endoscopy requires an operating suite, a trained clinical team and pre-operative patient preparation therefore not always promptly available, is expensive and invasive and it exposes patients to a considerable degree of risk and stress.
Prompt diagnosis of UGIB and subsequent early treatment delivers better outcomes for the patient. Mortality rates for upper gastrointestinal bleeding range from 2% to 15% and increase in the elderly. Mortality is particularly high (20-30%) in patients who develop re-bleeding after admission to hospital. This group includes patients with UGIB that undergo unsuccessful treatment. In this group of patients, mortality rate can go up to 40%. Currently diagnosis including endoscopy is not always promptly available. In addition, at least 25% of the patients that undergo an endoscopy do not need to have that procedure.
PillSense is based on a disruptive technology which enables real-time detection of GI bleeding and subsequent monitoring. The overall system consists of a disposable pill-shape capsule and a reusable external receiver. For a fast and immediate diagnosis, the capsule is ingested, and it will send real-time information to the receiver enabling prompt diagnosis, early treatment and better patient outcomes. PillSense will remove the need for the unnecessary endoscopy, which potentially leads to savings to healthcare systems.
The objective for EnteraSense is to bring a solution to the healthcare market that improves patients’ outcomes, provides more efficient use of clinical time and generates significant savings in the healthcare system. In essence, the PillSense System is intended to accelerate care for those patients in whom blood in the stomach is detected, but never replace standard of care. In all cases, standard of care would continue to be followed; the PillSense System augments the timing of standard of care.
Regulatory filings have been completed in the United States and are ongoing in Europe to enable commercialisation of the product. The team are executing a commercialisation strategy that will enable a product launch plan for market entry, training and engagement with KOLs in target markets to deliver first sales.
