Femasys Doubles Enrolling Sites in FemBloc FINALE Pivotal Trial for Non-Surgical Permanent Birth Control
The trial targets one-year pregnancy-rate data for an FDA submission, while European approval enables post-market data collection.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Femasys (FEMY) has doubled actively enrolling sites in its FemBloc FINALE pivotal trial to twelve across the United States. Baylor Research Institute and Columbia University Medical Center have joined the network of academic centers and private practices studying non-surgical permanent birth control. Femasys said its August 2026 financing enabled progress in the trial.
The study evaluates safety and effectiveness. Enrollment of an initial 50-woman safety cohort is complete; those data and prior study data supported FDA authorization to continue enrollment. The primary endpoint is pregnancy rate after 401 women have relied on FemBloc for one year, with an interim analysis planned after 300 women reach that milestone. Femasys plans to seek FDA approval using one-year data, with annual follow-up continuing for five years. European approval enables collection of post-market real-world data.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointInitial safety cohort enrollment completed with 50 women, supporting FDA authorization to continue enrollment alongside prior study data.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Femasys plans an FDA approval submission based on one-year data under the FDA-approved protocol.
- Minor pointActively enrolling FINALE trial sites doubled to twelve across the United States.
- Minor pointFemBloc's European approval enables collection of post-market real-world data.
Negative
- None.
Key Figures
- Actively enrolling sites
- 12 sites
- FemBloc FINALE pivotal trial across the U.S.
- Initial roll-in cohort
- 50 women
- Completed to assess preliminary safety
- Primary endpoint assessment
- 401 women
- Pregnancy rate after one year of reliance on FemBloc
- Interim analysis
- 300 women
- Planned after one year of reliance
- Annual follow-up
- 5 years
- Continues after submission based on one-year data
Historical Context
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FDA approved a modular PMA submission approach for FemBloc ahead of final clinical data.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
open-label medical
single-arm study medical
primary endpoint medical
interim analysis medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
-- Twelve academic and private clinical sites across the U.S. broaden patient access to the pivotal trial as Femasys advances FemBloc toward potential FDA approval --
ATLANTA, Oct. 14, 2026 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator developing transformative fertility and non-surgical permanent birth control solutions designed to improve the standard of care, expand access, and reduce costs for women worldwide, announced today that it has doubled the number of actively enrolling sites in its FemBloc® FINALE Pivotal Trial to twelve across the United States. The coast-to-coast network of academic centers and private clinical practices now includes Baylor Research Institute and Columbia University Medical Center, joining existing academic sites Maimonides Medical Center, Stanford University, University of California Davis and the University of Utah. Participation by these prominent centers reflects broad clinical interest in advancing permanent birth control options for women through this landmark study and marks continued progress in Femasys’ U.S. clinical program.
“Our August 2026 financing has enabled us to meaningfully advance the FINALE trial, and doubling our investigative sites demonstrates important progress in executing on our U.S. regulatory strategy,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. “FemBloc’s approval in Europe marked the beginning of access outside the U.S. and now enables the collection of post-market real-world data. Together with evidence from our U.S. pivotal trial, these data will support broader adoption. As we work to complete the U.S. study and pursue FDA approval, we are building toward expanded access to this revolutionary option for women globally.”
FemBloc is a first-of-its-kind solution for permanent birth control designed to be delivered in the OB/GYN office, addressing a significant unmet need in women’s reproductive health. The technology combines a patented delivery system with a separately patented blended polymer that is placed into both fallopian tubes, safely degrades and forms natural scar tissue for permanent occlusion. Unlike surgical sterilization, FemBloc requires no anesthesia, incisions or recovery time, offering women a more convenient and affordable alternative while avoiding risks associated with surgery. Learn more at www.FemBloc.com.
About the FINALE Pivotal 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 study evaluating the safety and effectiveness of FemBloc, a novel, non-surgical approach to permanent birth control for women. Enrollment of an initial roll-in cohort of 50 women was completed to assess preliminary safety. These data, together with data from prior IDE-approved studies, supported U.S. Food and Drug Administration (FDA) approval to continue enrolling the remaining study participants. The primary endpoint is pregnancy rate, assessed after 401 women have relied on FemBloc for one year, with an interim analysis planned after 300 women complete one year of reliance. Under the FDA-approved protocol, the Company will submit for FDA approval based on the one-year data, with annual follow-up continuing for five years. For more information, visit www.FemBloc.com.
About Femasys Inc.
Femasys is a leading biomedical innovator developing transformative fertility and non-surgical permanent birth control solutions designed to improve the standard of care, expand access, and reduce costs for women worldwide. The Company is focused on commercializing its fertility portfolio, led by FemaSeed® Intratubal Insemination, together with complementary diagnostic and sperm preparation products, in the U.S. and key international markets. Femasys is also advancing FemBloc®, its non-surgical, in-office permanent birth control solution, toward U.S. FDA approval through the ongoing FINALE pivotal trial (NCT05977751). FemBloc received regulatory approvals in Europe, the UK and New Zealand in 2025, supporting commercialization through strategic partnerships in select international markets. Femasys’ portfolio is supported by broad intellectual property protection and clinical data demonstrating favorable safety, encouraging effectiveness results, and high patient and practitioner satisfaction.
Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.
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, 2025, 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:
IR@femasys.com
Media@femasys.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How many sites are enrolling in Femasys' FemBloc FINALE trial?
The FemBloc FINALE trial now has twelve actively enrolling sites across the United States, double the previous number. The network includes academic centers and private clinical practices, with Baylor Research Institute and Columbia University Medical Center joining the study.
What is the primary endpoint of Femasys' FemBloc FINALE trial?
The primary endpoint is pregnancy rate, assessed after 401 women have relied on FemBloc for one year. An interim analysis is planned after 300 women complete one year of reliance. Femasys plans to submit for FDA approval based on the one-year data.
Does Femasys' FemBloc FINALE trial have a control group?
FINALE is a single-arm study, meaning it does not include a separate comparison group. It is also prospective, multi-center and open-label, and evaluates FemBloc's safety and effectiveness for permanent birth control.