Aspira Women’s Health Announces Publication of Paper Validating OvaWatch™ Algorithm in Detecting Ovarian Cancer

AUSTIN, TX, June 16, 2022 (GLOBE NEWSWIRE) — Aspira Woman Health Inc. (“Aspira”), a women’s health bioanalytical company focused on gynecological diseases, today announced the online publication of a paper validating its OvaWatch™ algorithm in the detection of ovarian cancer. in the June issue of JCO Clinical Cancer Informatics.

The document, titled:Analytical Validation of a Deep Neural Network Algorithm for Ovarian Cancer Detectiondemonstrates the potential of OvaWatch to accurately assess the risk of ovarian malignancy in patients with pelvic masses. Ovarian cancer is the deadliest gynecological cancer, with most cases diagnosed at an advanced stage. Early detection of ovarian cancer is essential to help reduce mortality; however, other non-invasive risk assessment measures currently on the market vary in their usefulness.

“There is a huge need for early detection and stratification of ovarian cancer, especially for women with adnexal masses. OvaWatch has been shown to help evaluate treatment strategies, addressing many of the limitations of current biomarker-based blood tests,” said Dr. Gerard Reilly, director of clinical research and innovation at Axia Women’s Health and one of the main authors of the article. “Wider use of this noninvasive test could help assess appropriate care strategies for patients with a pelvic mass.”

Nicole Sandford, CEO of Aspira Women’s Health, said, “We are very pleased to see the results of this study published in a reputable journal. Once launched, we believe our OvaWatch risk assessment will become a valuable tool to help physicians determine appropriate treatment strategies for each woman presenting with an adnexal mass, and its adoption has the potential to improve health outcomes for patients. women with ovarian cancer.

About Aspira for Women Health Inc.
Aspira Woman Health Inc. transforms women’s health through the discovery, development and commercialization of innovative testing options and bio-analytical solutions that help physicians assess risk, optimize patient care and improve outcomes gynecological health for women. Aspira Women’s Health is particularly focused on closing the ethnic disparity gap in ovarian cancer risk assessment and developing solutions for pelvic diseases such as pelvic mass risk assessment and l endometriosis. OVA1plus™ combines our FDA cleared products, OVA1® and OVERA®, to detect the risk of ovarian malignancy in women with adnexal masses. Aspira GenetiX™ testing offers targeted, comprehensive genetic testing options with a gynecological focus. With over 10 years of expertise in ovarian cancer risk assessment, Aspira Women’s Health strives to provide a portfolio of pelvic mass products throughout a patient’s lifetime through our research peak. The next generation of products in development include OvaWatch™ and EndoCheck™. To improve patient accessibility, Aspira Women’s Health recently launched its Aspira Synergy™ technology transfer platform to enable health systems, academics, regional labs and physician group labs to perform genetic testing and in-house specialists. Visit our website for more information at www.aspirawh.com.

Forward-looking statements
This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding projections or expectations regarding our future testing volumes, revenues, cost of revenues, operating expenses, research and development expenses, gross profit margin, cash flow, results of operations and financial condition; our plan to expand our business focus from ovarian cancer to the differential diagnosis of women with a range of gynecological diseases, including additional pelvic diseases such as endometriosis and monitoring for benign pelvic mass in addition to genetic risk assessment, including hereditary risk of breast and ovarian cancer carrier assessment and screening; our planned business strategy and our strategic business drivers and their anticipated effects, including partnerships such as those based on our Aspira Synergy product, as well as other strategies, collaboration and sample licensing; plans to expand our existing products OVA1, OVERA, OVA1plus, Aspira GenetiX and Aspira Synergy globally, and to launch and market our new products, OvaWatch (formerly OVASight), EndoCheck and OVAInherit; plans to develop new algorithms, molecular diagnostic tests, products and tools and otherwise expand our product offerings, including plans to develop a product using genetics, proteins and other modalities to assess risk to develop cancer when carrying a pathogenic variant associated with hereditary diseases of the breast and ovarian cancer that are difficult to detect by a diagnostic test; plans to establish payer coverage and secure contracts for Aspira GenetiX, OvaWatch, EndoCheck and OVAInherit separately and expand current coverage and secure contracts for OVA1; plans that would address clinical issues related to early detection of disease, response to treatment, monitoring of disease progression, prognosis, and other issues in the fields of oncology and health women ; the anticipated efficacy of our products, product development activities and product innovations, including our ability to improve sensitivity and specificity over traditional diagnostic biomarkers; expected competition in the markets in which we compete; plans regarding ASPiRA LABS, including plans to expand or consolidate the testing capabilities of ASPiRA LABS; expectations regarding continued future services provided by Quest Diagnostics Incorporated; plans to develop computer products and to develop and perform laboratory developed tests (“LDT”); Changes in FDA oversight of LDTs; plans to develop a race- or ethnic-specific pelvic mass risk assessment; expectations regarding existing and future collaborations and partnerships for our products, including plans to enter into decentralized agreements for our Aspira Synergy product; plans for future publications; expectations regarding potential collaborations with governments, legislative bodies and advocacy groups to improve awareness and drive policy to provide broader access to our tests; our ability to continue to comply with applicable government regulations, expectations regarding pending regulatory submissions and plans to obtain regulatory approvals for our testing within United States and internationally, as appropriate; our continued ability to develop and protect our intellectual property portfolio; anticipated liquidity, capital requirements, future losses and our ability to continue our business; expectations regarding the raising of capital and the amount of financing expected to be required to fund our planned operations; expectations regarding the results of our clinical research studies and our ability to enroll patients to participate in such studies; our ability to utilize our net operating loss carryforwards and expected future tax liabilities under WE federal and state income tax laws; the expected market adoption of our diagnostic tests, including OVA1, OVERA, OVA1plus, as well as our Aspira GenetiX and Aspira Synergy Platform; expectations regarding our ability to launch new products that we develop or license, co-market or acquire new products; expectations regarding the size of markets for our products; expectations regarding reimbursement for our products, and our ability to obtain such reimbursement, from third-party payers such as private insurance companies and government insurance plans; plans to use each of AbbVie Inc.’s serum samples and ObsEva SA plasma samples in EndoCheck product validation studies; provides with respect to EndoCheck whether or not the FDA designates it as a breakthrough device; planned target launch schedule for OvaWatch and Endocheck; expectations regarding compliance with federal and state laws and regulations relating to billing agreements conducted in coordination with laboratories; plans to advocate for legislation and professional society guidelines to expand access to our products and services; and expectations regarding the impacts resulting from or attributable to the COVID-19 pandemic and the measures taken to contain it. Forward-looking statements involve a number of risks and uncertainties. Words such as “may”, “expect”, “intend”, “anticipate”, “believe”, “estimate”, “plan”, “seek”, “could”, “should” , “continues”, “will”, “potential”, “projects” and similar expressions are intended to identify forward-looking statements. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those described in the section entitled “Risk Factors” of the annual report. from Aspira on Form 10-K for the year ended December 31, 2020as supplemented by the section titled “Risk Factors” in Aspira’s Quarterly Report on Form 10-Q for the Quarter Ended June 30, 2021. Events and circumstances reflected in Aspira’s forward-looking statements may not materialize or occur and actual results could differ materially from those projected in the forward-looking statements. Aspira expressly disclaims any obligation to update, modify or clarify any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Contact with Investor Relations:Ashley R. RobinsonLifeSci Advisors, LLC
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