December 19, 2023 08:00 ET
AUSTIN, Texas, Dec. 19, 2023 (GLOBE NEWSWIRE) — Aspira Women’s Health Inc. (“Aspira” or “the Company”) (Nasdaq: AWH), a bio-analytical based women’s health company focused on the development of gynecologic disease diagnostic tools, today announced that it will host a virtual R&D day featuring experts who will present the exciting progress of the company’s product pipeline on January 4, 2024 at 11:00 AM ET. To register, click here.
Upcoming R&D Day:
Aspira R&D Day: Updates on the Development of the Company's Ovarian Cancer and Endometriosis Tests
Date: January 4, 2024
Time: 11:00 AM ET
Location: Virtual
Registration: https://lifescievents.com/events/aspirawomenshealth/
The call will be hosted by Nicole Sandford, President and CEO. She will be joined by Jody Berry, PhD, Chief Scientific Officer for Aspira Women’s Health, and Kevin Elias, MD, Assistant Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School, Director of Gynecologic Oncology Laboratory at Brigham and Women's Hospital in Boston, Massachusetts, gynecologic oncologist, and surgeon-scientist at Dana-Farber Cancer Institute.
After a brief overview of the current treatment pathway for ovarian cancer and endometriosis, our panelists will provide an update on each of the company’s in-development products, including how each can close clinical gaps and improve health outcomes for women. Product updates will include upcoming milestones, pending publications, and future revenue potential for:
OvaWatchSM
The only commercially available ovarian cancer blood test for women diagnosed with an adnexal mass considered indeterminate or benign by initial clinical assessment. It will soon be available for longitudinal mass monitoring.
OvaMDx™
A promising new blood test that combines Aspira’s proprietary protein biomarker technology with miRNAs licensed from the Dana Farber Cancer Institute.
EndoCheckSM
The first protein biomarker test for the identification of ovarian endometriosis, including endometrioma.
EndoMDx™
A multimarker test that combines proteins, miRNA, and clinical data for the identification of endometriosis developed in collaboration with a consortium of academic and clinical partners led by the Dana Farber Cancer Institute.
A live question and answer session will follow the formal presentations.
About Jody Berry, PhD
Jody Berry, PhD is Chief Scientific Officer, SVP of Innovation and Product Development, at Aspira Women’s Health Inc. Dr. Berry joined Aspira from OraSure Technologies Inc., where he served as Chief Science Officer responsible for all innovation and product development including the breakthrough discovery of the first integrated swab test for COVID-19. Prior to that, Dr. Berry led immunochemistry research and development for Grifols Diagnostic Solutions, where he was responsible for the design of molecular and tissue culture laboratories and facilities for protein engineering, the development of a companion diagnostic for solid carcinomas using designer novel immune checkpoint inhibitor molecules and immunoassays for blood borne pathogens. He has also served in senior scientific and executive leadership roles for BD Biosciences and Cangene Corporation. Prior to beginning of his prestigious corporate career, he served as Head of Monoclonal Antibody and Bioforensics Response at the National Microbiology Laboratory of the Public Health Agency of Canada.
About Kevin Elias, MD
Kevin Elias, MD, is Assistant Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School, Director of Gynecologic Oncology Laboratory in the Division of Gynecologic Oncology at Brigham and Women's Hospital, and a gynecologic oncologist and surgeon-scientist at Dana-Farber Cancer Institute. Dr. Elias’s laboratory focuses on the prevention, diagnosis, and treatment of women with gynecologic cancers. His group includes a mixture of gynecologic oncology fellows, post-doctoral PhDs, technicians, and support staff. Their work is devoted to the early diagnosis of ovarian cancer, novel treatment approaches based on polymer chemistry, and in vivo models of gynecologic malignancies, including choriocarcinoma and ovarian cancer.
About Aspira Women’s Health Inc.
