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) operates in the medical device sector with a specialized focus on women's reproductive health technologies. As a company navigating the complex regulatory landscape for medical devices, Femasys generates news related to clinical developments, regulatory milestones, and commercial expansion activities.
Investors and healthcare professionals following FEMY can expect coverage of FDA and international regulatory decisions affecting the company's birth control and fertility treatment devices. Regulatory approvals and clinical study results represent significant catalysts for medical device companies of this size, making these announcements particularly relevant for stakeholders.
The company's news flow typically includes updates on product commercialization across different geographic markets, partnership announcements with distributors, and financing activities that support ongoing operations and clinical programs. Patent developments and intellectual property filings also feature in the company's disclosure activities.
Healthcare sector investors tracking Femasys will find news covering the company's progress in both the permanent contraception and fertility treatment markets. These two distinct but related therapeutic areas generate separate newsworthy developments as products advance through clinical evaluation and commercial launch phases.
Bookmark this page to follow Femasys's journey as a specialized women's health medical device company pursuing regulatory approvals and market expansion for its reproductive health product portfolio.
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.
Femasys Inc. (NASDAQ: FEMY) has secured MHRA approval for its FemBloc Permanent Birth Control in the United Kingdom, following its recent CE mark approval for Europe. This regulatory milestone validates the product's safety, quality, and effectiveness standards for the UK market.
FemBloc represents a revolutionary non-surgical permanent birth control solution that utilizes a patented delivery system to place a proprietary blended polymer in the fallopian tubes. The polymer naturally degrades and forms scar tissue for permanent occlusion, offering significant advantages over surgical sterilization by eliminating anesthesia risks, infection concerns, and recovery time.
The UK approval positions Femasys to pursue strategic partnerships for commercialization in one of Europe's largest healthcare markets, particularly through the National Health Service (NHS).
Femasys Inc. (NASDAQ: FEMY) reported Q2 2025 financial results with notable regulatory achievements and commercial expansion. Sales increased 84.8% to $409,268 in Q2 2025, driven by FemaSeed and FemVue products. The company secured significant milestones including EU approval for FemBloc, their non-surgical permanent birth control solution, with a $400,000 initial order from Spain.
The quarter saw regulatory approvals in Australia and New Zealand for FemaSeed and FemVue, alongside a new partnership with Carolinas Fertility Institute. However, Femasys reported a net loss of $4.6 million ($0.16 per share) and had $3.2 million in cash as of June 30, 2025, expected to fund operations only into early Q4 2025.
Femasys (NASDAQ: FEMY) has secured its first European commercial order for FemBloc, its revolutionary non-surgical permanent birth control solution, with a $400,000 USD order from Spain. The company has partnered with Comercial Medico Quirúrgica and Durgalab as distributors, leveraging their experience with similar women's health technologies.
FemBloc represents a breakthrough in permanent contraception, utilizing a proprietary polymer delivery system that creates natural scar tissue in the fallopian tubes. This non-surgical approach eliminates risks associated with traditional surgical sterilization, offering a safer, more accessible, and cost-effective alternative for women seeking permanent birth control.
Femasys (NASDAQ:FEMY) has secured regulatory approvals in Australia and New Zealand for two key products in its women's health portfolio. The approvals cover FemaSeed®, a first-line intratubal insemination treatment for infertility, and FemVue®, a diagnostic evaluation tool.
According to CEO Kathy Lee-Sepsick, these regulatory milestones represent significant progress in expanding global access to the company's innovative infertility solutions. The approvals are expected to create new commercial opportunities and support revenue growth while expanding Femasys's global market presence.
Femasys (NASDAQ:FEMY) has achieved a historic milestone with the European CE mark approval for its FemBloc® System, the world's first non-surgical permanent birth control solution. The Class III FemBloc blended polymer component received certification under EU MDR 2017/745, following the earlier approval of its delivery system component in March 2025.
The FemBloc System can now be marketed across the European Economic Area, including 27 EU member states and 3 European Free Trade Association countries. The company plans to launch commercial distribution initially in Spain through existing partners while pursuing additional country approvals and continuing its FDA IDE-approved pivotal trial for U.S. approval.
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