Femasys Closes $8 Million in Financing to Accelerate Commercialization of Fertility and Birth Control Portfolios

Rhea-AI Summary

Femasys (NASDAQ: FEMY) has secured $8 million in financing to accelerate the commercialization of its innovative women's health products. The funding, backed by existing investors including the company's largest shareholders, will support the expansion of their FemaSeed® fertility treatment and FemBloc® non-surgical permanent birth control solutions.

The company has achieved significant milestones in 2025, including regulatory approvals for FemBloc in Europe and the UK, introduction of the FemSperm™ Setup Kit, and a $400,000 commercial order from Spain. Additional achievements include regulatory approvals for FemaSeed in Australia and New Zealand, and a partnership with Carolinas Fertility Institute.

Positive

• None.

Negative

• Company still in early commercialization phase with limited revenue

Insights

Healthcare Investment Analyst

Femasys' $8M financing strengthens commercialization of innovative women's health products with recent regulatory wins and market expansion.

The $8 million financing secured by Femasys represents a crucial capital infusion at a pivotal commercialization stage for their dual-product portfolio targeting massive markets. This funding directly addresses the capital-intensive nature of medical device commercialization, especially critical for a company with $4.4 million in cash reported last quarter.

The vote of confidence from existing investors, particularly their largest shareholders, is significant during challenging biotech funding environments. This suggests strong insider belief in near-term commercial execution rather than just long-term potential.

The company's regulatory momentum is impressive, with both FemBloc (non-surgical permanent birth control) and FemaSeed (fertility treatment) receiving approvals across multiple international markets in quick succession. The $400,000 initial order from Spain represents tangible evidence of commercial traction, though still modest relative to overall market potential.

The strategic appointment of a Chief Commercial Officer signals appropriate focus on revenue generation. Meanwhile, the partnership with Carolinas Fertility Institute establishes an initial distribution foothold across eight locations—crucial for proving clinical adoption before larger-scale rollout.

The personal investment rationale from largest shareholder Jorey Chernett adds unique perspective on FemBloc's potential to address a serious safety gap in permanent contraception methods. This first-hand testimonial reinforces both the clinical need and emotional resonance of their product offerings.

--Existing investors, including Femasys’ largest shareholders, reaffirm confidence in Femasys’ strategy for growth and impact in women’s health--

ATLANTA, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced today the closing of $8 million in financing. This funding will provide critical resources to accelerate commercialization efforts and strengthen the company’s ability to address significant unmet needs in women’s reproductive health. To underscore this momentum, Femasys’ largest shareholder, Jorey Chernett also provided commentary on the company’s mission and recent milestones.

“Ramping commercialization of our FemaSeed^® and FemBloc^® offerings remains our highest priority, and this financing enables us to execute on our strategy, achieve near-term milestones, strengthen our market presence, and accelerate toward meaningful revenue growth,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys, Inc. “We are especially grateful for the continued support of our two largest shareholders, including Jorey Chernett, whose belief in our mission affirms the long-term value we are creating for investors and the women we serve.”

Jorey Chernett, CEO and Founder of Clearpath and Managing Member of Pointillist Family Office, commented, “FemBloc addresses a long overdue need in women’s health. My family experienced the greatest loss when my mother passed away during a tubal ligation surgery, which was the only option available to women for permanent contraception until FemBloc. No woman should ever die from an elective procedure, and FemBloc eliminates this risk. As a long-time healthcare executive and entrepreneur, I also recognize the important work Femasys is advancing in infertility care. Their FemaSeed product fills a critical void in the market and offers another groundbreaking option for women. I am honored to support this mission, and as an experienced investor, I am confident my commitment will help bring these transformative products to women while creating meaningful value for shareholders.”

Recent Femasys milestones announced in the second half of 2025 include:

• Regulatory approvals of FemBloc non-surgical permanent birth control in Europe (June 25) and the United Kingdom (August 20)
• Introduction of FemSperm™ Setup Kit, the first in the product family, enabling activation of FemaSeed, a first-step infertility treatment, in the gynecologist’s office (August 21)
• First commercial entry into Europe with a $400,000 USD order for FemBloc in Spain (August 6)
• Regulatory approval for FemaSeed in Australia and New Zealand (July 1)
• Appointment of a Chief Commercial Officer to drive portfolio revenue growth (June 17)
• Partnership with Carolinas Fertility Institute, one of the nation’s top fertility clinics, to offer FemaSeed across its eight locations (June 11)

About Femasys
Femasys is a leading biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide through its broad, patent-protected portfolio of novel, in-office therapeutic and diagnostic products. As a U.S. manufacturer with global regulatory approvals, Femasys is actively commercializing its lead product innovations in the U.S. and key international markets. Femasys’ fertility portfolio includes FemaSeed^® Intratubal Insemination, a groundbreaking first-step infertility treatment and FemVue^®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrates FemaSeed is over twice as effective as traditional IUI, with a comparable safety profile, and high patient and practitioner satisfaction.¹

FemBloc^® permanent birth control is the first and only non-surgical, in-office alternative to centuries-old surgical sterilization that received full regulatory approval in Europe in June of 2025 and the United Kingdom in August 2025. Commercialization of this highly cost-effective, convenient and significantly safer approach will be completed through strategic partnerships in select European countries. Alongside FemBloc, the FemChec^®, diagnostic product provides an ultrasound-based test to confirm procedural success. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction.² For U.S. FDA approval, enrollment in the FINALE pivotal trial (NCT05977751) is on-going.

Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.

References
¹Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, Lee-Sepsick, K. (2024). FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12. doi: 10.33140/JGRM.08.02.08.

²Liu, J. H., Blumenthal, P. D., Castaño, P. M., Chudnoff, S. C., Gawron, L. M., Johnstone, E. B., Lee-Sepsick, K. (2025). FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes. J Gynecol Reprod Med, 9(1), 01-12. doi: 10.33140/JGRM.09.01.05.

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 obtain regulatory approvals for our FemBloc product candidate; develop and advance our current FemBloc product candidate and successfully enroll and complete the clinical trial; the ability of our clinical trial to demonstrate safety and effectiveness of our product candidate and other positive results; estimates regarding the total addressable market for our products and product candidate; our ability to commercialize our products and product candidate, our ability to establish, maintain, grow or increase sales and revenues, 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, 2024, 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:
David Gutierrez, Dresner Corporate Services, (312) 780-7204, dgutierrez@dresnerco.com
Nathan Abler, Dresner Corporate Services, (714) 742-4180, nabler@dresnerco.com

FAQ

What is the size of Femasys (FEMY) recent financing round in 2025?

Femasys secured $8 million in financing from existing investors, including its largest shareholders, to accelerate commercialization of its fertility and birth control products.

What are the main products in Femasys (FEMY) portfolio?

Femasys' main products include FemaSeed® for fertility treatment, FemBloc® for non-surgical permanent birth control, and the newly introduced FemSperm™ Setup Kit.

What regulatory approvals did Femasys (FEMY) receive in 2025?

In 2025, Femasys received regulatory approvals for FemBloc in Europe (June) and UK (August), and FemaSeed approval in Australia and New Zealand (July).

What is the value of Femasys' first commercial order in Europe?

Femasys received its first commercial order in Europe worth $400,000 USD for FemBloc from Spain in August 2025.

Which major fertility clinic partnership did Femasys announce in 2025?

Femasys partnered with Carolinas Fertility Institute, one of the nation's top fertility clinics, to offer FemaSeed across its eight locations in June 2025.