Aspira Women’s Health Announces National Payer Coverage for OvaWatch
2023年3月3日 - 10:00PM
Aspira Women’s Health Inc. (Nasdaq: AWH), a bio-analytical based
women’s health company focused on gynecologic disease, today
announced that one of the nation’s top national health insurance
companies with over 80 million lives worldwide has agreed to extend
coverage to OvaWatchSM, Aspira’s new ovarian cancer test launched
by the Company in December 2022. The plan has covered the Ova1Plus®
test for its members for the past several years and this coverage
decision ensures OvaWatch will be provided on an in-network basis
for the plan’s members minimizing their out of pocket expenses. The
coverage decision was based on the latest published evidence
demonstrating the clinical validation of OvaWatch.
“We are very pleased to see one of the largest and most
progressive health plans in the country quickly recognize the value
that OvaWatch brings to patients and clinicians in better managing
ovarian cancer risk, and offer it to their members on an in-network
basis,” said Nicole Sandford, President and CEO of Aspira. “This
coverage decision further validates the important role our OvaSuite
product portfolio plays in the clinical management of women with
adnexal masses.”
About OvaWatchOvaWatch is a non-invasive,
multivariate index assay intended for use in the initial clinical
assessment of ovarian cancer risk in women with benign or
indeterminate adnexal masses. With a negative predictive value
(NPV) of 99%, OvaWatch allows physicians to confidently rule out
ovarian cancer malignancy and choose the right treatment for the
right patient at the right time.
Utilizing a clinically-validated, proprietary algorithm that
incorporates seven serum biomarkers and patient features such as
age and menopause status, OvaWatch provides a personalized risk
assessment score and corresponding negative predictive value. A
lower risk score indicates a low probability of malignancy,
providing additional confidence in a clinician’s plan to manage and
monitor. A higher score does not indicate the presence of cancer;
rather, it may guide the clinician to consider additional clinical
assessment, specialist consultation or surgery.
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.
Ova1Plus® combines our FDA-cleared products, Ova1® and
OVERA®, to detect risk of ovarian malignancy in women with adnexal
masses planned for surgery. EndoCheck™, 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 StatementsThis
press release contains forward-looking statements, as defined in
the Private Securities Litigation Reform Act of 1995, including
statements regarding the potential effects of widespread use of
OvaWatch and the availability of OvaWatch in New York.
Forward-looking statements involve a number of risks and
uncertainties. 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.
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” in Aspira’s Annual Report on Form 10-K for the year
ended December 31, 2021, as supplemented by the section entitled
“Risk Factors” in Aspira’s Quarterly Report on Form 10-Q for the
quarter ended September 30, 2022. These risks include, but are 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; impacts resulting from or
relating to the COVID-19 pandemic and actions taken to contain it;
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
environmental laws; 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; and
additional costs that may be required to make further improvements
to our laboratory operations. The events and circumstances
reflected in Aspira’s forward-looking statements may not be
achieved or occur, and actual results could differ materially from
those projected in the forward-looking statements. Aspira expressly
disclaims any obligation to update, amend or clarify any
forward-looking statements whether as a result of new information,
future events or otherwise, except as required by law.
Investor Relations
Contact:Monique Kosse Managing DirectorLifeSci Advisors,
LLCTel: 212-915-3820
Aspira Womans Health (NASDAQ:AWH)
過去 株価チャート
から 8 2024 まで 9 2024
Aspira Womans Health (NASDAQ:AWH)
過去 株価チャート
から 9 2023 まで 9 2024