Item 8.01 Other Information
Semler Scientific, Inc., or Semler, will seek a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded use of QuantaFlo® following correspondence with the FDA.
The new 510(k) is intended to enable expanded labeling for QuantaFlo® as an aid in the diagnosis of other cardiovascular diseases in addition to peripheral artery disease, or PAD.
Semler will continue to market and sell QuantaFlo® as an aid in the diagnosis of PAD, which is responsible for over 99% of its historical revenue to date. The roll-out of QuantaFlo® as aid in the diagnosis of other cardiovascular diseases is subject to FDA clearance of the new 510(k) clearance.
Forward-Looking Statements
This current report 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 and adoption of QuantaFlo® by existing and new customers, and seeking a new 510(k) clearance for QuantaFlo® with expanded indications for use, 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 seeking a 510(k) clearance from the FDA, risks associated with previously marketing QuantaFlo® with provocative functional maneuvers in reliance on letters to file, as well as those risk factors affecting Semler’s business that are detailed in Semler’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 current report 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 report and Semler assumes no obligation to update or revise these statements unless otherwise required by law.