Israel-based EarlySense intends to follow the US launch of its EverOn inpatient supervision system with a partnership-based EU introduction in early 2011. Speaking at Medica 2010, EarlySense senior executives told IBI principal analyst Ashley Yeo that the device fulfils hospitals' needs for improved clinical and economic outcomes, saving ICU time – and lives
Half of the 2.5 million annual US cases of inpatients being harmed unnecessarily (including 180,000 deaths resulting from medical errors) are preventable. But with nursing staff stretched thinly, patients who have been returned to the wards after surgery are not always monitored as they should be.
Nurses are sometimes only able to give sporadic attention to patients, visiting every few hours, and are thus "blinded" to incidents that may occur (falling out of bed, developing ulcers, deteriorating cardiac conditions or administration of the wrong medication) – and thus sometimes get to the patient too late.
This is compounded by the fact that the general wards, representing 80% of the inpatient population, are receiving more acutely ill patients with no increase in staffing. Indeed, Vanderbilt University School of Nursing professor Peter Buerhaus believes the US will be short of half a million nurses by 2025.
To improve the supervision of general ward inpatients, Ramat Gan, Israel-based EarlySense has spent the last six years developing a sensor-based system that alerts nurses to changes in the patient's vital signs and motion parameters. This enables them to identify when to intervene, without false alarms.
Speaking to Clinica at the bustling Israeli medtech pavilion at Medica 2010, Avner Haleprin, CEO, and Amir Cohn, vice-president of operations, said the device will compete in a one million-patient market in the EU. The market is of a similar size in the US, where the product was launched at the end of November 2010.
The EverOn is an ultra-sensitive vibration sensing pad which is not connected to the patient with cuffs or leads, and allows unrestricted freedom of movement. It is placed beneath the mattress in the top half of the bed. The pad monitors vibrations from three sources: hand and leg movements, indicating if the patient has moved out of the bed; the pattern of chest and abdomen movements to measure respiration; and the "cardio-ballistic" effect – the mechanical effect of the patient's heartbeat – to measure the patient's pulse and heart rate.
The pad is plugged into a display unit at the bedside and displays data automatically when the patient gets into the bed. The information is summarised on large, wall-mounted displays that can be located in central locations in the hospital, colour-coded for the nurses on duty. The alerts are also sent directly to the nurse's mobile phone or pager.
The system, which self-calibrates, covers practically the whole bed, and can stay in place for a year, after which the sensing elements begin to lose sensitivity (they are easily replaced). So far, EarlySense has accumulated one million patient hours of information on a database.
"The early warning means that potentially serious incidents are contained with timely intervention. Being able to identify any problems reduces the impact," said Mr Halperin. He explained that the company has so far raised $31m, which has covered development and marketing expenses.
"The current EverOn is the third-generation product. It is getting high clinician satisfaction scores due to positive clinical impact and the economic benefits derived," he said. The system costs $7,500 per bed, including all central displays, software and nurse phone integration.
Monitoring technologies are not reimbursed in the US, but that is not necessarily a major drawback to use, he said. "The reduced level of adverse incidents generates a business case in its own right." The "soft" benefits – patient satisfaction and sense of security – are also compelling.
The company intends to target nursing homes as a market for the device, and will also offer it for home use in future. Home use was, in fact, its first intended application, but the company realised during product development that it should initially target hospital use, Mr Cohn said.
EarlySense believes that its US- and EU-patented product will, in time, become a firm part of the patient care environment. The company and its technology has attracted interest from other corporate entities, but that is viewed as of secondary importance for the time being.
"Right now we are focused on bringing the product to market," said Mr Halperin. In the US, EarlySense is going direct, while in Europe it is searching for distribution partners.
