Femasys 8-K: Australian and New Zealand clearance for key fertility products

Rhea-AI Filing Summary

Femasys Inc. (Nasdaq: FEMY) filed a Form 8-K to disclose a material event under Item 8.01 (Other Events).

• On July 1, 2025, the Company issued a press release (Exhibit 99.1) announcing that it has obtained regulatory approvals in Australia and New Zealand for two products:
  • FemaSeed for first-line infertility treatment
  • FemVue diagnostic system
• No financial results, transaction details, or forward-looking guidance were included in the filing.
• The disclosure is limited to the announcement; the full press release is incorporated by reference but not reproduced in the 8-K.

The Company indicates it remains an emerging growth company.

Positive

• Regulatory approvals obtained for FemaSeed and FemVue in both Australia and New Zealand, expanding geographic market access.

Negative

• None.

Insights

Medical Devices Analyst

TL;DR – Regulatory clearances open new markets; modest but positive catalyst.

The dual approvals grant Femasys immediate entry into the Australian and New Zealand fertility and diagnostics markets without additional regulatory hurdles. While the filing provides no sales projections, access to two developed healthcare systems broadens the commercial footprint beyond the United States and could accelerate adoption curves for both FemaSeed and FemVue. Because infertility solutions and hysterosalpingography alternatives are high-margin niches, even modest share capture can be accretive for a small-cap company. Investors should monitor upcoming distribution agreements and reimbursement codes to gauge revenue impact.

Securities Analyst

TL;DR – Positive non-financial event; watch for revenue follow-through.

The 8-K signals strategic progress rather than immediate financial change. Regulatory approvals in two countries reduce time-to-market risk and strengthen Femasys’ intellectual-property narrative, useful for future capital raises or partnerships. However, absent unit targets or pricing data, the near-term P&L effect remains uncertain. The market is likely to view the news favorably, but the valuation upside will depend on commercial execution detailed in future filings or earnings calls.

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 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): July 1, 2025

Femasys Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-40492	11-3713499
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

3950 Johns Creek Court, Suite 100 Suwanee, Georgia		30024
(Address of principal executive offices)		(Zip Code)

(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):

☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Exchange Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		FEMY		The Nasdaq Stock Market LLC

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

On July 1, 2025, Femasys Inc. (the “Company”) issued a press release announcing the achievement of Australian and New Zealand Regulatory Approvals for FemaSeed for First-Line Infertility Treatment and FemVue Diagnostic. 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.

(d) Exhibits.

Exhibit No.	Description
99.1	Press Release of Femasys Inc. dated July 1, 2025.

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.

	Femasys Inc.
	By:	/s/ Kathy Lee-Sepsick
	Names: Kathy Lee-Sepsick
	Title: Chief Executive Officer
Date: July 1, 2025

FAQ

What did Femasys (FEMY) announce in its July 1, 2025 8-K?

The company reported regulatory approvals in Australia and New Zealand for its FemaSeed infertility treatment and FemVue diagnostic product.

Which products received approval for Femasys?

FemaSeed (first-line infertility treatment) and FemVue diagnostic system.

Does the 8-K include financial results or revenue projections?

No, the filing contains no financial data or revenue forecasts.

Where can investors find the full details of the announcement?

The complete press release is furnished as Exhibit 99.1 to the 8-K and incorporated by reference.

Is Femasys still classified as an emerging growth company?

Yes, the filing confirms the company’s emerging growth company status under SEC rules.