Femasys Announces FDA Approval of Modular PMA Submission Approach for FemBloc®
Femasys (NASDAQ:FEMY) announced that the U.S. FDA has approved its modular premarket approval (PMA) submission approach for FemBloc, the company’s investigational non-surgical permanent birth control technology in the United States.
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 (NASDAQ:FEMY) announced that the U.S. FDA has approved its modular premarket approval (PMA) submission approach for FemBloc, the company’s investigational non-surgical permanent birth control technology in the United States.
According to Femasys, the modular PMA allows FDA to review key components of the FemBloc submission before final clinical data are available, creating a clearer regulatory framework toward potential U.S. approval. FemBloc is already approved for marketing in Europe and select international markets. In parallel, Femasys is building a U.S. commercial team and expanding distribution of its fertility portfolio from infertility specialists to OB/GYNs, with the intention that this team will ultimately also support FemBloc.
FemBloc is designed as an office-based, first-of-its-kind permanent birth control solution that uses a patented delivery system and polymer placed into both fallopian tubes, which degrades and promotes natural scar tissue for permanent occlusion, without anesthesia, incisions, or recovery time.
Positive
- FDA-approved modular PMA pathway creates structured route toward potential U.S. approval for FemBloc
- FemBloc already approved for marketing in Europe and select international markets
- Commercial build-out of U.S. team to expand fertility portfolio access to OB/GYNs
- Office-based, non-surgical technology offers permanent birth control without anesthesia or incisions
Negative
- FemBloc remains investigational in the United States, with final clinical data and full PMA still pending
- U.S. commercialization timing for FemBloc depends on successful completion and review of the remaining PMA modules
Details
Market move: FEMY +23.18% in the Aug 19 session. FDA modular PMA approval
On Aug 19, the day this news came out, FEMY closed 23.18% above the previous close. Argus tracked a peak move of +46.4% during that session. Argus tracked a trough of -15.2% from its starting point during tracking. Our momentum scanner recorded 82 alerts for this stock that day. Relative volume reached 5984.4x the daily average during tracking.
Data tracked by StockTitan Argus for the Aug 19 session.
Previous Fda approval Reports
-
FDA 510(k) clearance for next-generation FemVue diagnostic device
-
FDA IDE approval advanced enrollment in Part B of the pivotal trial
-
FDA 510(k) clearance supported marketing of FemChec diagnostic solution
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
premarket approval application regulatory
permanent occlusion medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
-- Modular PMA pathway advances FemBloc toward potential U.S. approval while Femasys builds commercial infrastructure across its reproductive health portfolio --
ATLANTA, Aug. 19, 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 the U.S. Food and Drug Administration has approved the Company’s modular premarket approval application (PMA) pathway for FemBloc, its investigational non-surgical permanent birth control technology in the United States. FemBloc is approved for marketing in Europe and other select international markets.
“FDA approval of the modular PMA pathway provides a clear and efficient framework for advancing FemBloc toward U.S. approval, allowing key components of the submission to be reviewed by FDA in advance of the final clinical data,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys. “This approach enables us to make meaningful regulatory progress as the clinical program advances. In parallel, we are building a U.S. commercial team as we broaden commercialization of our fertility portfolio beyond infertility specialists to OB/GYNs, helping bring fertility care earlier in the patient journey. This same team is intended to ultimately support FemBloc, creating an efficient commercial foundation for expanding access to transformative reproductive health technologies through the OB/GYN setting.”
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 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.