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. (NASDAQ: FEMY) generates frequent news flow as a biomedical company focused on women’s reproductive health, fertility treatment and non-surgical permanent birth control. News updates commonly highlight progress across its product portfolio, including FemaSeed Intratubal Insemination, FemVue and FemVue Controlled diagnostic devices, FemBloc permanent birth control, and the FemChec diagnostic product.
Investors following FEMY news can expect coverage of regulatory milestones, such as U.S. FDA 510(k) clearance for FemVue Controlled and Investigational Device Exemption approval to advance the final phase of the FINALE pivotal trial for FemBloc. Company announcements also report international approvals for FemBloc in Europe, the UK and New Zealand, as well as the launch of post-market surveillance studies under EU Medical Device Regulation.
Femasys news releases frequently describe commercialization developments, including partnerships with distributors like Kebomed to expand FemBloc access in France and the Benelux region, initial commercial orders in European markets, and collaborations with healthcare providers such as Refuah Health Center to offer FemaSeed as a first-line infertility treatment in community-based care. Financial and capital markets updates, including quarterly results, underwritten offerings, and private placements of senior secured convertible notes and warrants, are also disclosed through press releases and related SEC filings.
This FEMY news page aggregates these updates in one place, making it easier to track clinical progress, regulatory events, commercialization agreements, and listing-related notices from Nasdaq. Readers can use this feed to review how Femasys is executing on its women’s health strategy and how new information may relate to the company’s fertility and permanent birth control portfolio over time.
Femasys (NASDAQ: FEMY), a biomedical company focused on women's health, has announced plans for a public offering of common stock alongside a concurrent private placement. The company will grant underwriters a 30-day option to purchase up to an additional 15% of shares from the public offering. Current institutional stockholders, directors, and officers have shown interest in participating in the private placement.
Jones will serve as the sole book-running manager for the public offering and placement agent for the private placement. Femasys plans to use the proceeds for commercial expansion, product development, corporate purposes, capital expenditures, and working capital. The public offering will be made through a previously filed S-3 Registration Statement, while the private placement will rely on Securities Act exemptions.
Femasys Inc. (NASDAQ: FEMY) reported financial results for 2024 and provided corporate updates. Key highlights include FemBloc® permanent birth control system approval in Europe and new distribution partnerships in Spain. The company's sales increased 52.0% to $1.63 million in 2024, while net loss widened to $18.82 million ($0.85 per share).
Notable achievements include partnerships with CNY Fertility, HRC Fertility, and Boston IVF for FemaSeed® distribution, along with UK and Israeli regulatory approvals. R&D expenses rose 14.0% to $8.22 million. The company ended 2024 with $3.5 million in cash and raised an additional $5.4 million post-year-end, expecting to fund operations into Q3 2025.
Femasys (NASDAQ: FEMY) has announced a strategic partnership with CNY Fertility, a national provider of fertility services, to offer its FemaSeed intratubal insemination product across CNY's network of 11 locations. The partnership aims to expand access and market share for Femasys's first-line infertility treatment option.
CNY Fertility, recognized as a prominent infertility group in the United States, will integrate FemaSeed into their comprehensive fertility solutions portfolio. This collaboration aligns with CNY Fertility's mission to provide affordable, high-quality fertility treatments while expanding treatment options for patients seeking to grow their families.
Femasys Inc. (FEMY) has secured its first global distribution partnerships for FemBloc®, a non-surgical permanent birth control solution, in Spain. The company has partnered with Comercial Medico Quirurigca, SA (CMQ) for northern Spain and Durgalab for the southern region.
These partnerships represent Femasys's first EU distributors and mark the initial global commercialization of FemBloc®. Both distribution partners have previous experience with Conceptus Essure product, positioning them strategically for marketing FemBloc® as a new advancement in non-surgical permanent birth control.
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.