Apieron, Inc. Announces FDA Clearance of the Insight™ eNO System to Assist Physicians with Patient Asthma Management
Physician’s office system for measuring airway inflammation poised to transform asthma management for improved control.
MENLO PARK, CA, MARCH 17, 2008, Apieron, Inc. Apieron, Inc. (www.apieron.com) announced today that the Insight eNO system has received clearance to market by the U.S. Food and Drug Administration.
The Insight eNO system measures exhaled nitric oxide (eNO) which is a well established indicator of airway inflammation and asthma control. The Insight system is a highly accurate device, expressly designed for the physician’s office. It is non-invasive, safe, easy to use, and provides results in less than a minute. Apieron’s unique biosensor detects trace amounts of nitric oxide molecules in a single human breath utilizing a proprietary technology. Current methods and techniques used to diagnose, monitor and treat asthma are costly, time-consuming and cumbersome. Physician office measurement of eNO is a much awaited breakthrough in medical technology that provides physicians with a reliable tool to measure their patient’s respiratory inflammation better than ever before. Measurement of eNO has also been shown to optimize medication therapy and improve compliance among patients with asthma.
William Berger, MD, Clinical Professor of Pediatrics, University of California, Irvine, and Mission Viejo Medical Center, Mission Viejo, California, stated, “In clinical studies with the Apieron Insight eNO monitor, I found the ability to easily and accurately measure eNO in the physician’s office to be a major advancement in my care for patients with persistent asthma.”
It is estimated that more than 20 million people in the U.S. suffer from asthma, making it one of the most common and costly of all diseases. In fact, every day in America 40,000 people miss school or work due to asthma and 5,000 people go to the emergency room due to an asthma attack. One-quarter of all emergency room visits are asthma related and asthma is the most common chronic childhood disease.
“We are pleased to offer physicians and their patients a reliable, accurate and affordable asthma measurement and management device,” said Rich Lotti, President and CEO of Apieron, Inc., “We believe this product will improve the standard of care for patients with asthma enabling physicians to optimize medical therapy for each patient.
"The availability of simple to use, accurate, and economically feasible eNO measurement devices now enables physicians to intelligently assess and manage the key pathologic feature of asthma, airway inflammation", said Peter B. Boggs, M.D., Clinical Professor of Pediatrics and Medicine, LSU School of Medicine, Shreveport, Louisiana. "Prior to the availability to measure eNO, assessing and managing airway inflammation was, for all practical purposes, little more than a guess! The ability to measure eNO in the physician's office is "one giant step" in the care of adults and children with asthma."
The Insight eNO system includes a small desktop monitor with an easy-to-read display, trend analysis capabilities and a user-friendly interface. The system uses disposable, single-use sensors to measure nitric oxide accurately and non-invasively in less than a minute. Disposable, single-use breath tubes make it hygienic and convenient for the user to exhale into the device. Patient data can be stored and maintained in unique patient cards for trend analysis or downloaded to a printer for insurers’ and patients’ files.
About Apieron Inc.
Apieron Inc. is a private, venture-backed medical device company based in Menlo Park, CA that was formed in early 2001 to develop a simple-to-use, non-invasive monitor for the measurement of exhaled nitric oxide (eNO) for the management of asthma. The Apieron biosensor technology platform utilizes a patented platform technology that allows for the highly sensitive detection of selected analytes like eNO. Apieron is committed to collaborating with physicians and patients to develop innovative medical solutions to improve quality of life and standards of care.
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