Femasys Inc. (Nasdaq: FEMY) has announced a strategic partnership with Carolinas Fertility Institute (CFI), positioning the biomedical company to expand market access for its FemaSeed intratubal insemination product across North Carolina. The collaboration will make FemaSeed available as an infertility treatment option throughout CFI's network of more than 8 locations.
Enhanced Fertility Treatment Access
"Our partnership with Carolinas Fertility Institute reflects the growing momentum behind FemaSeed as a meaningful first-line fertility solution," said Kathy Lee-Sepsick, CEO and Founder of Femasys. "By offering a less invasive and cost-effective option before IVF, we're helping practices expand their treatment offerings while supporting patients earlier in their fertility journey."
Dr. Tamer Yalcinkaya, Founder and Medical Director of CFI, emphasized the alignment with the institute's mission: "At Carolinas Fertility Institute, we are always looking for innovative ways to make fertility care more accessible, effective, and patient-friendly. FemaSeed offers an exciting new first-line treatment option that complements our mission to provide advanced, yet affordable and less invasive care."
Clinical Performance Data
FemaSeed represents a next-generation artificial insemination solution that enhances fertilization by precisely delivering sperm to the fallopian tube, the natural site of conception. In the pivotal clinical trial (NCT0468847), FemaSeed achieved over double the pregnancy rates of traditional intrauterine insemination (IUI) in cases of low male sperm count, according to published clinical trial data.
The treatment is positioned as an affordable, less invasive, lower-risk option before patients consider IVF. FemaSeed has received authorization for use in the United States, Europe, United Kingdom, Canada, and Israel.
Expanding Commercial Footprint
Carolinas Fertility Institute operates as a leading fertility center serving patients across North Carolina and the Southeast, with locations in Winston-Salem, Greensboro, and Charlotte. The institute offers personalized, evidence-based reproductive care including IVF, IUI, fertility preservation, and advanced diagnostic services.
Femasys describes itself as a leading biomedical innovator focused on addressing critical unmet needs in women's health with a broad, patent-protected portfolio of disruptive, accessible, in-office therapeutic and diagnostic products. The company's fertility portfolio includes FemaSeed Intratubal Insemination and FemVue, a companion diagnostic for fallopian tube assessment.
Broader Product Pipeline
Beyond fertility treatments, Femasys is developing FemBloc permanent birth control, described as the first and only non-surgical, in-office alternative to centuries-old surgical sterilization. The company expects full regulatory approval in Europe mid-year 2025, with commercialization beginning in Spain through engaged partnerships followed by select European countries.
Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction for FemBloc. For U.S. FDA approval, enrollment in the FINALE pivotal trial (NCT05977751) is ongoing.
