Femasys Advances FemBloc Toward U.S. Approval with Initiation of Pivotal Trial Enrollment
Rhea-AI Summary
Femasys (NASDAQ: FEMY) has begun patient enrollment in the FDA-authorized FINALE pivotal trial of FemBloc, a first-of-its-kind non-surgical permanent birth control. The move follows an FDA Investigational Device Exemption approval and positive earlier clinical data. FemBloc is already approved and commercialized in Europe and select countries outside the U.S., and completion of FINALE is expected to support a future U.S. regulatory submission.
Positive
- FDA granted an IDE to advance the pivotal FINALE trial
- Patient enrollment initiated in the pivotal FINALE study
- FemBloc already approved and commercialized in Europe and select countries
- Non-surgical permanent birth control may expand access and reduce surgery risks
Negative
- No U.S. approval yet; commercial U.S. launch depends on FINALE completion
- Pivotal trial outcomes remain pending and will determine regulatory fate
News Market Reaction – FEMY
In the Mar 10 session, FEMY gained 2.64%, reflecting a moderate positive market reaction. Argus tracked a peak move of +6.3% during that session. Argus tracked a trough of -2.7% from its starting point during tracking. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Feb 26 | Regulatory certification | Positive | -1.1% | FemBloc MDSAP certification to accelerate multi-country regulatory and commercial execution. |
| Feb 23 | Reimbursement milestone | Positive | +1.6% | AMA approval of Category III CPT code to support FemaSeed reimbursement and adoption. |
| Feb 03 | Commercial expansion | Positive | +1.4% | Swiss distribution agreement expanding FemBloc, FemaSeed and diagnostics in Europe. |
| Jan 14 | Listing compliance | Negative | +17.8% | Nasdaq 180-day extension to regain $1.00 minimum bid price compliance. |
| Jan 13 | Access partnership | Positive | -1.5% | Partnership with Refuah Health Center to expand community-based access to FemaSeed. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent company-specific news often saw mixed reactions, with several positive operational updates producing divergent price moves.
Over the past few months, Femasys reported multiple milestones tied to FemBloc and its broader women’s health portfolio. On Feb 26, 2026, FemBloc achieved MDSAP certification to support global expansion and pivotal trial readiness, yet the stock moved -1.12%. A new Category III CPT code for FemaSeed on Feb 23, 2026 and a Swiss distribution deal on Feb 3, 2026 saw modest gains of 1.57% and 1.43%. A Nasdaq 180-day extension on Jan 14, 2026 produced a stronger 17.81% move. Today’s pivotal trial enrollment continues this regulatory and commercial progression.
Key Terms
investigational device exemption regulatory
investigational device exemption (ide) regulatory
permanent birth control medical
fallopian tubes medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
-- Enrollment begins in the FDA-authorized FINALE pivotal trial evaluating FemBloc, a first-of-its-kind non-surgical permanent birth control, following positive clinical data --
ATLANTA, March 10, 2026 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide, announced today 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.
“Initiating patient enrollment in the final phase of the FINALE trial marks an important milestone toward unlocking the U.S. market for FemBloc and reflects our continued commitment to advancing women’s healthcare,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. “Following years of development, clinical validation, and regulatory progress, including approvals outside the United States, this pivotal trial represents the final step in executing our U.S. strategy and advancing long-term value creation for Femasys stakeholders.”
“Having been involved in the FemBloc clinical program from its early studies through this pivotal phase, I am pleased to see the FINALE trial advance to its final stage,” said Dr. Scott Chudnoff, Principal Investigator of the FINALE trial, Chair of Obstetrics & Gynecology at Maimonides Medical Center. “A non-surgical approach has the potential to expand access while reducing the risks associated with surgery, addressing a longstanding unmet need for women in the U.S.”
Permanent birth control is one of the most widely used contraceptive methods worldwide, yet current options require surgery, anesthesia, abdominal incisions, and recovery time, introducing procedural risks and increasing healthcare costs. FemBloc is a first-of-its-kind, non-surgical solution designed to address this unmet need in women’s reproductive health. Using a patented delivery system, FemBloc places a proprietary blended polymer into both fallopian tubes, where it safely degrades and forms natural scar tissue for permanent occlusion. By eliminating the complexities associated with surgical sterilization, FemBloc has the potential to expand access to permanent contraception while reducing the burden on healthcare systems. Millions of women worldwide undergo surgical procedures for permanent birth control each year, highlighting the need for a non-surgical alternative.
About the FINALE Pivotal Clinical Trial
The FINALE (Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control) trial is a prospective, multi-center, open-label, single-arm pivotal study evaluating the safety and effectiveness of FemBloc. An initial roll-in enrollment of 50 women was completed to assess preliminary safety data, together with data from prior IDE-approved studies, after which the U.S. Food and Drug Administration (FDA) authorized continuation of the trial to enroll the remaining participants. The primary endpoint is pregnancy rate, assessed after 401 women have used FemBloc for one year, with an interim analysis planned after 300 participants complete one year of use. Participants will be followed annually for five years post-procedure. For more information, visit www.FemBloc.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 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
