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 provided
interim commercial and operational updates for the second quarter
of 2024.
Product volume continued its sustained monthly gains, growing by
more than 26% in May 2024 compared to January 2024. Year-over-year
growth in monthly product volume per full-time sales representative
grew to 569 for the five months ended May 2024 compared to 484 for
the same period of 2023. This increase was achieved while also
shifting resources to cost-effective inside sales reps that
represent approximately 20% of the 19-person team as of May 2024.
Year-to-date OvaWatch® volume through the end of May 2024 is up by
more than 88% compared to the same period in 2023.
“We are excited to share highlights from across the
organization,” said Nicole Sandford, Aspira’s CEO. “The momentum is
truly undeniable. Product volume in May 2024 surpassed April
continuing our monthly growth we have experienced all year.
Importantly, we are reaching these new heights with a leaner, more
professional sales team. Sales volume per full-time representative
on a year-to-date basis continues to increase, proving that our
focus on our sales team while deepening relationships with larger
physician groups and channel partnerships is working. With our
highly qualified representatives in our territories and an expanded
inside sales capability, we expect to drive accelerated growth for
the rest of the year.”
Ms. Sandford continued, “OvaWatch sales growth is a major
leading indicator of our future growth. The addressable market for
OvaWatch, which is now available to assist in the initial and
ongoing assessment of malignancy risk for women with an adnexal
mass, is estimated to be between 2 and 4 million tests a year. This
is a more than 10-fold increase over the estimated Ova1Plus®
addressable market of approximately 200,000 tests per year. We
believe we are well-positioned to capture a significant share of
this larger market as a trusted provider of innovative gynecology
diagnostics, especially with the expansion of the test for mass
monitoring and the release of powerful new publications1,2 just a
few weeks ago.”
The Company’s expansion into the Philippines is on track for a
commercial launch of OvaWatch in the third quarter. Revenues from
this agreement are expected to generate higher margins compared to
margins achieved in the U.S. market as costs associated with
providing the test are absorbed by the Company’s laboratory partner
in the Philippines. Aspira will receive a fee-per-test for access
to its proprietary algorithm. Moreover, the Company’s inside sales
team will support physician adoption using third-party resources,
local to the Philippines, that are already trained and supporting
the U.S. sales team today.
On the reimbursement front, the Company today announced that it
has executed an OvaSuite contract with Anthem Plans of Connecticut,
New Hampshire, and Maine, adding over 2 million covered lives under
the umbrella agreement with Anthem. Aspira was nationally certified
by Anthem earlier this year and the Company expects to add up to 16
million covered lives over the next few quarters as additional
regions are added.
Additionally, the states of Maryland and Kentucky each expanded
their Medicaid coverage for OvaWatch adding the test to the fee
schedule at $897 per test. With the addition of these two states,
OvaSuite tests are now on the fee schedule in nine states, with
reviews in progress on several more.
Torsten Hombeck, Chief Financial Officer of Aspira added, “We
are glad to see our relationship with Anthem expand to a second
region within the Anthem family, bringing our total lives with
Anthem to 9 million. We anticipate adding more regions representing
an additional 16 million lives, including Ohio, Indiana, Missouri,
Wisconsin, and Kentucky in the coming months. We are optimistic
that other commercial payers will follow suit, given the strength
of our published data in the peer-reviewed journal Frontiers in
Medicine showing that OvaWatch can improve a physician’s ability to
predict malignancy by 431% and lower the number of unnecessary
surgeries by 62%1. The publication served as a tipping point in the
move by large physician groups to expand access to our OvaSuite of
products to their physicians.”
The Company anticipates providing a downward revision of the
2024 cash used in operations guidance during the second quarter
2024 earnings call.
About Aspira Women’s Health Inc.Aspira Women’s
Health Inc. is dedicated to the discovery, development, and
commercialization of noninvasive, AI-powered tests to aid in the
diagnosis of gynecologic diseases.
OvaWatch® and Ova1Plus® are offered to clinicians as OvaSuiteSM.
Together, they provide the only comprehensive portfolio of blood
tests to aid in the detection of ovarian cancer for the 1.2+
million American women diagnosed with an adnexal mass each year.
OvaWatch provides a negative predictive value of 99% and is used to
assess ovarian cancer risk for women where initial clinical
assessment indicates the mass is indeterminate or benign, and thus
surgery may be premature or unnecessary. Ova1Plus is a reflex
process of two FDA-cleared tests, Ova1® and Overa®, to assess the
risk of ovarian malignancy in women planned for
surgery.
Our in-development test pipeline is designed to expand our
ovarian cancer portfolio and addresses the tremendous need for
noninvasive diagnostics for endometriosis, a debilitating disease
that impacts millions of women worldwide. In ovarian cancer, our
OvaMDxSM risk assessment is designed to combine microRNA and
protein biomarkers with patient data to further enhance the
sensitivity and specificity of our current tests. In endometriosis,
EndoCheckSM is the first-ever noninvasive test designed to identify
endometriomas, one of the most commonly occurring forms of
endometriosis. The EndoMDxSM test is designed to combine microRNA
and protein biomarkers with patient data to identify all
endometriosis.
Forward-Looking StatementsThis press release
contains forward-looking statements, as defined in the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements involve a number of risks and uncertainties. Such
forward-looking statements include statements regarding, among
other things, the timing and completion of any products in the
pipeline development and other statements that are predictive in
nature. Actual results could differ materially from those discussed
due to known and unknown risks, uncertainties, and other factors.
These forward-looking statements generally can be identified by the
use of words such as “designed to,” “expect,” “plan,” “anticipate,”
“could,” “may,” “intend,” “will,” “continue,” “future,” other words
of similar meaning and the use of future dates. Forward-looking
statements in this press release and other factors that may cause
such differences include the satisfaction of customary closing
conditions related to the offering and the expected timing of the
closing of the offering. These and additional risks and
uncertainties are described more fully in the company’s filings
with the SEC, including those factors identified as “Risk Factors”
in our most recent Annual Report on Form 10-K, for the fiscal year
ended December 31, 2023, and subsequent Quarterly Reports on Form
10-Q. 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. Subsequent events
and developments may cause the Company’s assessments to change.
However, while Aspira may elect to update these forward-looking
statements at some point in the future, Aspira expressly 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: Torsten
Hombeck, Ph.D. Chief Financial Officer Aspira Women’s
Health Investors@aspirawh.com
1 Frontiers | Ovarian Cancer surgical consideration is markedly
improved by the neural network powered-MIA3G multivariate index
assay (frontiersin.org)
2 Neural network-derived multivariate index assay demonstrates
effective clinical performance in longitudinal monitoring of
ovarian cancer risk – Gynecologic Oncology
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