Aspira Women’s Health Inc. is transforming women’s gynecological health with the discovery, development, and commercialization of innovative testing options for women of all races and ethnicities, starting with ovarian cancer.
Our ovarian cancer risk assessment portfolio is marketed to healthcare providers as OvaSuiteSM, which includes OvaWatchSM, a non-invasive, blood-based test intended for use in the initial clinical assessment of ovarian cancer risk in women with benign or indeterminate adnexal masses for which surgical intervention may be either premature or unnecessary. With a negative predictive value (NPV) of 99%, OvaWatch allows physicians to confidently choose the appropriate clinical management for the right patient at the right time. Ova1Plus® combines our FDA-cleared products, Ova1® and Overa®, to detect risk of ovarian malignancy in women with adnexal masses planned for surgery.
EndoCheckSM, Aspira’s first-of-its-kind non-invasive diagnostic test for endometriosis, is currently in development. 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. Forward-looking statements generally are accompanied by words such as “will,” “plan,” “intend,” “potential,” “expect,” “could,” or the negative of these words and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the development of diagnostic tools, ability to offer patients and physicians a range of cost effective, non-invasive alternatives for diagnosing endometriosis, the verification of tests in other forms of endometriosis, validation and timing of the launch of EndoCheck, the impact on EndoCheck’s addressable market, and ability to drive long-term shareholder value. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management of Aspira and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Aspira. These forward-looking statements are subject to a number of risks and uncertainties, including but not limited to: our ability to continue as a going concern; our ability to comply with Nasdaq’s continued listing requirements; impacts resulting from potential changes to coverage of Ova1 through our Medicare Administrative Carrier for Ova1; anticipated use of capital and its effects; our ability to increase the volume of our product sales; failures by third-party payers to reimburse for our products and services or changes to reimbursement rates; our ability to continue developing existing technologies and to develop, protect and promote our proprietary technologies; plans to develop and perform laboratory developed tests; our ability to comply with Food and Drug Administration (“FDA”) regulations that relate to our products and to obtain any FDA clearance or approval required to develop and commercialize medical devices; our ability to develop and commercialize additional diagnostic products and achieve market acceptance with respect to these products; our ability to compete successfully; our ability to obtain any regulatory approval required for our future diagnostic products; or our suppliers’ ability to comply with FDA requirements for production, marketing and post-market monitoring of our products; our ability to maintain sufficient or acceptable supplies of immunoassay kits from our suppliers; in the event that we succeed in commercializing our products outside the United States, the political, economic and other conditions affecting other countries; changes in healthcare policy; our ability to comply with the additional laws and regulations that apply to us in connection with the operation of Aspira Labs; our ability to use our net operating loss carryforwards; our ability to use intellectual property; our ability to successfully defend our proprietary technology against third parties; our ability to obtain licenses in the event a third party successfully asserts proprietary rights; the liquidity and trading volume of our common stock; the concentration of ownership of our common stock; our ability to retain key employees; our ability to secure additional capital on acceptable terms to execute our business plan; business interruptions; the effectiveness and availability of our information systems; our ability to integrate and achieve anticipated results from any acquisitions or strategic alliances; future litigation against us, including infringement of intellectual property and product liability exposure; the impact of additional costs that may be required to make further improvements to our laboratory operations; and all other factors discussed in Aspira’s Annual Report on Form 10-K for the year ended December 31, 2022 and Aspira’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 under the heading “Risk Factors,” and other documents Aspira has filed, or will file, with the Securities and Exchange Commission. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Aspira presently does not know, or that Aspira currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Aspira’s expectations, plans, or forecasts of future events and views as of the date of this press release. Aspira anticipates that subsequent events and developments will cause its assessments to change. However, while Aspira may elect to update these forward-looking statements at some point in the future, Aspira specifically disclaims any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing Aspira’s assessments of any date after the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.
Investor Relations Contact:
Jamie Sullivan
Director of Corporate Communications
Aspira Women’s Health
[email protected]
