Femasys Receives AMA CPT Editorial Panel Approval for New Category III CPT Code for FemaSeed Intratubal Insemination
Rhea-AI Summary
Femasys (NASDAQ: FEMY) received AMA CPT Editorial Panel approval for a new, unique Category III CPT code covering FemaSeed intratubal insemination (ITI). The code is expected to be issued publicly with an effective date of January 1, 2027.
This coding approval advances the company’s U.S. reimbursement strategy to support broader clinical adoption, provider rollout with the FemSperm product line, and expanded patient access; FemaSeed’s pivotal trial (NCT0468847) showed >2x pregnancy rates versus IUI. FemaSeed is authorized for use in the U.S., Europe, UK, Canada, and Israel.
Positive
- AMA approved a new Category III CPT code for FemaSeed ITI, effective Jan 1, 2027
- Clinical trial (NCT0468847) showed more than double pregnancy rates versus IUI
- Authorized for use in U.S., Europe, UK, Canada, and Israel
Negative
- Category III codes are temporary and do not guarantee universal payer reimbursement
- No financial guidance or quantified revenue impact tied to the CPT approval in the announcement
Key Figures
Market Reality Check
Peers on Argus
FEMY is down 0.82% while peers flagged by momentum (HBIO, EKSO) show upside moves, indicating today’s action is more stock-specific than sector-driven.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 03 | European expansion deal | Positive | +1.4% | New Swiss distribution agreement expanding European commercial footprint. |
| Jan 14 | Nasdaq compliance extension | Positive | +17.8% | Nasdaq grants 180-day extension to regain $1.00 minimum bid compliance. |
| Jan 13 | Access partnership | Positive | -1.5% | Partnership with Refuah Health Center to expand first-line FemaSeed access. |
| Dec 18 | FDA device clearance | Positive | +4.1% | U.S. FDA 510(k) clearance for next-generation FemVue diagnostic device. |
| Nov 14 | Earnings and updates | Positive | +8.6% | 3Q25 results with revenue growth, financings, and multiple regulatory milestones. |
Operational and regulatory milestones have often been followed by positive next-day moves, though not uniformly so.
Over the last few months, Femasys reported multiple commercial and regulatory milestones. European distribution expansion for FemBloc and FemaSeed on Feb 3, 2026, a Nasdaq bid-price extension on Jan 14, 2026, and a community-care partnership on Jan 13, 2026 all focused on broadening access and maintaining listing status. FDA 510(k) clearance for the next‑gen FemVue device on Dec 18, 2025 and 3Q25 results with revenue growth and new financings on Nov 14, 2025 further built the platform. Today’s CPT code approval reinforces this commercialization and access trajectory.
Regulatory & Risk Context
The company has an active S-3 shelf registration filed on Jul 3, 2025, expiring on Jul 3, 2028. It is not yet effective and shows 1 recorded usage via a 424B3 filing on Jan 9, 2026, but no registered dollar capacity is specified in the provided data.
Market Pulse Summary
This announcement highlights a key reimbursement milestone: AMA approval of a unique Category III CPT code for FemaSeed intratubal insemination, expected to take effect on Jan 1, 2027. It supports broader clinical adoption and patient access for an infertility treatment targeting more than 10 million U.S. women. In context of recent European expansion, partnerships, and FDA clearance for FemVue, this reinforces Femasys’ focus on commercial scaling while prior filings underscore ongoing financing and listing-status considerations.
Key Terms
current procedural terminology (cpt) regulatory
intratubal insemination medical
in vitro fertilization (ivf) medical
pivotal clinical trial medical
AI-generated analysis. Not financial advice.
-- Advances reimbursement strategy in the U.S. for FemaSeed, an intended first-step infertility treatment --
ATLANTA, Feb. 23, 2026 (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 that it has received notice from the American Medical Association (AMA) CPT Editorial Panel approving a new, unique 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.”
FemaSeed is a next-generation artificial insemination solution that enhances fertilization by precisely delivering sperm to the fallopian tube, the natural site of conception. Developed to bridge the gap between traditional intrauterine insemination (IUI), which often has low success rates, and in vitro fertilization (IVF), which is costly and invasive, FemaSeed offers a safe, effective, accessible, and cost-efficient first-line, in-office treatment option. In its pivotal clinical trial (NCT0468847), conducted in the challenging setting of low male sperm count, FemaSeed achieved more than double the pregnancy rates of IUI.1 FemaSeed is authorized for use in the U.S., Europe, UK, Canada, and Israel. Learn more at www.femaseed.com.
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 (ITI), a groundbreaking first-step infertility treatment; FemSperm®, a CLIA waived sperm preparation and analysis product line; and FemVue®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrate that FemaSeed achieved more than double the pregnancy rates of 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, the UK 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 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 does the new Category III CPT code mean for Femasys (FEMY) and reimbursement?
How might the Category III CPT code affect Femasys (FEMY) provider adoption and rollout?
What clinical evidence supports FemaSeed and how did it perform in trials (FEMY)?
When will the new CPT code for FemaSeed (FEMY) take effect and who issued it?
Is FemaSeed available internationally and what markets are authorized for use (FEMY)?
