Femasys Announces FemBloc® Permanent Birth Control Has Achieved MDSAP Certification, Advancing Global Market Access
MWN-AI** Summary
Femasys Inc. (NASDAQ: FEMY), a pioneering biomedical company focused on enhancing women's reproductive health, announced that its FemBloc® permanent birth control system has achieved certification under the Medical Device Single Audit Program (MDSAP). This certification is a key milestone, enabling Femasys to enhance its regulatory and commercial efforts across significant global markets, including the U.S., Canada, Japan, Australia, and Brazil. The MDSAP certification signifies a high level of quality system maturity recognized by the FDA, and it serves to boost the company's readiness for its pivotal clinical trial aimed at PMA submission in the U.S.
FemBloc represents a novel, non-surgical option for permanent birth control, addressing the significant unmet needs of women seeking safe and convenient contraceptive methods. Unlike traditional surgical sterilization, which involves anesthesia and post-operative recovery, FemBloc employs a patented delivery system to introduce a proprietary polymer into the fallopian tubes, forming natural scar tissue to achieve permanent occlusion. This innovation intends to provide women with a safer, less complex, and more cost-effective solution to contraception, ultimately reducing the burden on healthcare systems.
Femasys's CEO, Kathy Lee-Sepsick, emphasized that the MDSAP certification aligns FemBloc with the company's established product portfolio and enhances its market scalability and strategic partnership potential. As permanent birth control options remain underutilized due to the risks and complexities of surgical methods, FemBloc seeks to broaden access to these services globally. With its strong focus on commercial execution and regulatory compliance, Femasys is positioning itself to capture a substantial market that remains largely underserved. Future commercialization plans involve strategic partnerships in selected international markets, advancing their mission to make non-surgical permanent birth control more accessible and effective for women around the world.
MWN-AI** Analysis
Femasys Inc. (NASDAQ: FEMY) has recently announced a significant advancement with its FemBloc® permanent birth control solution, achieving Medical Device Single Audit Program (MDSAP) certification. This milestone positions FemBloc to enhance its global market accessibility across key regions, including the United States, Canada, Japan, Australia, and Brazil, while aligning with the company's existing MDSAP-certified portfolio.
Investors should note that the MDSAP certification signifies a high-quality manufacturing standard recognized by multiple regulatory authorities, thereby reducing compliance risks and enhancing credibility. This progress indicates a robust infrastructure in place to facilitate Femasys' upcoming pivotal clinical trial and the expected Pre-Market Approval (PMA) submission to the FDA. The successful trial outcomes are pivotal, as they may shape the company's stock performance moving forward.
Furthermore, FemBloc addresses a substantial unmet need in women's reproductive health by providing a non-surgical alternative to traditional sterilization methods, which have been burdened by procedural complexities and risks. The ability to market such a product not only caters to women seeking permanent birth control but also has the potential to ease healthcare system burdens, which could appeal to a wider audience, including healthcare providers and payers.
The global market for permanent birth control remains significantly underserved and presents an opportunity for exceptional returns, especially as Femasys continues to develop strategic partnerships for commercialization in Europe and enhance scalability. Given these factors, investors should monitor Femasys closely, particularly as the company progresses towards significant regulatory milestones, providing a potentially lucrative entry point for those interested in biotech and women's health sectors.
In conclusion, Femasys demonstrates promising growth potential with FemBloc’s MDSAP certification as a catalyst, and stakeholders may find strategic opportunities as the company reiterates its commitment to enhancing global reproductive health.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
-- FemBloc becomes the latest Femasys product to achieve MDSAP certification, building on a proven track record of compliance --
ATLANTA, Feb. 26, 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 its FemBloc permanent birth control system has achieved certification under the Medical Device Single Audit Program (MDSAP). The MDSAP certification positions the Company to accelerate regulatory and commercial execution across key global markets, including the United States, Canada, Japan, Australia, and Brazil. In the U.S., FDA recognition of MDSAP reflects a high level of quality system maturity and supports regulatory readiness as the Company advances its pivotal clinical trial toward PMA submission. Internationally, the certification enhances manufacturing credibility and operational scalability, supporting ongoing commercialization in Europe and enabling more efficient market entry in additional high-value regions. Overall, MDSAP certification reduces regulatory risk, reinforces manufacturing readiness, and advances the Company’s global expansion strategy.
“Achieving MDSAP certification is a significant milestone for FemBloc and expands our pathway into key international markets,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. “This certification aligns FemBloc with our established, MDSAP-certified portfolio and reflects the strength of our U.S. based manufacturing platform. Importantly, it enhances our global scalability, supports future U.S. commercialization, and strengths our ability to pursue strategic partnerships as we target a substantial global market that remains both underserved and significantly underpenetrated.”
Permanent birth control is one of the most widely utilized contraceptive methods worldwide, yet current options remain surgical, requiring anesthesia, abdominal incisions, and post-procedure recovery, which introduce procedural risks and increase healthcare costs. FemBloc is a first-of-its-kind, non-surgical solution for permanent birth control designed to address this significant 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 risks and complexities associated with surgical sterilization, FemBloc provides women a safer, more convenient, and affordable option. FemBloc has the potential to expand access to permanent contraception while reducing the burden on healthcare systems globally. Learn more at 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
FAQ**
How will the MDSAP certification for FemBloc impact Femasys Inc. (FEMY) in terms of its regulatory readiness and market entry in key regions like the U.S. and Japan?
What are the anticipated clinical trial milestones for FemBloc as Femasys Inc. (FEMY) prepares for its PMA submission in the U.S. following MDSAP certification?
In what ways does Femasys Inc. (FEMY) plan to leverage its MDSAP-certified portfolio to form strategic partnerships for FemBloc’s commercialization in underserved markets?
How does the achievement of MDSAP certification for FemBloc enhance Femasys Inc. (FEMY)'s manufacturing credibility and operational scalability in international markets?
**MWN-AI FAQ is based on asking OpenAI questions about Femasys Inc. (NASDAQ: FEMY).
NASDAQ: FEMY
FEMY Trading
-0.81% G/L:
$0.5137 Last:
189,428 Volume:
$0.50 Open:
