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Accelerating market introduction of the first real-time diagnistic and monitoring device for upper gastrointestinal bleeding (UGIB)

Periodic Reporting for period 3 - PillSense (Accelerating market introduction of the first real-time diagnistic and monitoring device for upper gastrointestinal bleeding (UGIB))

Periodo di rendicontazione: 2021-01-01 al 2021-06-30

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.
The consortium has successfully progressed the PillSense project from a technical, regulatory, clinical, and commercial perspective. The team has filed new IP during 2019, 2020 and 2021 and will continue to add to its intellectual property portfolio. Having successfully built all the required capsules for testing and for clinical use units for Phase 1 and Phase 2 of the clinical trials and over 100 receivers built for the same purposes by SteriPack. The process to build the capsule has been developed and is now operational at a scalable level as evident from the capsules and receivers built for the clinical trials. EnteraSense presented findings at the largest Gastrointestinal conference in the world, Digestive Disease Week (DDW) is a significant milestone for the team and validates the scientific relevance of PillSense.

Significant testing has already been completed, additional testing requested by FDA has also been completed allowing for the submission to the FDA for device clearance. Other deliverables and milestones such as pre-clinical validation through a GLP in-vivo study have all been completed in 2020 despite the impacts of COVID-19 which has had significant impacts on our timelines due to the restricted access to clinical sites in Europe and the US. In Europe, the adoption of the new MDR and the transition of the Notified Bodies has altered the regulatory pathway requiring further clinical work to allow for application for the CE Mark which has also been submitted to BSI.

PillSense commercialisation planning has progressed significantly, having engaged with patients and clinicians over the last 2.5 years, validating the market opportunity for PillSense. It is very evident that this product provides a breakthrough approach in blood detection as there are currently no specific diagnostic devices for UGI bleeds on the market. Successful results from Phase 1 and Phase 2 validates this further. PillSense will have a major economic benefit due to a significant reduction in the healthcare cost to patients presenting with suspected UGI bleeds. Taking into consideration the current worldwide healthcare trends this technology is aligned with those trends, reducing admissions to hospitals, reducing the length of stay for patients, and providing the ability to monitor these patients in in an acute care setting.

EnteraSense have delivered a product that has now been tested in humans. Following clinical investigation planning, clinical protocol development and competent authority approvals the clinical sites, clinical staff training for product use and data collection and correlation to successfully complete the FIH (Phase 1) and Phase 2 studies totalling 40 patients. In addition, an EU Submission Dossier has been completed and ISO 13485 certification has been achieved.
Upper endoscopy, (EGD), the current standard of care for UGIB is a procedure that enables the gastroenterologist to examine the oesophagus, stomach, and duodenum. Traditional endoscopy is an effective approach for finding, diagnosing, and treating abnormalities in the upper GI tract, including bleeding, ulcers, dysphagia, and strictures. During the procedure, the endoscope is advanced through the mouth into the oesophagus, stomach and duodenum while the patients is unconscious or, more commonly, deep sedation. It is completed in theatre and enables physicians to view the tissue and therefore it can be used to evaluate the presence of the bleeding source and discriminate between past and active bleeds.

EnteraSense are developing PillSense to identify and monitor active upper gastrointestinal bleeding without the need for endoscopy. PillSense is a combination of an innovative photonic-based sensor, cutting edge low-power microelectronics, and in-body wireless communication system with advanced manufacturing process for overall miniaturisation.

Key USPs of GI-Detect include:
• Non-invasive
• Active bleeding detection
• Immediate diagnosis
• Differentiation between active/old bleed
• Works in stomach and upper GI tract
• No capital equipment required

Commercialisation of a swallow-able diagnostic device for real time detection and monitoring of UGIB market (total patients >2million, market value >€1billion) will significantly reduce the costs of healthcare systems and improve clinical outcomes.
PillSense Capsule & Receiver
EnteraSense Team 2020
PillSense Capsule