Semler Announces Clinical Study Published Using QuantaFlo® as an Aid for Diagnosis of Heart Dysfunction in the Primary Care Setting

Rhea-AI Summary

Semler Scientific (SMLR) announced a study published in the Journal of Preventive Medicine validating QuantaFlo's role in diagnosing heart dysfunction. The study revealed a significant correlation (p<0.01) between QuantaFlo measurements and cardiac echocardiography, the gold standard in heart failure diagnosis. QuantaFlo offers a quick, non-invasive screening method, potentially transforming heart dysfunction detection in primary care. With 6.2 million heart failure cases in the U.S. and associated costs exceeding $30 billion, the early detection capability may lead to improved patient outcomes. Semler aims to enhance healthcare effectiveness with innovative solutions.

Positive

• Published study shows significant correlation between QuantaFlo and echocardiography (p<0.01).
• QuantaFlo offers a low-cost, non-invasive screening method that can significantly improve early heart dysfunction diagnosis.
• Potential to capture a broader market with the introduction of QuantaFlo for HD as an upgrade or standalone product.

Negative

• None.

SANTA CLARA, Calif., March 1, 2023 /PRNewswire/ -- Semler Scientific, Inc. (Nasdaq: SMLR), a company that provides technology solutions to improve the clinical effectiveness and efficiency of healthcare providers (HCPs), today announced the publication of a study in the peer-reviewed Journal of Preventive Medicine with data supporting the use of QuantaFlo as an aid to measure hemodynamics related to heart dysfunction (HD). Notably, the study showed a statistically significant correlation (p<.01) between QuantaFlo HD and cardiac echocardiography (Echo), which was used as the gold standard for diagnosing heart failure.

The article, "Clinical Evaluation of Volume Plethysmography as an Aid for Diagnosis of Heart Failure in the Primary Care Setting,"¹ which was co-authored by individuals affiliated with Semler Scientific, may be accessed through this link: https://preventive-medicine.imedpub.com/clinical-evaluation-of-volume-plethysmography-as-an-aid-for-diagnosis-of-heart-failure-in-the-primary-care-setting.pdf.

"Health care providers now have a point-of-care, low-cost, accurate means for detecting potential heart dysfunction in the primary care setting before overt signs or symptoms present," said Doug Murphy-Chutorian, M.D., chief executive officer of Semler Scientific. "Early detection can lead to the opportunity to delay or prevent progression of the disease through well-established methods of preventive care." 

Semler's QuantaFlo for HD is a portable, easy-to-operate non-invasive test, which takes less than five minutes to perform and can be administered by a healthcare professional in a clinic or home setting, providing immediate results. It may be sold as an SAAS upgrade for current QuantaFlo for PAD customers, or may be sold separately.

Echo and Heart Failure in the United States

• An estimated 6.2 million persons over age 20 have been diagnosed with heart failure.
• About one million new cases are diagnosed annually.
• Heart failure is a primary diagnosis in over one million hospitalizations annually.
• The total cost of heart failure care exceeds $30 billion annually.
• Mortality rates after hospitalization for heart failure are 31% within one year after diagnosis.

Heart disease may be "silent" and remain undiagnosed until a person experiences signs or symptoms of a myocardial infarction, heart failure or an arrhythmia. Multiple studies have shown that asymptomatic heart failure is much more common than symptomatic heart failure, but often unsuspected by the HCP. The most common way to diagnose heart failure is with Echo, requiring a referral to a cardiologist and a cardiovascular technician. In contrast, QuantaFlo HD may offer the ability to perform an inexpensive, early screening program for all patients at risk of heart failure, and to refer for Echo, as needed. The goal is to enable HCPs to more effectively encourage patients to adopt healthier lifestyles and to optimize proven guideline-directed medical therapies earlier, with the potential of improving long-term health outcomes.

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) and heart dysfunction (HD). QuantaFlo is used by Semler Scientific's customers to more comprehensively evaluate their patients for risk of mortality and major adverse cardiovascular events (MACE), associated with a positive QuantaFlo test. Semler Scientific has an agreement with Mellitus Health, Inc. (Mellitus) 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 it made investments in Mellitus, in NeuroDiagnostics Inc., a privately held company doing business as SYNAPS Dx, whose product, Discern™, is a test for early Alzheimer's disease, as well as Monarch Medical Technologies LLC, a privately held company whose product EndoTool™ offers a technology-enabled approach to inpatient glycemic management. 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 use of QuantaFlo as an aid for diagnosis of heart dysfunction, the benefits of early detection, early screening with QuantaFlo and impact on HCP and patient care, among others. Such forward-looking statements are subject to a number of risks and uncertainties that could cause forward looking statements to differ materially from those discussed here, such as whether or not QuantaFlo can successfully aid in the diagnosis of heart dysfunction and whether or not Semler Scientific can expand this offering to its existing customer base, along with those risk factors 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.

INVESTOR CONTACT:
Susan A. Noonan
S.A. Noonan Communications
susan@sanoonan.com
917 513 5303

1 Howell SC, Master RC (2023) Clinical Evaluation of Volume Plethysmography as an Aid for Diagnosis of Heart Failure in the Primary Care Setting. J Prev Med Vol.8 No.2: 184.

 

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SOURCE Semler Scientific, Inc.

FAQ

What is the significance of the QuantaFlo study published on March 1, 2023?

The study demonstrates a statistically significant correlation between QuantaFlo measurements and echocardiography, suggesting its utility in diagnosing heart dysfunction.

How does QuantaFlo improve diagnosis of heart dysfunction?

QuantaFlo provides a fast, non-invasive point-of-care test that can detect potential heart dysfunction before symptoms appear.

What are the implications of the QuantaFlo study for healthcare providers?

By facilitating early detection of heart dysfunction, QuantaFlo may enable healthcare providers to implement preventive care strategies, potentially reducing hospitalizations.

What market opportunity does Semler Scientific foresee with QuantaFlo?

With millions affected by heart failure annually, Semler anticipates substantial demand for QuantaFlo as a cost-effective screening tool in primary care.