Femasys Announces Partnership with Refuah Health Center to Expand First-Line Access to FemaSeed® in Community-Based Care
Rhea-AI Summary
Femasys (NASDAQ: FEMY) announced a partnership with Refuah Health Center on Jan 13, 2026 to offer FemaSeed as a first-line step in infertility treatment within community-based care.
The agreement aims to expand patient access, strengthen Femasys' commercial footprint in community fertility care, and accelerate adoption by leveraging Refuah's patient engagement and care model.
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News Market Reaction – FEMY
On the day this news was published, FEMY declined 1.53%, reflecting a mild negative market reaction. Argus tracked a peak move of +14.0% during that session. Our momentum scanner triggered 27 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $636K from the company's valuation, bringing the market cap to $41M at that time. Trading volume was above average at 1.7x the daily average, suggesting increased trading activity.
Data tracked by StockTitan Argus on the day of publication.
Market Reality Check
Peers on Argus
Peers show mixed moves: one notable gainer (EKSO +8.66%), one sharp decliner (MHUA -27.18%), others flat to down, suggesting stock-specific rather than broad sector dynamics.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 18 | Regulatory clearance | Positive | +4.1% | U.S. FDA 510(k) clearance for next-generation FemVue device. |
| Nov 14 | Earnings & update | Positive | +8.6% | 3Q 2025 results with growth, new approvals, partnerships, and financings. |
| Nov 10 | Commercial order | Positive | +0.0% | Initial ~$500,000 FemBloc order for France and Benelux expansion. |
| Nov 03 | Trial & financing | Positive | +3.1% | IDE approval to advance FemBloc trial plus $12M secured note financing. |
| Oct 22 | Clinical study start | Positive | -9.6% | EU post-market surveillance study launch for FemBloc permanent birth control. |
Recent regulatory, financing, and commercialization news skewed positive, with three events seeing price gains and two showing muted or negative reactions despite constructive updates.
Over the last few months, Femasys reported multiple milestones, including U.S. FDA 510(k) clearance for its next-generation FemVue device on Dec 18, 2025 and IDE approval to advance the final FemBloc pivotal trial phase paired with a $12 million financing on Nov 3, 2025. Commercially, the company expanded FemBloc in Europe via distribution orders and launched a post-market surveillance study under EU MDR. The new Refuah partnership extends this commercialization trend by broadening first-line FemaSeed access in community-based fertility care.
Regulatory & Risk Context
The company has an active S-3 shelf registration filed on 2025-07-03, expiring 2028-07-03. It is not yet effective and has one related 424B3 resale prospectus dated 2026-01-09, which registers shares from prior convertible notes and warrants rather than raising new capital.
Market Pulse Summary
This announcement adds another commercialization step for FemaSeed, embedding it as a first-line infertility treatment within a large community health provider. It follows earlier partnerships with major fertility networks and growing FemBloc distribution in Europe. Investors may track how quickly Refuah integrates FemaSeed, evidence of patient uptake, and any follow-on agreements with similar centers. Regulatory filings, including the active S-3 shelf and recent resale registration, remain relevant background when assessing longer-term capital structure and dilution risk.
Key Terms
ob/gyn medical
AI-generated analysis. Not financial advice.
Partnership enables broader adoption of FemaSeed through a trusted community health provider serving a large, engaged patient population
ATLANTA , Jan. 13, 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 a partnership with Refuah Health Center to offer FemaSeed as a first step in the infertility treatment process. The partnership is expected to strengthen Femasys’ commercial footprint in community-based fertility care by expanding patient access and supporting increased utilization of FemaSeed as a first-line approach.
“This partnership is an important step forward in expanding the commercial availability of FemaSeed within community-based fertility care,” said Kathy Lee-Sepsick, Chief Executive Officer of Femasys. “With Refuah’s trusted care model and strong patient engagement, we expect to accelerate adoption of FemaSeed by providing a more accessible, cost-effective, and patient-centered starting point for fertility treatment.”
“At Refuah, our focus is on providing patients with practical, evidence-based options that can streamline the fertility journey,” said Dr. Angela Silber, M.D., OB/GYN, at Refuah Health Center. “FemaSeed offers an accessible, patient-centered approach that may help many individuals begin care sooner and with less complexity, and we are pleased to make it available as an early step in treatment.”
About FemaSeed
FemaSeed® is a next-generation artificial insemination solution that enhances fertilization by precisely delivering sperm to the fallopian tube, the natural site of conception. Offering a safe, accessible, and cost-effective first-line treatment, FemaSeed provides a more effective alternative to intrauterine insemination (IUI). In the pivotal clinical trial (NCT0468847), it achieved over double the pregnancy rates of IUI in cases of low male sperm count.1 FemaSeed is an affordable, less invasive, lower-risk option before IVF. It is authorized for use in the U.S., Europe, UK, Canada, and Israel. Learn more at www.femaseed.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, a groundbreaking first-step infertility treatment and FemVue®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrates FemaSeed is over twice as effective as 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 of 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.
About Refuah Health
Refuah Health Center founded in 1992 is a Federally Qualified Community Health Center (FQHC) providing accessible, affordable, and high-quality comprehensive medical, dental, and behavioral health services to residents across New York's Hudson Valley. It is based on the belief that everyone should receive the highest quality care, regardless of income. Its mission is to eliminate social, economic, and cultural barriers to top-notch healthcare.
References
1 Liu, 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.
2 Liu, 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
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