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 Inc. (FEMY) has achieved a significant milestone with the CE mark certification for its FemBloc® delivery system, marking the world's first regulatory approval for non-surgical female permanent birth control under European Union Medical Device Regulation (EU MDR).
The company has also completed an expedited G12 Special MDR Audit for the FemBloc blended polymer, a important component of the permanent birth control system. The Notified Body has recommended CE mark approval, pending final European Medical Agency (EMA) review, with potential approval anticipated by mid-2025.
FemBloc represents a revolutionary alternative to traditional surgical permanent contraception, offering a safer and more accessible option. The company is preparing for a potential market launch in select European countries while continuing enrollment in their FDA IDE approved final pivotal clinical trial for U.S. approval.
Femasys (NASDAQ: FEMY) has announced the publication of positive clinical trial results for FemBloc®, its permanent birth control solution, in the Journal of Gynecology & Reproductive Medicine. The prospective, multi-center trials demonstrated compelling effectiveness and five-year safety data for the in-office therapeutic product.
The trials showed high satisfaction rates among both patients and practitioners, supporting FemBloc's potential as a non-surgical alternative to traditional sterilization procedures. The peer-reviewed publication represents a significant milestone in Femasys's mission to provide safer, more accessible permanent contraception options.
Femasys Inc. (NASDAQ: FEMY) has received regulatory approvals from the UK's Medicines & Healthcare products Regulatory Agency (MHRA) for three products: FemaSeed®, an intratubal insemination product for female infertility treatment, FemVue® for tubal evaluation, and FemCerv® for cervical cancer detection.
These UK approvals follow previous clearances and approvals in the United States, Europe, Canada, and Israel, marking an important expansion of Femasys' global market presence. The company focuses on providing innovative, accessible in-office therapeutic and diagnostic solutions for women's health needs.
Femasys Inc. (FEMY) has received regulatory approvals from Israel's Medical Device Division (AMAR) for three products: FemaSeed®, an intratubal insemination product for female infertility treatment, along with two diagnostic devices - FemVue® for tubal evaluation and FemCerv® for cervical cancer detection.
This approval follows FemaSeed's previous regulatory milestones, including FDA clearance in September 2023 and EU CE mark approval in June 2024. The company aims to provide accessible, lower-cost options for women's healthcare through in-office therapeutic and diagnostic products. Femasys is focusing on commercial execution in the U.S. and select markets as it continues expanding its product availability globally.
Femasys (NASDAQ: FEMY) announces the European Patent Office's intention to grant two EU Patent Applications (24170531.8 and 18751753.7) for its FemBloc permanent birth control technology. The patents, expiring in 2039 and 2038 respectively, cover essential components of FemBloc's fallopian tube occlusion system, which provides a non-surgical alternative to traditional sterilization.
The company plans to pursue additional patent applications to strengthen its portfolio, which includes other products like FemaSeed, FemVue, FemCath, and FemCerv. This patent expansion in Europe precedes commercial availability and supports Femasys' mission to provide accessible women's health technologies globally.
Femasys (NASDAQ: FEMY) has received a Notice of Allowance from the USPTO for U.S. Patent Application 18/443,798, strengthening its intellectual property position for FemaSeed® Intratubal Insemination, a therapeutic product for female infertility treatment. The new patent, expected to expire no earlier than 2044, adds to Femasys' portfolio of over 180 patents globally.
The company plans to pursue additional patent applications to enhance protection for FemaSeed® and other products, including FemBloc® permanent birth control and diagnostic products FemVue®, FemCath®, and FemCerv®. FemaSeed is currently being marketed in the United States and Spain as a solution for women and couples seeking pregnancy assistance.
Femasys (NASDAQ: FEMY) announces a partnership with HRC Fertility, a major fertility services provider in the Western U.S., to offer FemaSeed Intratubal Insemination treatment at California locations. FemaSeed is a first-line fertility treatment that delivers sperm directly into the fallopian tube, showing higher efficacy compared to traditional intrauterine insemination for low male sperm count. The treatment offers a cost-effective option before pursuing IVF and ICSI procedures.
Femasys Inc. (NASDAQ: FEMY) announced the publication of positive data from its pivotal trial of FemaSeed® intratubal insemination (ITI) in the Journal of Gynecology & Reproductive Medicine. The trial demonstrated safety and effectiveness of FemaSeed ITI, with high satisfaction ratings from practitioners and patients. The study showed pregnancy rates more than double compared to intrauterine insemination (IUI) for low male sperm count cases, which affects approximately 50% of infertile couples. FemaSeed is positioned as a less invasive and more affordable alternative to in vitro fertilization (IVF) for infertility treatment.
Femasys (NASDAQ: FEMY) reported Q3 2024 financial results with sales increasing 127.1% to $554,908, driven by FemaSeed and FemVue products. The company announced partnerships with Boston IVF and strategic distribution deals in Spain expected to generate over $1.3 million next year. Net loss widened to $5.4 million ($0.24 per share) compared to $4.0 million ($0.26 per share) in Q3 2023. Cash position stood at $7.6 million, expected to fund operations into July 2025. The company received FDA 510(k) clearance for FemChec and CE Mark certification for FemVue MINI.
Femasys (NASDAQ: FEMY) announces its participation in the AAGL 2024 Annual Global Conference, scheduled for November 16-19 in New Orleans, Louisiana. The biomedical company will exhibit at booth #902, showcasing its late-stage clinical development product FemBloc® along with other commercially available solutions. The conference focuses on gynecological surgery and provides Femasys an opportunity to present its portfolio of in-office, accessible therapeutic and diagnostic products designed to address unmet needs in women's healthcare.
FAQ
What is the current stock price of FEMASYS (FEMY)?
What is the market cap of FEMASYS (FEMY)?
