OEM News

Femasys Expands FemSperm Product Line 

Following the Setup Kit, the Insemination Kit completes the sperm preparation portion of FemSperm.

By: Michael Barbella

Managing Editor

Femasys Inc. has introduced to market its FemSperm Insemination Prep Kit, a product designed to fully enable gynecologists to perform FemaSeed Intratubal Insemination. The kit includes customized components such as sperm washing for specific use with the FemSperm Setup kit to optimize sperm preparation for FemaSeed procedures.

This offering marks a key milestone in advancing Femasys’ gynecology-focused commercialization strategy for the FemaSeed platform and reinforces the company’s determination to capture significant share in the large, underserved fertility market. By providing a streamlined, in-office solution, the company is creating a foundation for gynecologist-driven adoption of FemaSeed as a first-step fertility treatment, broadening patient access to alternatives ahead of IVF and strengthening its long-term revenue growth strategy, Femasys bigwigs claim.

“The availability of the FemSperm Insemination Prep Kit completes the sperm preparation process required for FemaSeed and enables tens of thousands of gynecologists to offer our first-step fertility solution directly within their practices,” Femasys Founder/CEO Kathy Lee-Sepsick said. “Until now, most gynecologists have lacked a convenient method for sperm preparation. With an estimated 10 million U.S. women facing infertility and only about 200,000 IVF transfer cycles performed each year, the vast majority never reach a referral infertility center. By removing this barrier, we are making fertility care more accessible where women already receive care, at their gynecologist’s office.”

With the availability of the FemSperm product family, gynecologists can now perform sperm preparation and offer FemaSeed Intratubal Insemination directly within their practices. FemaSeed is a next-generation artificial insemination solution that enhances natural fertilization by delivering sperm precisely to the fallopian tube, the site of conception. Positioned as a true first step in the fertility journey, FemaSeed offers a safe, accessible, and cost-effective alternative to intrauterine insemination (IUI). In its pivotal trial, FemaSeed achieved more than double the pregnancy rates of IUI in cases of low male sperm count.1 As an affordable, less invasive, lower-risk option before IVF, FemaSeed is authorized for use in the United States, Europe, United Kingdom, Canada, Israel, Australia, and New Zealand.

Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide through its patent-protected portfolio of 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 United States and key international markets. Femasys’ fertility portfolio includes FemaSeed Intratubal Insemination, a 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 2025, United Kingdom in August 2025, and New Zealand in September 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 Enrollment in the FINALE pivotal trial (NCT05977751) is on-going for U.S. Food and Drug Administration approval.

References
1 Liu, 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.
2 Liu, 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.

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