Femasys Announces FemBloc® Permanent Birth Control Has Achieved MDSAP Certification, Advancing Global Market Access
Rhea-AI Summary
Femasys (NASDAQ: FEMY) announced that its FemBloc permanent birth control system achieved MDSAP certification on Feb. 26, 2026, enabling accelerated regulatory and commercial execution across the United States, Canada, Japan, Australia, and Brazil. The certification supports pivotal trial readiness toward a future PMA submission and strengthens manufacturing credibility for global expansion.
Positive
- MDSAP certification expands market access to US, Canada, Japan, Australia, Brazil
- Supports pivotal clinical trial readiness toward PMA submission
- Reinforces U.S.-based manufacturing credibility and operational scalability
- Aligns FemBloc with the company's existing MDSAP-certified product portfolio
Negative
- FemBloc remains premarket; PMA submission not yet filed for U.S. approval
- Commercial availability in major markets remains contingent on trial and regulatory outcomes
News Market Reaction – FEMY
On the day this news was published, FEMY declined 1.12%, reflecting a mild negative market reaction. Argus tracked a trough of -10.0% from its starting point during tracking. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $374K from the company's valuation, bringing the market cap to $33M at that time.
Data tracked by StockTitan Argus on the day of publication.
Market Reality Check
Peers on Argus
FEMY is up 3.6% while peers are mixed: EKSO (-4.84%), MHUA (-27.18%), LUCY (+4.46%), HBIO (+5.91%), BNGO (0%). This points to a stock-specific reaction.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 23 | Reimbursement coding | Positive | +1.6% | New AMA Category III CPT code approved for FemaSeed intratubal insemination. |
| Feb 03 | Commercial expansion | Positive | +1.4% | Expanded European footprint via Swiss distribution for FemBloc, FemaSeed and portfolio. |
| Jan 14 | Nasdaq compliance | Negative | +17.8% | Nasdaq granted 180‑day extension to regain $1.00 bid price, with reverse split option. |
| Jan 13 | Access partnership | Positive | -1.5% | Partnership with Refuah Health Center to expand first‑line access to FemaSeed. |
| Dec 18 | Device clearance | Positive | +4.1% | U.S. FDA 510(k) clearance for next‑generation FemVue diagnostic device. |
Recent positive operational and regulatory news has often seen modest positive reactions, but there are instances of divergence, including a sharp rise on a Nasdaq compliance update and a pullback on a commercial partnership.
Over the past six months, Femasys reported several milestones, including FDA 510(k) clearance for its next‑generation FemVue device on Dec 18, 2025 and European commercial expansion for FemBloc and FemaSeed on Feb 3, 2026. It also secured an AMA Category III CPT code for FemaSeed effective Jan 1, 2027, supporting reimbursement. Separately, Nasdaq granted a 180‑day extension to regain the $1.00 bid price, with potential reverse split actions. Today’s MDSAP certification for FemBloc fits this pattern of regulatory and commercial groundwork across the portfolio.
Regulatory & Risk Context
The company has an active S-3 shelf registration dated 2025-07-03, expiring on 2028-07-03. It has at least one related usage event, reflected by a 424B3 prospectus filed on 2026-01-09. Specific capacity and remaining availability were not provided in this context.
Market Pulse Summary
This announcement highlights MDSAP certification for FemBloc, which supports regulatory and commercial execution across markets including the U.S., Canada, Japan, Australia, and Brazil. It complements prior milestones such as FDA 510(k) clearance for FemVue and expanded European distribution for FemBloc and FemaSeed. Investors may watch how this certification supports the pivotal trial toward PMA submission, the pace of international uptake, and any capital-markets actions linked to the existing shelf registration and Nasdaq bid-price compliance timeline.
Key Terms
medical device single audit program (mdsap) regulatory
mdsap regulatory
pivotal clinical trial medical
pma submission regulatory
fallopian tubes medical
AI-generated analysis. Not financial advice.
-- 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
What does the Feb. 26, 2026 MDSAP certification mean for Femasys (FEMY)?
Will MDSAP certification allow immediate U.S. sales of FemBloc (FEMY)?
How does MDSAP certification affect FemBloc's international commercialization for FEMY?
Does MDSAP certification change FemBloc's clinical or safety profile (FEMY)?
How might MDSAP certification influence Femasys' partnership opportunities (FEMY)?
