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 TestsDate:
January 4, 2024Time: 11:00 AM ETLocation: VirtualRegistration:
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:
OvaWatchSMThe 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.
EndoCheckSMThe 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
SullivanDirector of Corporate CommunicationsAspira Women’s
HealthJsullivan@aspirawh.com
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