Updated 12:20 p.m., June 22, 2010.
Israeli medical device company EarlySense Ltd., which recently closed a $13 million fundraising round, has received Food and Drug Administration (FDA) clearance to sell its EverOn Touch patient-monitoring system in the United States.
The company based in Ramat Gan, Israel, also is pursuing European market clearance for the enhanced Touch system. The initial system already is approved for sale in the United States and Europe.
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EverOn is a patient-supervision system that goes underneath a hospital bed mattress. The device measures patients’ vital signs, such as heart and respiration rates, as well as movements to alert caregivers about their medical condition.
The Touch version of the product includes an online display that alerts medical staff about a patient’s motion level and verifies patient turns by nurses, the company said in a Business Wire release. Identifying low patient movement and then turning patients methodically can prevent pressure ulcers, one of the most costly patient safety risks in U.S. hospitals.
“Today’s FDA clearance news further validates our technology,” said Avner Halperin, EarlySense chief executive, in the release. “We have repeatedly heard from our partner hospitals that preventing pressure ulcers is a critical need due to the enormous burden pressure ulcers place on hospital budgets and the huge task of preventing them. The addition of pressure ulcer-prevention support capabilities to a system that already delivers vital-sign detection and bed-exit alerts further enhances the EverOn as a full contact-free patient safety suite for hospitalized patients.”
Clinical evaluations performed worldwide showed EverOn show significantly improved clinical and economic outcomes for hospitals using the system, the company said.
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“The EverOn Touch system incorporates feedback we have received from our clinical sites requesting a more convenient touch-screen interface, as well as more comprehensive patient-motion monitoring, especially as it relates to patients at risk of pressure ulcers and falls,” said Dalia Argaman, vice president of clinical and regulatory affairs at EarlySense, in the release. “The FDA clearance strengthens our belief that EverOn will make a positive impact on the future of clinical practice and improve patient care both at the hospital and in post acute-care settings.”
In early June, EarlySense raised $13 million from mostly Israeli investment firms to launch its improved monitoring system in the United States and Europe. Bridge Investment Fund in Cleveland, Ohio, also is an investor and participated in the recent fundraising round.
The company last year received a grant commitment from the Global Cardiovascular Innovation Center (GCIC) led by the Cleveland Clinic. At that time, EarlySense said it planned to establish a base of operations in the Cleveland area to develop the next version of its patient-monitoring device.
Though EarlySense has not yet opened a Cleveland office, which likely would employ sales and clinical trial support people, “hiring for that office is currently underway,” said Tom Sudow, business development director for the cardiovascular center and vice president of attraction for Team NEO. Sudow met with CEO Halperin in Tel Aviv, Israel, a week ago, as part of a healthcare delegation from Northeast Ohio.
Halperin “remains committed to opening up an office in Cleveland,” Sudow said. Opening the office is a condition for receiving the GCIC grant, which comes from a $60 million grant made to the center in 2006 by the Ohio Third Frontier project.