Femasys Announces Notices of Intention to Grant for Two New European Patent Applications Covering Use of FemBloc Permanent Birth Control
30 1월 2025 - 10:30PM
Femasys Inc., (Nasdaq: FEMY), a leading biomedical innovator
addressing significant unmet needs in women's health worldwide,
with a broad portfolio of disruptive, accessible in-office
therapeutic and diagnostic products, announces the European Patent
Office (“EPO”) issued notices of Intention to Grant for two EU
Patent Applications, EPO Application Nos. 24170531.8 and
18751753.7, which will have anticipated expirations in 2039 and
2038, respectively. Femasys plans to pursue additional patent
applications to further strengthen its existing portfolio
protecting FemBloc® permanent birth control, along with its other
products, including FemaSeed®, FemVue®, FemCath® and FemCerv®.
“The allowance of all requested claims for the two components of
the non-surgical FemBloc permanent birth control marks a key
milestone in extending protection for this revolutionary
alternative to traditional surgical sterilization, which is costly,
inconvenient, and carries significant risks,” stated Kathy
Lee-Sepsick, Femasys’ CEO. “Expanding our patent protection and
coverage in Europe ahead of commercial availability brings us one
step closer to advancing Femasys' mission to deliver essential
technologies to women globally.”
About FemBlocFemBloc® is a
revolutionary first-of-its-kind non-surgical permanent birth
control, that involves a minimally invasive delivery system to
introduce a specially designed blended polymer into the fallopian
tubes, triggering a natural healing response that blocks the tubes
with tissue in-growth. Designed for women seeking safe, accessible,
and cost-effective permanent contraception, FemBloc avoids the
risks and inconvenience of surgical sterilization. Participants are
being enrolled in a pivotal clinical trial (NCT05977751) for U.S.
approval. Previous clinical trials (NCT04273594, NCT03433911, and
NCT03067272) have demonstrated FemBloc’s safety as a permanent
birth control option compared to surgical sterilization. Learn more
at www.FemBloc.com.
About FemasysFemasys, an Atlanta-based leading
biomedical innovator, develops and commercializes a portfolio of
patent-protected, minimally invasive women’s health solutions, all
manufactured in the U.S. Our innovative therapeutic and diagnostic
products have received global regulatory approvals and are being
commercialized in the U.S. and select countries. FemaSeed®
Intratubal Insemination, a groundbreaking infertility treatment
delivering sperm directly to the site of conception, is U.S.
FDA-cleared and approved in Europe and Canada. FemVue®, a companion
diagnostic for fallopian tube assessment via ultrasound, is U.S.
FDA-cleared with approvals in Europe, Canada and Japan. FemCerv®,
an endocervical tissue sampler for cervical cancer diagnosis, is
U.S. FDA-cleared with approvals in Europe and Canada. FemBloc®
permanent birth control, the Company’s late-stage product
candidate, is the first and only non-surgical, in-office, method
offering significant benefits over the costly, inconvenient,
risk-laden surgical alternative. The fourth pivotal clinical trial
(NCT05977751) is now enrolling participants for U.S. approval.
FemCath® and FemChec®, companion diagnostic products for FemBloc’s
ultrasound-based confirmation test, are U.S. FDA-cleared and
approved in Europe and Canada. Learn more at www.femasys.com, or
follow us on X, Facebook and LinkedIn.
Forward-Looking Statements This press
release contains forward-looking statements that are subject to
substantial risks and uncertainties. Forward-looking statements can
be identified by terms such as “may,” “will,” “should,” “expect,”
“plan,” “anticipate,” “could,” “pending,” “intend,” “believe,”
“suggests,” “potential,” “hope,” or “continue” or the negative of
these terms or other similar expressions, although not all
forward-looking statements contain these words. Forward-looking
statements are based on our current expectations and are subject to
inherent uncertainties, risks and assumptions, many of which are
beyond our control, difficult to predict and could cause actual
results to differ materially from what we expect. Further, certain
forward-looking statements are based on assumptions as to future
events that may not prove to be accurate. Factors that could
cause actual results to differ include, among others: our ability
to develop and advance our current product candidates and programs
into, and successfully initiate, enroll and complete, clinical
trials; the ability of our clinical trials to demonstrate safety
and effectiveness of our product candidates and other positive
results; estimates regarding the total addressable market for our
products and product candidates; our ability to commercialize our
products and product candidates, our ability to establish,
maintain, grow or increase sales and revenues, or the effect of
delays in commercializing our products, including FemaSeed; our
business model and strategic plans for our products, technologies
and business, including our implementation thereof; and those other
risks and uncertainties described in the section titled "Risk
Factors" in our Annual Report on Form 10-K for the year ended
December 31, 2023, and other reports as filed with the SEC.
Forward-looking statements contained in this press release are made
as of this date, and Femasys undertakes no duty to update such
information except as required under applicable law.
Contacts: Investors: IR@femasys.com
Media Contact: Media@femasys.com
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