Femasys Inc. Announces First Patient Treated in Pivotal Trial for FemaSeed
July 20 2021 - 8:31AM
Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on
transforming women's healthcare, today announced the initiation and
first patient treated in a pivotal trial evaluating FemaSeed, a
first in class, localized directional insemination product
candidate for infertility.
“For more than 20 years, current approaches to infertility
treatment have been limited during the initial stage of therapeutic
care, but with the advancement of FemaSeed, we believe a next
generation intrauterine procedure may have the opportunity to truly
change this traditional paradigm,” said Michael Glassner, MD,
Founding Partner and Medical Director of Main Line Fertility &
Reproductive Medicine in Pennsylvania, where the first patient in
the LOCAL trial was treated in July 2021. “The LOCAL trial is the
next step in proving the FemaSeed localized directional
insemination approach. My colleagues and I are thrilled to be a
part of this patient care evolution.”
The LOCAL trial will be conducted across approximately 20
centers in the United States and is expected to enroll up to 792
patients diagnosed as infertile. The primary endpoints of the study
are to determine the effectiveness (clinical pregnancy rate) and
safety over a period of 7 weeks.
“Infertility has become a global issue and the commencement of
the LOCAL trial underscores our commitment to ensure that women
struggling to become pregnant receive the best, lowest cost
treatment option by developing our innovative directional delivery
platform technology,” said Kathy Lee-Sepsick, founder, President
& Chief Executive Officer of Femasys.
About FemaSeedFemaSeed features intrauterine
directional delivery that deposits sperm locally and directly to
the fallopian tube where conception occurs. As the first and only
approach, presenting significant advantages over existing
artificial insemination solutions, it is intended to become a
first-line treatment for infertility.
About InfertilityInfertility is a major public
health concern, with declining fertility levels and an increase in
the number of countries experiencing a reduction in population
size. In the United States alone, there are over 9 million women
known to be infertile. First-line alternative methods have not been
developed to meet the continuous demand for safe and effective
treatment options that are considerably less costly and less
invasive than assisted reproductive technologies, such as in vitro
fertilization (IVF), a solution not selected by most women.
About FemasysFemasys is a biomedical company
focused on transforming women’s healthcare worldwide by developing
novel solutions and next-generation advancements providing
significant clinical impact to address severely underserved areas.
With an initial focus in the area of reproductive health, its two
lead product candidates offer solutions to improve patient care and
health economics: FemBloc, a first and only non-surgical product
for permanent birth control and FemaSeed, a first and only directed
sperm delivery product for infertility treatment. Femasys’
FemVue product for fallopian tube assessment by ultrasound is
currently marketed in the United States as its main commercial
priority. Femasys has also developed a novel technology platform
for tissue sampling intended to be marketed alongside our
other women-specific medical products in the physician’s
office setting. For more information, please visit
www.Femasys.com.
Forward-Looking StatementsThis 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,” “intend,” “believe,” “potential” 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 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 product candidates; 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 the prospectus related to our initial public offering
filed with the Securities and Exchange Commission on June 21, 2021.
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
Investor Contact:IR@femasys.com
Media Contact:Media@femasys.com
Source: Femasys Inc.
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