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 25, 2023
Femasys Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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001-40492
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11-3713499
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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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3950 Johns Creek Court,
Suite 100
Suwanee, Georgia
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30024
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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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Common Stock, par value $0.001 per share
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FEMY
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The Nasdaq Stock Market LLC
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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 7.01 |
Regulation FD Disclosure
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On September 27, 2023, Femasys Inc. (the “Company”) posted on its website an updated slide presentation, which is attached as Exhibit 99.1 to this Current
Report on Form 8-K and incorporated by reference herein. Representatives of the Company will use the presentation in various meetings with investors, analysts and other parties from time to time.
The information furnished in this Item 7.01 and Exhibit 99.1 attached hereto is being furnished and shall not be deemed “filed” for purposes of Section 18
of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as may be expressly
set forth by specific reference in such filing.
The Company expressly disclaims any obligation to update or revise any of the information contained in the corporate presentation.
On September 25, 2023, Femasys Inc. (the “Company”) announced FDA clearance to market FemaSeed. A copy of the press release is being furnished as Exhibit
99.2 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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Exhibit
No.
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Description
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Femasys Inc. Corporate Presentation dated September 27, 2023.
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Press Release of Femasys Inc. dated September 25, 2023
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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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/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 27, 2023
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Exhibit 99.2
Femasys Inc. Receives U.S. FDA Clearance to Market FemaSeed, an Innovative
Infertility Treatment Solution
- The 510(k) Clearance from the United States Food and Drug
Administration (FDA) allows for the U.S. commercialization of FemaSeed®, an intratubal artificial insemination option designed to augment the natural fertilization process -
- FemaSeed® is an innovative infertility treatment designed to deliver sperm directly to
where conception occurs in a woman’s fallopian tube-
ATLANTA, September 25, 2023 -- Femasys Inc. (NASDAQ: FEMY), a biomedical
company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative diagnostic products, today announced it has
received 510(k) Clearance from the United States Food and Drug Administration (FDA) for FemaSeed®, an innovative infertility treatment designed to deliver sperm directly to where conception occurs in a woman’s fallopian tube.
In recent decades, infertility has affected an increasing number of women - estimated at 10 million in the United States according to the Center for Disease Control (CDC).
Despite incremental advancements, there have been no recent meaningful affordable options. FemaSeed® Intratubal Insemination is a
type of an intrauterine insemination procedure that is less invasive than in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), which we expect would reduce
the chances of procedural complications.
“We are thrilled to receive 510(k) Clearance from FDA for FemaSeed®, an innovative infertility treatment designed to deliver sperm directly to where conception occurs,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “This FDA 510(k) Clearance of FemaSeed
demonstrates our successful collaborative efforts with the FDA to bring forward new technology that will address the significant unmet need for less burdensome infertility treatments.”
Femasys is creating accessible options for women, as exemplified with FemaSeed®, now an FDA-cleared infertility treatment, and its lead product candidate, FemBloc® in late-stage clinical development for permanent birth
control. The Company is commercializing complementary diagnostic products that were internally developed through its in-house manufacturing capabilities, with regulatory approvals in the U.S., Canada and other countries outside the U.S. The FemaSeed procedure works synergistically with FemVue®, Femasys’ FDA-cleared diagnostic device that enables an in-office ultrasound assessment of the fallopian tubes and serves to provide an infertility diagnosis prior to FemaSeed.
Ms. Lee-Sepsick continued, “In recent years, there has been a sharp decline in fertility rates with a downward trajectory of sperm counts and record
low birth rates. At this critical time, we are incredibly gratified that women and couples in the United States struggling with infertility will now have access to a new cost-effective infertility treatment option, in addition to the diagnostic
solutions we have already made available.”
FemaSeed is an innovative infertility treatment designed to deliver sperm to the fallopian tube where conception occurs. It is intended to enhance natural fertilization and provide a
first-line treatment option for infertility. FemaSeed is less invasive and more affordable than assisted reproduction procedures, such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). Femasys is supporting an ongoing
pivotal clinical trial specific for male factor infertility. FemaSeed has achieved U.S. FDA clearance and regulatory approval in Canada.
About Femasys
Femasys is a biomedical company focused on meeting significant unmet needs for women
worldwide with a broad portfolio of in-office, accessible solutions, including a lead revolutionary late-clinical stage product candidate and FDA-cleared, innovative therapeutic and diagnostic products. Femasys’ 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. Femasys’ FemaSeed® Intratubal Insemination, an innovative infertility treatment designed to deliver sperm
directly where conception occurs, is now FDA-cleared (and also approved in Canada). The Company has developed diagnostic products that are complementary for which it has achieved regulatory approvals to market in the U.S., Canada and other non-U.S.
territories, and which are commercial-ready due to its in-house manufacturing capabilities. The Company’s diagnostic products include FemVue® 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,” “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 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 our Annual Report on Form 10-K for the year ended December 31, 2022 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.
Investors
Chuck Padala
LifeSci Advisors, LLC
917-741-7792
chuck@lifesciadvisors.com
Femasys Inc.
Investor Contact:
IR@femasys.com
Media Contact:
Media@femasys.com