Welcome to our dedicated page for FEMASYS news (Ticker: FEMY), a resource for investors and traders seeking the latest updates and insights on FEMASYS stock.
Femasys Inc (FEMY) delivers innovative solutions in women's healthcare through minimally invasive diagnostic tools and therapeutic devices. This news hub provides investors and industry observers with timely updates on corporate developments, regulatory milestones, and clinical advancements.
Access comprehensive coverage of FEMY's progress in fertility treatments, non-surgical birth control technologies, and companion diagnostics. Our curated news collection features official press releases, partnership announcements, and product clearance updates from global health authorities.
Key focus areas include FDA regulatory developments, international market expansions, and research breakthroughs. All content is sourced directly from company communications and verified financial channels to ensure accuracy and compliance with disclosure standards.
Bookmark this page for streamlined tracking of Femasys' biomedical innovations and corporate announcements. For complete investment analysis, combine these updates with SEC filings and market performance data available through Stock Titan's research tools.
Femasys (NASDAQ: FEMY) received U.S. FDA Investigational Device Exemption (IDE) approval to continue enrollment in Part B of the FINALE pivotal trial for FemBloc, advancing toward potential U.S. Pre-Market Approval (PMA).
The company also closed a $12 million senior secured convertible note financing with accompanying warrants that could produce up to $58 million in total proceeds if all warrants are exercised for cash. Notes bear 8.5% interest, 10-year maturity, and convert into up to 16,378,563 shares at $0.73 per share. Warrants exercisable at $0.81, $0.92, and $1.10 could add up to $46 million if exercised.
Femasys (NASDAQ: FEMY) announced the initiation of a post-market surveillance (PMS) clinical study for its CE-marked FemBloc Permanent Birth Control in Europe on October 22, 2025.
The study is conducted under the EU Medical Device Regulation (EU MDR 2017/745, Annex XIV Part B), has approval from multiple Ethics Committees, and follows ISO 14155:2020 Good Clinical Practice and applicable national rules. FemBloc is described as a non-surgical permanent birth control using a biodegradable polymer delivery to occlude fallopian tubes without anesthesia, incisions, or recovery time, positioned to support physician adoption and reimbursement across Europe.
Femasys (NASDAQ: FEMY) will exhibit at the ASRM 2025 Scientific Congress & Expo in San Antonio, Oct 25–29, 2025, at booth #619. The company will showcase FemaSeed Intratubal Insemination (ITI), described as a next‑generation artificial insemination solution that delivers sperm directly to the fallopian tube.
The release highlights a pivotal trial where FemaSeed achieved >2x pregnancy rates versus IUI in low male sperm count cases, notes authorization for use in the U.S., Europe, UK, Canada, Israel, Australia and New Zealand, and announces an expanded ITI portfolio (FemSperm Setup Kit, FemSperm Prep Kit, FemSperm Analysis Kit). ASRM 2025 expects over 5,500 reproductive‑medicine professionals.
Femasys Inc. (NASDAQ: FEMY) has announced a strategic partnership with Kebomed to commercialize its FemBloc Permanent Birth Control solution in France and Benelux countries. This partnership follows FemBloc's recent CE mark approval and targets France as the largest European market opportunity.
FemBloc is a revolutionary non-surgical permanent birth control solution that uses a proprietary polymer delivery system to create natural scar tissue in fallopian tubes. The technology eliminates risks associated with surgical sterilization, including anesthesia complications and infection, while offering a more cost-effective and accessible option for women.
Femasys Inc. (NASDAQ: FEMY) has announced a strategic partnership with Medical Electronic Systems LLC (MES) to launch the FemSperm Analysis Kit. This addition completes the FemSperm product family, which includes the Setup Kit and Insemination Prep Kit.
The partnership enables gynecologists to perform complete in-office sperm preparation and analysis for FemaSeed Intratubal Insemination, a first-step infertility treatment. FemaSeed has demonstrated more than double the pregnancy rates of intrauterine insemination (IUI) in cases of low male sperm count in its pivotal trial.
The solution is currently authorized for use in multiple markets including the U.S., Europe, UK, Canada, Israel, Australia and New Zealand, offering a more accessible and cost-effective alternative to traditional fertility treatments.
Femasys Inc. (NASDAQ: FEMY) has launched its new FemSperm Insemination Prep Kit, completing the sperm preparation component of their FemSperm product line. This development enables gynecologists to perform FemaSeed Intratubal Insemination procedures directly in their offices.
The kit works in conjunction with the FemSperm Setup kit to optimize sperm preparation for FemaSeed procedures. This innovation targets the estimated 10 million U.S. women facing infertility, offering a more accessible fertility treatment option through gynecologist offices, as an alternative to traditional IVF centers which only perform about 200,000 transfer cycles annually.
FemaSeed has demonstrated superior efficacy, achieving more than double the pregnancy rates of intrauterine insemination (IUI) in cases of low male sperm count during its pivotal trial. The treatment is currently authorized in multiple markets including the U.S., Europe, UK, Canada, Israel, Australia, and New Zealand.
Femasys (NASDAQ: FEMY) has secured regulatory approval from New Zealand's MEDSAFE for FemBloc®, its innovative non-surgical permanent birth control solution. This milestone follows recent approvals in Europe (CE Mark) and the UK, marking the company's entry into the Asia-Pacific region.
FemBloc® is a first-of-its-kind technology that uses a proprietary blended polymer delivery system to create permanent fallopian tube occlusion through natural scar tissue formation. The solution eliminates risks associated with surgical sterilization, including anesthesia complications and infection, while offering a more cost-effective and accessible option for women seeking permanent birth control.
Femasys (NASDAQ: FEMY) has secured $8 million in financing to accelerate the commercialization of its innovative women's health products. The funding, backed by existing investors including the company's largest shareholders, will support the expansion of their FemaSeed® fertility treatment and FemBloc® non-surgical permanent birth control solutions.
The company has achieved significant milestones in 2025, including regulatory approvals for FemBloc in Europe and the UK, introduction of the FemSperm™ Setup Kit, and a $400,000 commercial order from Spain. Additional achievements include regulatory approvals for FemaSeed in Australia and New Zealand, and a partnership with Carolinas Fertility Institute.
Femasys (NASDAQ: FEMY), a biomedical company focused on women's health, has announced the pricing of an $8.0 million underwritten public offering. The offering includes 10,434,586 shares of common stock and pre-funded warrants for up to 11,750,000 shares, along with common warrants to purchase up to 22,184,586 shares.
The combined offering price is set at $0.36 per share with accompanying warrants (except for certain officers purchasing at $0.5151). The warrants will be immediately exercisable and expire in five years. The company plans to use the proceeds for commercial expansion, product development, corporate purposes, and working capital. The offering is expected to close around August 27, 2025.
Femasys (NASDAQ: FEMY) has introduced the FemSperm Setup Kit, the first product in a planned series designed to enable gynecologists to perform FemaSeed Intratubal Insemination in their offices. The kit includes specialized components like a pre-configured centrifuge for optimizing sperm preparation.
FemaSeed is a next-generation artificial insemination solution that delivers sperm directly to the fallopian tube. In pivotal trials, it demonstrated more than double the pregnancy rates compared to IUI in cases of low male sperm count. The treatment is currently authorized in multiple markets including the U.S., Europe, UK, Canada, Israel, Australia, and New Zealand.
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