- Femasys Inc. announced the commencement of a **post-market surveillance (PMS) clinical study** for its **CE-marked FemBloc Permanent Birth Control** in Europe.  **[1339005_e74f2ca21d7440428850aed15f34ae64_0]** 
- This study is a key component of the company's European commercialization strategy, aiming to generate **real-world data** to support broader physician adoption and reimbursement, while ensuring compliance with **EU Medical Device Regulation (MDR)**.  **[1339005_e74f2ca21d7440428850aed15f34ae64_0]** 
- FemBloc, a **first-of-its-kind non-surgical solution** for permanent birth control, received full regulatory approval in Europe in **June 2025**, the UK in **August 2025**, and New Zealand in **September 2025**.  **[1339005_e74f2ca21d7440428850aed15f34ae64_0]** **[1339005_e74f2ca21d7440428850aed15f34ae64_1]**

Femasys Initiates Post-Market Surveillance Study for FemBloc in Europe

- **Femasys Inc.** will exhibit its fertility solutions, including **FemaSeed® Intratubal Insemination**, at the **ASRM 2025 Scientific Congress & Expo** from **October 25-29** in San Antonio, Texas.  **[1339005_ade0cdc09b8e4012a59230bd513844b4_0]** 
- **FemaSeed** is a next-generation artificial insemination solution that achieved **more than double the pregnancy rates of IUI** in cases of low male sperm count and is authorized for use in the U.S., Europe, UK, Canada, Israel, Australia, and New Zealand.  **[1339005_ade0cdc09b8e4012a59230bd513844b4_0]** 
- The **FemaSeed** Intratubal Insemination portfolio has expanded to include kits (FemSperm™ Setup, Prep, and Analysis) that enable gynecologists to perform sperm preparation and offer the procedure directly within their practices.  **[1339005_ade0cdc09b8e4012a59230bd513844b4_0]** 
- The company's **FemBloc®** permanent birth control received full regulatory approval in Europe in **June 2025**, the UK in **August 2025**, and New Zealand in **September 2025**, with a U.S. FDA approval trial currently ongoing.  **[1339005_ade0cdc09b8e4012a59230bd513844b4_1]**

Femasys to Exhibit at ASRM 2025 Scientific Congress & Expo

- Femasys Inc. announced the introduction of its **FemSperm Insemination Prep Kit**, designed to fully enable gynecologists to perform FemaSeed Intratubal Insemination directly in their offices.  **[1339005_5d7ea6a8e67341b99c60c4c697b053a6_0]** 
- This offering marks a key milestone in Femasys' commercialization strategy for the FemaSeed platform, supporting entry into the large, underserved fertility market.  **[1339005_5d7ea6a8e67341b99c60c4c697b053a6_0]** 
- The company aims to make fertility care more accessible by allowing gynecologists to offer FemaSeed within their practices, addressing an estimated **10 million U.S. women** facing infertility.  **[1339005_5d7ea6a8e67341b99c60c4c697b053a6_0]** 
- FemaSeed, a next-generation artificial insemination solution, achieved **more than double the pregnancy rates of IUI** in its pivotal trial for cases of low male sperm count.  **[1339005_5d7ea6a8e67341b99c60c4c697b053a6_0]**

Femasys Introduces FemSperm Insemination Prep Kit

- Femasys Inc. closed **$8 million in financing** on **September 2, 2025**, with continued support from existing investors, including its largest shareholders.  **[1339005_7faf21424ab440b0aa2c826f38511289_0]** 
- This funding is intended to accelerate commercialization efforts for its **FemaSeed®** and **FemBloc®** offerings, aiming for **meaningful revenue growth**.  **[1339005_7faf21424ab440b0aa2c826f38511289_0]** **[1339005_7faf21424ab440b0aa2c826f38511289_1]** 
- Recent company milestones in the second half of 2025 include regulatory approvals for **FemBloc** in Europe (June 25) and the UK (August 20), a **$400,000 USD order for FemBloc in Spain** (August 6), and regulatory approval for **FemaSeed** in Australia and New Zealand (July 1).  **[1339005_7faf21424ab440b0aa2c826f38511289_1]**

Femasys Closes $8 Million Financing Round

- Femasys Inc. entered into an underwriting agreement on **August 25, 2025**, for a public offering of **10,434,586 shares of common stock**, **11,750,000 pre-funded warrants**, and **22,184,586 common warrants**, with expected gross proceeds of **$8.0 million**.  **[1339005_0001140361-25-032806_ny20053452x9_ex1-1.htm:0]** **[1339005_0001140361-25-032806_ny20053452x9_8k.htm:1]** 
- The combined public offering price for common stock and accompanying common warrants is **$0.36**, while pre-funded warrants and accompanying common warrants are priced at **$0.3599**.  **[1339005_0001140361-25-032806_ny20053452x9_8k.htm:1]** 
- The company intends to use the net proceeds for **expansion of commercial efforts, product development, general corporate purposes, capital expenditures, working capital, and general and administrative expenses**.  **[1339005_0001140361-25-032806_ny20053452x9_8k.htm:1]** 
- Additionally, underwriters will receive warrants to purchase **443,692 shares of Common Stock** at an exercise price of **$0.45**, exercisable six months after closing and expiring on **August 27, 2030**.  **[1339005_0001140361-25-032806_ny20053452x9_8k.htm:1]** **[1339005_0001140361-25-032806_ny20053452x9_ex4-1.htm:1]**

FEMASYS (FEMY)