Major Clinical Study Using Semler's QuantaFlo® for Medicare Advantage Beneficiaries, Demonstrates that National, In-Home Screening for Peripheral Artery Disease (PAD) is Feasible

SANTA CLARA, Calif., Dec. 14, 2022 /PRNewswire/ -- Semler Scientific, Inc. (Nasdaq: SMLR), a company that provides technology solutions to improve the clinical effectiveness and efficiency of healthcare providers, today announced that a study was published in the peer-reviewed AJPM Focus with data collected using the company's QuantaFlo® PAD test under real-world conditions, illustrating the benefits of PAD in-home screening. AJPM Focus is the official open access journal jointly launched this year by both The American College of Preventive Medicine and the Association for Prevention Teaching and Research. The article, titled "Peripheral Artery Disease Screening in the Community and 1-Year Mortality, Cardiovascular Events, and Adverse Limb Events,"¹ may be accessed through this link: https://www.sciencedirect.com/science/article/pii/S2773065422000141#sec0015.

The study analyzed screening tests using QuantaFlo® for Medicare Advantage beneficiaries aged ≥65 years participating in the Optum HouseCalls program in the U.S. between April 1, 2017 and February 1, 2019. Of the 192,500 patients tested in their homes, 27.7% had a positive result for PAD. One-year all-cause mortality, 1- and 2-year major adverse cardiovascular events (MACE), and major adverse limb events (MALE) in the PAD positive patients were all significantly increased versus those patients who screened negative for PAD (p <.001). Moreover, the severity of the test results was associated with worse outcomes.

This study provides evidence for the feasibility of a nationwide PAD-screening program with QuantaFlo® for individuals aged 65 years and older to assess previously undetected PAD burden, which can enable further stratification of all-cause mortality, MACE, and MALE risk. The authors stated, "Detecting previously undiagnosed peripheral artery disease is a way to risk stratify a population that would benefit from further cardiovascular risk management."

"We believe this study supports the use of QuantaFlo® for PAD by customers who conduct in-home testing, which may drive further adoption by existing and new customers," said Doug Murphy-Chutorian, M.D., chief executive officer of Semler Scientific. "Still to come is the publication of a separate study of QuantaFlo® used to aid in the diagnosis of another cardiovascular condition besides PAD. This manuscript is currently in final review by the publisher."

About Semler Scientific, Inc.:

Semler Scientific, Inc. is a company that provides technology solutions to improve the clinical effectiveness and efficiency of healthcare providers. Semler Scientific's mission is to develop, manufacture and market innovative products and services that assist its customers in evaluating and treating chronic diseases. Semler Scientific's patented and U.S. Food and Drug Administration (FDA) cleared product, QuantaFlo®, is a rapid point-of-care test that measures arterial blood flow in the extremities to aid in the diagnosis of cardiovascular diseases, such as peripheral arterial disease (PAD). QuantaFlo® is used by Semler Scientific's customers to evaluate their patients more comprehensively for risk of mortality and major adverse cardiovascular events (MACE), associated with a positive QuantaFlo® test. Semler Scientific has an agreement with Mellitus Health to exclusively market and distribute Insulin Insights™, an FDA cleared software product that recommends optimal insulin dosing for diabetic patients in the United States, including Puerto Rico, except for selected accounts, and has made an investment in this private software company. Semler Scientific has also invested in privately held Monarch Medical Technologies, whose product, EndoTool®, is used for glycemic management in inpatient settings and in SynapsDX, whose product, Discern™, is a test for early Alzheimer's disease. Semler Scientific continues to develop additional complementary innovative products in-house and seeks out other arrangements for additional products and services that it believes will bring value to its customers and to the company. Semler Scientific believes its current products and services, and any future products or services that it may offer, positions it to provide valuable information to its customer base, which in turn permits them to better guide patient care. Additional information about Semler Scientific 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 "goal," "may," "will," "intend," "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 express or implied statements regarding the feasibility of national PAD screening using QuantaFlo®, stratification of risks and impact on cardiovascular risk management, the increased use and adoption of QuantaFlo® by existing and new customers, and publication of the manuscript on the QuantaFlo® extension, among others. Such forward-looking statements are subject to a number of risks and uncertainties that could cause such forward-looking statements to differ materially from those discussed herein, such as risks associated with PAD screening and, as well as those risk factors affecting Semler Scientific's business that are detailed in Semler Scientific's filings with the Securities and Exchange Commission. These forward-looking statements 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 of this release and Semler Scientific assumes no obligation to update or revise these statements unless otherwise required by law.

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1. Smolderen KG, Ameli O, Chaisson CE, Heath K, Mena-Hurtado C. Peripheral Artery Disease Screening in the Community and 1-Year Mortality, Cardiovascular Events, and Adverse Limb Events, AJPM Focus
(2022), https://doi.org/10.1016/j.focus.2022.100016

SOURCE Semler Scientific, Inc.