Femasys, Inc., (Nasdaq: FEMY), a leading biomedical company focused
on addressing significant unmet needs of women worldwide with a
broad portfolio of in-office, accessible, and innovative
therapeutic and diagnostic products, announces a partnership with
Boston IVF, one of the largest providers of fertility services in
the U.S. Boston IVF will provide the Company’s FemaSeed intratubal
insemination product as an infertility treatment option to patients
throughout its network of locations in the U.S.
“We are elated to welcome Boston IVF, a prominent conglomerate
in the infertility space, to our growing group of providers
offering our FemaSeed treatment to their patients looking for
fertility solutions,” said Femasys CEO Kathy Lee-Sepsick. “Our
partnership with Boston IVF exemplifies our shared commitment to
the expansion of infertility treatment options with groundbreaking
technologies for women and couples. FemaSeed’s accessibility as an
efficacious alternative to intrauterine insemination (IUI) and
prior to in vitro fertilization (IVF) stands to enhance practice
economics while satisfying the needs of patients particularly at
the beginning of their journey.”
FemaSeed delivers sperm directly and safely into the fallopian
tube where conception occurs. It is intended to enhance
natural fertilization and provide a first-line treatment option for
those seeking pregnancy through artificial insemination. When
compared to other reproductive technologies, FemaSeed demonstrated
significantly higher efficacy as compared to historic intrauterine
insemination for low male sperm count and is a safe, highly
cost-effective option prior to IVF and intracytoplasmic sperm
injection (ICSI).
David Stern, CEO of Boston IVF commented, “As pioneers in
reproductive healthcare and research, our team at Boston IVF is
always looking for innovative technologies that expand choices and
improve potential outcomes for our patients. We believe additional
options are needed in infertility treatment and believe FemaSeed
will be a valuable addition to our suite of patient options.”
Dr. Jamil Mroueh, reproductive endocrinologist with Boston IVF
added, “I worked extensively with FemaSeed during our initial
clinical evaluation and was consistently impressed with the ease of
use and patient satisfaction to this new treatment. My patients
expressed their excitement over FemaSeed as a new advancement and I
believe we will be able to help more women now that we can provide
this important treatment widely.”
About FemaSeed
FemaSeed® is an innovative advancement in artificial
insemination, designed to enhance fertilization by precisely
delivering sperm into the fallopian tube, the natural site of
conception. It is intended to be a first-line therapeutic choice
for infertile women, men, and couples seeking pregnancy through
insemination, offering a safe, accessible, and cost-effective
approach. FemaSeed is a revolutionary device that allows healthcare
professionals an ability to expand practice services with a more
affordable and safer alternative to assisted reproductive methods,
such as in vitro fertilization (IVF). FemaSeed received U.S. FDA
clearance (September 2023) and regulatory approval in Canada (April
2023) and CE mark for Europe (June 2024). At the end of the fourth
quarter of 2023, Femasys concluded a prospective, multi-center,
unblinded pivotal clinical trial (NCT0468847) for those seeking
intratubal insemination with FemaSeed. Adverse events were
consistent with intrauterine insemination (IUI). Efficacy analysis
focused on male factor (1 million to 20 million TMSC). In this
population, pregnancy rate was 26.3% by subject (n=38) and 17.5% by
cycle (n=57) after FemaSeed. In contrast, a 6.7% pregnancy rate by
cycle was described in the literature for intrauterine insemination
(IUI) with male factor (greater than 1 million TMSC).1 In market
research of 1,000 infertile women, Femasys found that more than 7
in 10 women were extremely or very likely to consider insemination
with FemaSeed; for those who received IVF, 88% would have preferred
FemaSeed prior to moving on to IVF; and 85% who received IUI would
have preferred FemaSeed instead of IUI. The topline data and market
research provide strong support for the on-going commercial launch,
currently in progress. Learn more at www.femaseed.com.
About Femasys
Femasys is a leading biomedical company focused on addressing
significant unmet needs of women worldwide with a broad portfolio
of in-office, accessible, and innovative therapeutic and diagnostic
solutions, including a lead revolutionary product candidate and
FDA-cleared products. FemaSeed® Intratubal Insemination, an
innovative infertility treatment designed to deliver sperm directly
where conception occurs, is FDA-cleared and has received regulatory
approval in Canada and Europe. FemBloc® permanent birth
control in late-stage clinical development is the first and only
non-surgical, in-office, permanent birth control method intended to
be a safer option for women at substantially less cost than the
long-standing surgical alternative. The Company has developed
diagnostic products that are complementary for which it has
achieved regulatory approvals to market in the U.S., Canada,
Europe, and other ex-U.S. territories, and which are
commercial-ready due to its in-house manufacturing capabilities.
Its diagnostic products include FemVue® and FemVue® MINI for
fallopian tube assessment by ultrasound, which can be used in
conjunction with FemCath®, an intrauterine catheter for selective
fallopian tube evaluation, and FemCerv®, an endocervical tissue
sampler for cervical cancer diagnosis. Learn more at
www.femasys.com, or follow us on X, Facebook and LinkedIn.
About Boston IVF
Boston IVF is one of the largest and most experienced fertility
networks in the United States, with more than 150,000 babies born
since 1986. Founded as one of the nation's first private practice
IVF centers, the Boston IVF network has grown to include 40
reproductive endocrinologists across nearly 30 centers throughout
Massachusetts, Maine, New Hampshire, Rhode Island, New York,
Delaware, Idaho, Indiana, North Carolina, Ohio, and Utah. A
renowned innovator of reproductive technologies, advanced
protocols, and cutting-edge research, Boston IVF has achieved
numerous "firsts" in reproductive care. Its scientific and research
arm continues to pave the way for breakthroughs in fertility care
and its accredited REI Fellowship Program has graduated numerous
reproductive endocrinologists as part of its mission to train the
next generation of fertility experts. In 2024, Boston IVF joined
the global IVI RMA Network, contributing to the network's
management of more than 20+ labs and 60 satellites across North
America. Contact us at: 888.300.BIVF; www.bostonivf.com
Reference
- Duran et al. (2002) Intrauterine
insemination: a systematic review on determinants of success. Human
Reproduction, vol.8, no. 4, pp. 373-384.
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, 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: Matt BlazeiIR@femasys.com
Media Contact: Kati WaldenburgMedia@femasys.com
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