The competition is heating up to corner the market on personalized care for 20 million asthmatics in the U.S. with new technology that allows physicians to test fractional exhaled nitric oxide (FENO), a measurement for assessing asthma-related airway inflammation.
Earlier this month, Aerocrine (New Providence, New Jersey) received FDA 510(k) clearance of Niox Mino, a hand-held point-of-care device for the measurement of airway inflammation.
Now, Apieron (Menlo Park, California) reports its Insight eNO system also cleared for marketing. Both devices are intended to be used in a physician's office to provide instant readouts of a patient's inflammatory process and predict response to therapy.
"Inflammation is currently treated by inhaled corticosteroids," Rich Lotti, Apieron president/CEO, told Diagnostics & Imaging Week."Our Insight eNO is designed to measure the amount of exhaled nitric oxide in the breath. It's the primary biomarker for inflammation of the lungs. Physicians prescribing corticosteroids will want our device to help them decide to increase or decrease dosages."
The Insight eNO includes a small desktop monitor with a display, trend analysis capabilities and a user-friendly interface. The system uses disposable, single-use sensors to measure nitric oxide accurately and non-invasively.
When a patient breathes into Apieron's biosensor, nitric oxide from the breath binds with protein inside a gel-like matrix. An optical measurement of this binding gives nitric oxide values in less than a minute.
One big difference between the two companies' FENO measurement tools is price. Apieron's Insight eNO costs $7,495 with disposable breathing tube kits, used for each patient, costing $15 apiece. It's good for 18,000 test cycles without maintenance. Lotti estimates the device would be functional for up to four years. After that, Insight is returned to the company for servicing and sent back to the physician.
Niox Mino, which costs about $5,000, has capacity for 1,500 usages or three years of use.
Lotti said his company put a great deal of thought into hygiene when constructing the Insight eNO."On the Niox Mino device, you pick it up in your hands, inhale and exhale and hand it off," Lotti said."The feedback we got form nurses is that this is a hygiene violation ... the idea of patients picking it up and handing it off to other patients. Insight eNO has a disposable breathing tube for each patient."
Insight eNO also includes patient-specific smart cards to record and save their eNO data.
Lotti said his company will target sales efforts to the 3,000 allergists in the U.S. initially, but there are 80,000 physicians in the U.S. who prescribe asthma corticosteroids.
Apieron is a private, venture-backed company formed in early 2001 to develop the Insight eNO, its only product. Lotti said the company plans to manufacture the Insight eNO in house without a partner."But we expect to go out and raise more funds to increase our manufacturing capacity at some point," he said.
"We expect to start shipping our product during the first week of April," Lotti said.
Insight eNO is cleared for use in children over eight years of age and adults.
"We have another device in development for the pediatricians' office," Lotti said."It's the same technology but we'll focus on younger patients."
Within the next couple of years, Apieron will develop a home-use version of the Insight eNO.
"It's important to educate physicians and patients for first two years on how to use Insight and how to personalize therapy," Lotti said"Once we've established that, we believe that any patient with severe asthma will want this device at home. This is the glucometer for asthmatics."