Item 8.01 Other Events.



On September 18, 2020, AbbVie Inc. (“AbbVie”) provided Aspira Women’s Health Inc. (the “Company”) with certain serum samples collected and tested as part of AbbVie’s clinical trials.  The Company plans to use the samples in its upcoming EndoCheck™ product validation trial.  EndoCheck will be designed as a simple blood test to aid in the detection of endometriosis and, as such, will be less invasive than current detection methods, which require a surgical biopsy.  On September 18, 2020, AbbVie also provided the Company with additional data metrics, including patient demographics and endometriosis surgical pathology diagnoses, as well as other clinical metrics. 



This trial, if successful, will clinically validate the Company’s EndoCheck blood test. The test will initially be launched as a laboratory developed test, but the Company plans to design the trial and related studies to enable it to submit a marketing application to the U.S. Food and Drug Administration in the future if it chooses to do so.



This report contains forward-looking statements, as that term is defined in the Private Litigation Reform Act of 1995, that involve significant risks and uncertainties. All statements other than statements of historical facts contained in this report are forward-looking statements, including statements regarding the Company’s expectations about the use of the samples provided by AbbVie, the design of EndoCheck, the validation trial study and the potential effects of its success. Words such as “may,” “expects,” “intends,” “anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,” “potential,” “projects” and similar expressions are intended to identify forward-looking statements. The forward-looking statements speak only as of the date of this report and are subject to a number of risks, uncertainties and assumptions, including risks and uncertainties inherent in the Company’s business, as well as those described in the section entitled “Risk Factors” in the Company’s Form 10-K for the year ended December 31, 2019, as supplemented by the sections entitled “Risk Factors” in the Company’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020 and June 30, 2020, and in the Company’s other periodic filings with the Securities and Exchange Commission. The events and circumstances reflected in the Company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. The Company expressly disclaims any obligation to update, amend or clarify any forward-looking statements to reflect events, new information or circumstances occurring after the date of this report, except as required by law.