FEMY News & Events

Femasys announced the initiation of patient enrollment in the FINALE pivotal clinical trial evaluating FemBloc. This milestone follows U.S. Food and Drug Administration, FDA, Investigational Device Exemption, IDE, approval to advance the study based on positive clinical data generated in its earlier phase. FemBloc has already received regulatory approvals and is being commercialized in Europe and other select countries outside the United States as a non-surgical alternative to the surgical procedures currently used for permanent birth control. Completion of the FINALE study is expected to support a future U.S. regulatory submission.

Femasys announced that its FemBloc permanent birth control system has achieved certification under the Medical Device Single Audit Program, MDSAP. The MDSAP certification positions the Company to accelerate regulatory and commercial execution across key global markets, including the United States, Canada, Japan, Australia, and Brazil. In the U.S., FDA recognition of MDSAP reflects a high level of quality system maturity and supports regulatory readiness as the Company advances its trial toward PMA submission.

Femasys announced that it has received notice from the American Medical Association, AMA, CPT Editorial Panel approving a new Category III Current Procedural Terminology, CPT, code covering the use of FemaSeed for intratubal insemination, ITI, a procedure that delivers sperm directly into the fallopian tube where conception occurs. The approved Category III CPT code is expected to be issued publicly by the AMA with an effective date of January 1, 2027. Approval of this Category III CPT code represents an important step in advancing the reimbursement strategy for FemaSeed to support broader clinical adoption, provider utilization, and expanded patient access to this first-step infertility treatment option. "The creation of a new Category III code for the FemaSeed ITI procedure reflects the innovation and differentiated approach of our technology," said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. "As we initiate the rollout of FemaSeed to gynecologists and their clinical teams, supported by the availability of our FemSperm product line, we intend to expand our provider footprint, accelerate adoption, and increase access to care for more than 10 million women in the U.S. affected by infertility. Together, these offerings advance our scalable commercialization strategy and position us for sustainable long-term growth."