Using an unique and innovative technology known as peripheral arterial tone (PAT), Itamar Medical (TASE:ITMR) is detecting the functioning and health of arteries through a finger sensor for the diagnosis of sleep apnea and heart disease.
“Our technology is a non-invasive measurement of changes in a patient’s pulsatile arterial volume that provides a window to the cardiovascular system and autonomic nervous system,” CEO Gilad Glick says in an interview with BioTuesdays.com.
“The PAT signal is an important physiological marker providing, to the best of our knowledge, significant clinical information about the medical state and well-being of an individual beyond commonly used tools,” he adds.
Israel-based Itamar has developed two product lines from its technology: WatchPAT for the diagnosis of sleep apnea and EndoPAT for endothelial function assessment of cardiovascular risk. The technology is protected by 81 patents, with 21 pending.
“For many years, the company sold products into the research market as its business model. But two years ago, with more than 400 peer-reviewed publications to our credit, the commercialization focus was directed towards clinical use and that’s when I was hired,” Mr. Glick recalls.
WatchPAT and EndoPAT have regulatory clearances around the world and reimbursement in the U.S. and Japan. To date, Itamar has sold more than 6,500 WatchPATs and more than 1,500 EndoPATs. Sales in the second quarter this year were a quarterly record of $4.1-million, up 18% from a year ago.
Mr. Glick explains that sleep apnea for many years was diagnosed using polysomnography sleep studies performed in hospital sleep laboratories, where patients are hooked up to more than a dozen electrodes.
“WatchPAT represents the best that 21st century medicine and science have to offer for at-home testing,” he contends.
“Thanks to WatchPAT’s ease-of-use and automated data analysis, patients don’t have to wait to get a diagnosis,” he adds. When a WatchPAT is returned to the physician, a detailed sleep report is quickly generated, compared with a lengthy wait in most hospital-based settings, and treatment of sleep apnea can begin the same day.
According to Mr. Glick, about one-third of all testing for sleep apnea was done at home in 2013, with forecasts predicting home testing will dominate the market by 2016.
A diagnosis of sleep apnea qualifies patients to be reimbursed for treatment, including continuous positive airway pressure or a CPAP machine, which has become the gold standard in daily treatment. Oral appliances and surgery are also used to treat sleep apnea.
“Sleep apnea is no long a lifestyle issue defined solely by snoring and tiredness,” Mr. Glick points out. “Today, sleep apnea is a contributing cause of many disorders, including drug resistant hypertension, obesity, congestive heart failure, Type 2 diabetes, stroke and atrial fibrillation.”
He points to a study published in the July 2013 issue of the peer-reviewed Journal of the American College of Cardiology, where researchers concluded that managing sleep apnea may lower the risk of atrial fibrillation recurrence after catheter ablation to treat cardiovascular disease.
Earlier this year, Itamar revised its commercialization strategy, shifting its focus from primarily direct sales and marketing to distribution agreements with partners, along with additional marketing support from Itamar.
To market WatchPAT to cardiologists in the U.S. and Japan, the company signed distribution agreements with Medtronic and Philips, respectively. Medtronic currently owns about 20% of Itamar. Philips also is funding a study in Japan to further accelerate penetration and patient enrollment is underway.
“Cardiology is a potentially large, and currently poorly served market for sleep apnea assessment,” Mr. Glick says.
To market EndoPAT to hospitals and more than 100,000 general practitioners in Japan, the company also signed a distribution agreement with Nihon Kohden, a leading medical device maker and distributor.
Mr. Glick explains that the EndoPAT device is used in a 15-minute non-invasive assessment of arterial health through the assessment of endothelial function, or the inner lining of blood vessels, which regulates vasodilation and vasoconstriction.
The device uses a thimble-like sensor placed on a patient finger of each hand. A blood pressure cuff temporarily stops blood flow to the arm and when blood flow resumes, the device measure the arterial reaction and expansion.
“Unlike complex ultrasound-based tests, the EndoPAT device is unique in offering ease of use and accurate information that is not reliant on the competency of the testing staff and the doctor who interprets the results,” Mr. Glick adds.
Citing the approved insurance reimbursement scheme for the test in Japan, the extensive ongoing academic and research activity there, and the inclusion of the EndoPAT test in the Japanese guidelines for assessing vascular function, he predicts significant potential in the deal with Nihon.
In the U.S., Mr. Glick says cardiologists at leading heart institutes, hospitals and medical centers are using EndoPAT.
“Our goal is to have EndoPAT testing adopted for all cardiac patients, since the test is affordable and easily performed in a cardiologist’s office, and also used to follow up patients and reduce hospital readmissions in order to improve patient outcomes,” he adds.
On the R&D front, Itamar is targeting new applications for the PAT signal, using its two product lines. “The autonomic nervous system is associated with many disease states and this is where our R&D effort is focused,” Mr. Glick notes.
“These are our near-term milestones as well as executing on the three distribution agreements we have signed this year.”