FEMY 8-K
Femasys Inc (FEMY)
8-K
2024-09-11
For: 2024-09-11
View Original
Added on
April 06, 2026
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 11, 2024
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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(Address of principal executive offices)
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(Zip Code)
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(770 ) 500-3910
(Registrant’s telephone number, including area code)
n/a
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instructions A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Exchange Act:
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Title of each class
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Trading
Symbol(s)
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Name of each exchange
on which registered
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this
chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new
or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
| Item 8.01 |
Other Events
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On September 11, 2024, Femasys Inc. (the “Company”) issued a press release announcing that it secured strategic distribution partnerships for commercialization of
FemaSeed for over $1.3M in Spanish market. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
| Item 9.01 |
Financial Statements and Exhibits.
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Exhibits.
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Exhibit
No.
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Description
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Press Release of Femasys Inc. dated September 11, 2024
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL Document)
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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Femasys Inc.
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By:
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/s/ Kathy Lee-Sepsick
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Names: Kathy Lee-Sepsick
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Title: Chief Executive Officer
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Date: September 11, 2024
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Exhibit 99.1
Femasys Secures Strategic Distribution Partnerships for Commercialization of FemaSeed® for over $1.3M in Spanish Market
Company taps Comercial Medico Quirurigca, SA and Durgalab as first EU distributors for its CE-marked women’s reproductive healthcare products
ATLANTA – September 11, 2024 - 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 that the Company has secured strategic distribution partnerships for its CE-marked products, including FemaSeed®
and FemVue® in Spain. Comercial Medico Quirurigca, SA (CMQ) will distribute the products in northern
Spain and Durgalab will distribute them in the south. Spain is the first EU country where the Company has identified distributors and began marketing its products.
Kathy-Lee Sepsick, Femasys Founder and CEO commented, “Today’s announcement marks a significant step in our global expansion and reinforces our mission to empower women
across the world with new, innovative and superior healthcare solutions. Our distribution partners have extensive expertise in women’s healthcare and a strong understanding of the value of our infertility portfolio. Their commitment to purchase a
minimum of $1.3 million of FemaSeed over the next year gives us great confidence in their ability to expand access to our affordable and effective solutions for women.”
“It is an honor to partner with Femasys to bring the latest technology for infertility treatment that is more cost-effective than IVF or ICSI and an improvement to
traditional IUI to the Spain market,” said Jordi Pié, CMQ’s Founder and CEO. “We have been preparing as we awaited the availability of Femasys’ products with the CE mark under MDR and are thrilled to provide FemaSeed along with the other diagnostic
products.”
About Spanish Infertility Market
According to the European registries by the European Society of Human Reproduction and Embryology (ESHRE)1, Spain has the most in vitro fertilization (IVF)
clinics with 244 facilities in Europe. Additionally, Spain ranks second in intrauterine (IUI) insemination cycles using husband sperm and holds the top position for IUI cycles using donor sperm.
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.
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:
CORE IR
Matt Blazei
Media:
CORE IR
Kati Waldenburg