Semler Announces FDA Clearance for Next Generation PAD Testing System

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Mar 19, 2015, 08:07 ET

PORTLAND, Ore., March 19, 2015 /PRNewswire/ -- Semler Scientific, Inc. (Nasdaq: SMLR), an emerging medical risk assessment company that develops, manufactures and markets patented products that assist healthcare providers in monitoring patients and evaluating chronic diseases, today announced receipt of 510(k) marketing clearance from the U.S. Food and Drug Administration for its next generation peripheral artery disease (PAD) testing system.

The next generation system features convenience and ease of use characteristics along with compatibility to electronic medical record systems for easy accessibility of data. The system was designed to fit the needs of Semler's growing customer base of insurance plans and integrated healthcare delivery networks. The clearance allows enhanced marketing labeling and messaging to describe the benefits of working with Semler's disease risk assessment tools.

The company expects to launch this next generation system later this year.

"It is our intention to make this Semler product the standard of care approach to diagnosing vascular disease," said Doug Murphy-Chutorian, M.D., chief executive officer of Semler. "We have incorporated product features that we believe broaden the appeal of this Semler system especially to healthcare insurance plans and integrated healthcare delivery systems interested in population health and wellness."

About PAD:

Peripheral artery disease (PAD) is a disease in which plaque or fatty deposits build up in the leg arteries limiting blood flow. Published studies have shown that persons with PAD are four times more likely to die of heart attack, and two-three times more likely to die of stroke, yet more than 50% of people with the disease are undiagnosed. Preventative healthcare like cessation of tobacco smoking and regular exercise may lower the risks associated with PAD.

About Semler Scientific, Inc.:

Semler Scientific, Inc. is an emerging medical risk-assessment company. Its mission is to develop, manufacture and market patented products that assist healthcare providers in monitoring patients and evaluating chronic diseases. Semler's first patented and U.S. Food and Drug Administration cleared product, is FloChec®. FloChec® is used in the office setting to allow providers to measure arterial blood flow in the extremities and is a useful tool for internists and primary care physicians for whom it was previously impractical to conduct blood flow measurements. Additional information about Semler can be found at www.semlerscientific.com.

Forward-Looking Statements

This press release contains "forward-looking" statements. Such statements can be identified by, among other things, the use of forward-looking language such as the words "may," "will," "expect," "anticipate," "estimate," "project," "would," "could" or words with similar meaning or the negatives of these terms or by the discussion of strategy or intentions. The forward-looking statements in this release include statements regarding the timing of the launch of the next generation system, the ability of the new features to broaden appeal of the product and make it the standard of care, and whether or not the new system will be compatible with electronic medical record systems and meet the needs of the customer base, among others. Such forward-looking statements are subject to a number of risks and uncertainties that could cause Semler Scientific's actual results to differ materially from those discussed here, such as whether or not insurance plans and other customers will continue to lease FloChec®, along with those detailed in Semler Scientific's SEC filings, and involve assumptions, estimates, and uncertainties that reflect current internal projections, expectations or beliefs. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. All forward looking statements contained in this press release are qualified in their entirety by these cautionary statements and the risk factors described above. Furthermore, all such statements are made as of the date this release and Semler Scientific assumes no obligation to update or revise these statements unless otherwise required by law.

SOURCE Semler Scientific, Inc.