Femasys Inc. announced that the American Medical Association’s CPT Editorial Panel has approved a new Category III Current Procedural Terminology code for its FemaSeed intratubal insemination (ITI) procedure, with the code set to be publicly issued on January 1 2027. The approval expands reimbursement options for the company’s first‑step infertility treatment and is expected to accelerate adoption by gynecologists and broaden patient access to a cost‑effective, in‑office fertility option.
The approval follows a pivotal clinical trial (NCT0468847) in which FemaSeed achieved a 26.3 % pregnancy rate per subject and a 17.5 % rate per cycle, more than double the 6.7 % pregnancy rate typically seen with traditional intrauterine insemination. Safety outcomes were comparable to IUI, with only mild adverse events reported and no new safety concerns identified.
By securing the CPT code, Femasys strengthens its commercial strategy for its infertility portfolio. The new code will enable insurers to reimburse the ITI procedure, encouraging broader provider adoption and increasing the patient base for FemaSeed. The company’s broader women's‑health strategy, which includes the non‑surgical permanent birth‑control product FemBloc, benefits from the same reimbursement pathway, positioning Femasys to capture a larger share of the U.S. fertility market and generate additional revenue streams as it pursues FDA approval for FemBloc.
"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, CEO and Founder of Femasys. "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."
Femasys has received regulatory approvals for FemBloc in Europe, the United Kingdom, and New Zealand in 2025, and secured a U.S. FDA Investigational Device Exemption in November 2025 to continue enrollment in the final phase of the FemBloc pivotal trial. The company’s recent financial results show a Q3 2025 EPS of –$0.10 versus an estimate of –$0.13, and revenue of $729 k versus an estimate of $1.35 M. For Q4 2025, analysts expect an EPS of –$0.08 and revenue of $1.14 M.
The CPT code approval represents a significant regulatory milestone that could unlock new reimbursement streams and accelerate market penetration for FemaSeed, while also reinforcing Femasys’ broader strategy to expand its women's‑health portfolio. The company’s ongoing clinical and regulatory progress, coupled with the strong clinical data supporting FemaSeed, positions it to capitalize on the growing demand for effective, affordable fertility solutions in the United States.
The content on EveryTicker is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.