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 has completed the
design of EndoCheck based on the analysis of samples received from
The University of Oxford in October. Data show EndoCheck to be a
high-performing blood test for localized endometriosis, including
ovarian endometriosis masses known as endometrioma. The Company is
collaborating with The University of Oxford on an abstract for
presentation and a manuscript for publication to support a
commercial launch in 2024. Independent verification of the
EndoCheck test for endometriomas, the next step in its development,
will begin shortly with data to be provided by The Dana Farber
Cancer Institute.
Endometrioma is a localized form of endometriosis that has
formed an ovarian mass. It is one of the most common types of
endometriosis. All endometriosis, including endometriomas, are
currently diagnosed through invasive laparoscopic surgery.
Performance of the EndoCheck test is expected to be sufficient to
offer a non-invasive clinical alternative to laparoscopic surgery
for endometriomas.
Up to 44%1 of patients with endometriosis of all stages are
found to have an endometrioma. With over 6 million women in the
U.S. estimated to be suffering from endometriosis, the addressable
market for the non-invasive test for identifying endometrioma is
estimated by the Company to be up to 2.5 million. The Company plans
to expand the intended use of the test in other forms of
endometriosis through additional research to further increase
EndoCheck’s addressable market.
“EndoCheck builds upon our unique know-how with AI machine
learning and knowledge of gynecologic disease, which are the
hallmark of our tests,” said Nicole Sandford, President, and CEO of
Aspira. “This is an incredibly complex disease, and the development
of the test has taken longer than expected. Nonetheless, we are
excited to have a test with such a clear signal - a truly
first-of-its kind accomplishment. Our next priority is to ensure a
successful commercial launch through a thoughtful introduction of
EndoCheck into the payor and provider markets in 2024. We are
working with our Clinical Advisory Board and our network of
academic and clinical collaborators to do just that.”
EndoCheck was developed on an FDA-cleared platform in the
Company’s CLIA laboratory, which will support a rapid launch as a
Lab Developed Test upon completion of the remaining validation
steps, assessment of the commercial application, and publication of
a peer reviewed manuscript.
In addition to EndoCheck, the Company has continued its progress
with the development of EndoMDx which incorporates miRNA, proteins,
and clinical characteristics to identify all types and locations of
endometriosis. Aspira is developing EndoMDx through a sponsored
research agreement with a consortium of world-class academic and
research institutions led by The Dana Farber Cancer Institute.
Platform migration and test validation of a proprietary EndoMDx
signature, delivered earlier this year, is underway. Aspira
believes samples from The Dana Farber Cancer Institute, its
existing endometriosis biobank, and the ongoing EndoCheck Clinical
Study will be sufficient to complete design and development of
EndoMDx in 2024.
Dr. Jody Berry, Chief Scientific Officer of Aspira, noted, “Our
knowledge and understanding of endometriosis grows every day. With
its complex spectrum of phenotypes, the successful development of
noninvasive methods to identify all presentations of endometriosis
will require a portfolio approach. We are excited that data show
our EndoCheck test to be highly effective in identifying localized
ovarian endometriosis and expect development for a broader
indication to accelerate now that the design of a potentially high
performing EndoMDx signature is complete.”
Ms. Sandford concluded, “Our progress has generated renewed
interest in our approach and scientific achievements. We are
accelerating our conversations with potential partners in the
industry that can further our strategic options and drive long-term
shareholder value. I am proud of the advancements we have made and
look forward to sharing more details with investors at an Analyst
Day event in January 2024.”
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 rule out ovarian cancer malignancy and
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 StatementsThis 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
SullivanDirector of Corporate CommunicationsAspira Women’s
HealthJsullivan@aspirawh.com
1 Engin Oral, Berfu Demir,
and Umit Inceboz; “Endometriosis and
Ovarian Reserve”; Sage Journals Women’s Health Special Report;
Volume 11, Issue 5; September 2015.
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