FEMYFDA Updates
Femasys Expands Fertility Care Portfolio in Europe with CE Mark Approval for FemHSG™ Catheter
Femasys Inc. has received CE Mark approval for its FemHSG Catheter, enhancing its fertility care portfolio in Europe. This catheter, designed for in-office fertility evaluations, works in conjunction with the FemVue device. The approval aims to improve access to timely and affordable fertility diagnosis and treatment for women. CEO Kathy Lee-Sepsick emphasized the importance of expanding in-office fertility services.
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Femasys Enables OB/GYNs to Deliver First-Line Fertility Treatment with Initial Commercial Use of FemaSeed® Complete
Femasys Inc. has launched FemaSeed as a first-line fertility treatment in OB/GYN practices, enabling in-office sperm preparation with FemSperm. This innovation addresses the significant gap in infertility care access, allowing earlier intervention at a lower cost. The approach aims to streamline fertility treatment, improving patient outcomes and satisfaction.
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Femasys Drives International Growth with Israeli Market Entry for Fertility Portfolio
Femasys Inc. has entered a strategic partnership with AMI Technologies to introduce its fertility portfolio in Israel. This collaboration aims to enhance market access for innovative treatments like FemaSeed and FemVue, leveraging AMI's established infrastructure and expertise. The partnership is part of Femasys's broader strategy to expand its global footprint in women's health.
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Femasys Announces Financial Results for Year Ended December 31, 2025 and Provides Corporate Update
Femasys Inc. reported its financial results for the year ending December 31, 2025, highlighting significant clinical and regulatory advancements. The company is actively enrolling patients in the FINALE pivotal trial for its FemBloc product, aiming for FDA approval. Additionally, Femasys is expanding its FemaSeed commercialization efforts in the U.S. market.
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Femasys Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - February 27, 2026
Femasys Inc. has announced the granting of stock options to two new non-executive employees as part of their inducement grants under Nasdaq Listing Rule 5635(c)(4). The options, totaling 185,000 shares, were granted at prices reflecting the stock's closing value. This move aims to attract talent while ensuring compliance with regulatory standards.
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Femasys Announces FemBloc® Permanent Birth Control Has Achieved MDSAP Certification, Advancing Global Market Access
Femasys Inc. announced that its FemBloc permanent birth control system has received MDSAP certification, facilitating regulatory and commercial execution in key global markets. This certification enhances the company's manufacturing credibility and operational scalability, supporting ongoing commercialization efforts. FemBloc is positioned as a non-surgical alternative to traditional sterilization, aiming to expand access to permanent contraception.
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Femasys Receives AMA CPT Editorial Panel Approval for New Category III CPT Code for FemaSeed Intratubal Insemination
Femasys Inc. has received approval from the AMA for a new Category III CPT code for its FemaSeed intratubal insemination procedure. This approval is expected to enhance reimbursement strategies and support broader adoption of the treatment, which has shown to significantly improve pregnancy rates compared to traditional methods. The new code will be effective from January 1, 2027.
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Femasys Expands European Commercial Footprint with Swiss Partner for FemBloc, FemaSeed, and Portfolio Products
Femasys Inc. has entered a strategic distribution partnership with OR Consulting to launch its product portfolio in Switzerland, including FemBloc and FemaSeed. This agreement is part of Femasys's broader European expansion strategy, which also includes recent market entries in Spain and France. The collaboration aims to enhance access to innovative women's health solutions across Europe.
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Femasys Granted 180-Day Extension by Nasdaq to Regain Compliance with Minimum Bid Price Requirement
Femasys Inc. has been granted a 180-day extension by Nasdaq to meet the minimum bid price requirement of $1.00 per share. The company must achieve this price for ten consecutive business days to maintain its listing. Femasys is committed to compliance and is monitoring its share price closely, with plans to take necessary actions if needed.
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Femasys Announces Partnership with Refuah Health Center to Expand First-Line Access to FemaSeed® in Community-Based Care
Femasys Inc. has partnered with Refuah Health Center to enhance access to its FemaSeed product, a first-line infertility treatment. This collaboration aims to improve the availability of FemaSeed in community-based fertility care, making it more accessible and cost-effective for patients. The partnership is expected to accelerate the adoption of FemaSeed, which has demonstrated superior pregnancy rates compared to traditional methods.
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