FEMASYS INC Stock Price, News & Analysis

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.

Femasys (NASDAQ: FEMY) has appointed Kelley Nicholas as Chief Commercial Officer to lead its commercial strategy and drive revenue growth. Nicholas brings over 25 years of industry experience, including significant success at companies like NeuroPace, Hologic, Medtronic, and Baxter. In her new role, she will focus on expanding Femasys' presence in the U.S. infertility market and developing international partnerships across the company's portfolio of women's health products, including FemaSeed. Nicholas's previous achievements include accelerating revenue growth at NeuroPace and driving top-line growth across all business units at Hologic. As part of her appointment, Nicholas received an inducement option to purchase 100,000 shares of Femasys common stock, vesting over four years with 25% vesting annually.

Femasys (NASDAQ: FEMY) has announced a strategic partnership with Carolinas Fertility Institute (CFI) to offer FemaSeed, its intratubal insemination product, across CFI's network in North Carolina. CFI, recognized as one of America's top fertility clinics, will integrate FemaSeed as a first-line fertility treatment option. The partnership aims to provide patients with a less invasive and more cost-effective alternative to IVF during early stages of fertility treatment. CEO Kathy Lee-Sepsick highlighted the growing momentum behind FemaSeed, while CFI's Founder and Medical Director Dr. Tamer Yalcinkaya emphasized the alignment with their mission to deliver advanced yet affordable fertility care.

Femasys (NASDAQ: FEMY), a biomedical company focused on women's health, has announced a combined public offering and private placement to raise $4.5 million in gross proceeds. The public offering consists of 3.6 million shares at $0.85 per share, while the private placement includes 1.69 million shares priced at $0.85 for institutional investors and $1.02 for directors and officers. The underwriter has a 30-day option to purchase an additional 540,000 shares. The company plans to use the proceeds for commercial expansion, product development, corporate purposes, capital expenditures, and working capital. Both offerings are expected to close around June 2, 2025, with Jones serving as the sole book-running manager and placement agent.