Core Insights - Femasys Inc. has published positive data from initial clinical trials of FemBloc, a non-surgical permanent birth control method, demonstrating compelling effectiveness and five-year safety [1][3][4] - The pregnancy rate for FemBloc subjects was reported at 0%, significantly lower than the historical control goal of 6% for surgical sterilization [3] - The company aims to provide a safer, more accessible in-office alternative to traditional surgical sterilization, with high satisfaction reported from both patients and practitioners [2][4] Company Overview - Femasys is a biomedical innovator focused on women's health, developing a portfolio of minimally invasive therapeutic and diagnostic solutions [5] - The company’s products, including FemBloc, have received global regulatory approvals and are being commercialized in the U.S. and select countries [5] - FemBloc is positioned as a revolutionary non-surgical method for permanent contraception, utilizing a proprietary synthetic tissue adhesive to occlude the fallopian tubes [4][5] Clinical Trial Data - The publication titled "FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes" includes data from three clinical trials, confirming the effectiveness and safety of FemBloc [3][6] - No serious adverse events were reported among the 229 subjects, and the safety profile aligns with typical intrauterine transcervical procedures [3] - The pivotal clinical trial for U.S. approval (NCT05977751) is currently enrolling participants [4][5]

Core Insights - Femasys Inc. has received regulatory approvals from the Medicines & Healthcare products Regulatory Agency (MHRA) for its FemaSeed® Intratubal Insemination product and two diagnostic devices, FemVue® and FemCerv® [1][2] Company Overview - Femasys is a biomedical innovator focused on women's health, offering a range of therapeutic and diagnostic products that are accessible and designed to meet significant unmet needs globally [1][5] - The company is based in Atlanta and develops minimally invasive women's health solutions, with products manufactured in the U.S. [5] Product Details - **FemaSeed®**: An innovative artificial insemination product that enhances fertilization by delivering sperm directly into the fallopian tube, serving as a cost-effective first-line option for infertility treatment [2][5] - **FemVue®**: The first FDA-cleared product that uses natural saline and air contrast for real-time evaluation of fallopian tubes via ultrasound, essential for assessing the suitability for FemaSeed treatment [3][5] - **FemCerv®**: The first FDA-cleared product designed for pain-free collection of cervical samples for cancer detection [4][5] Market Expansion - The recent MHRA approvals mark a significant milestone for Femasys as it expands its market presence in the UK, following successful approvals in Europe [2]

2025年2月4日，美国生物医学公司Femasys Inc.（纳斯达克：FEMY）（2024年前三季度收入约为132万美元）宣布，其不孕症治疗产品 FemaSeed® 及两款诊断设备 FemVue® （输卵管评估）和 FemCerv® （宫颈癌检测）获得以色列卫生部医疗器械分部（AMAR）批准。这是继美国FDA（2023年9月）和欧盟CE（2024年6月） 后，Femasys全球化布局的又一关键进展。 # 产品介绍 1. FemaSeed® ：输卵管内定向人工授精系统 ● 操作流程： 超声定位优势卵泡位置； ○ 安全性：非侵入性，无麻醉需求； ○ 适用人群：男性少精症（精子数<500万/毫升）、不明原因不孕夫妇。 2. FemVue® ：输卵管超声评估系统 已获得以色列监管机构批准。 3. FemCerv® ：无痛宫颈组织取样器 ○ 无痛操作：减少患者不适，门诊即可完成。 ● 临床价值： 用于异常宫颈涂片后的阴道镜活检，降低漏诊率。 2024年第三季度在美国和欧洲(西班牙)开始商业化；2025年2月获得以色列监管机构批准。 ● 技术原理： 通过导管将精子直接注入输卵管（自然受孕部位），提升受精率。 ○ 导管定 ...

Core Insights - Femasys Inc. has received regulatory approval from the Israeli Medical Device Division for its FemaSeed product, which is designed for female infertility treatment, along with two diagnostic devices, FemVue and FemCerv [1][6]. Group 1: Product Overview - FemaSeed is an innovative artificial insemination method that enhances fertilization by delivering sperm directly into the fallopian tube, providing a cost-effective first-line option for couples seeking pregnancy [3][6]. - FemVue is the first FDA-cleared product that uses natural saline and air contrast for real-time evaluation of the fallopian tubes via ultrasound, essential for assessing the suitability of FemaSeed treatment [4][6]. - FemCerv is the only FDA-cleared product designed for pain-free collection of cervical samples for cancer detection, enhancing women's health diagnostics [5][6]. Group 2: Company Mission and Expansion - The company is committed to delivering technological advancements in women's health globally, with recent approvals in Israel expanding its market reach [2][6]. - Femasys focuses on commercial execution in the U.S. and select international markets to increase the availability of its product solutions [2][6]. Group 3: Regulatory Approvals and Market Position - FemaSeed has received U.S. FDA clearance and approvals in Europe, Canada, and Israel, positioning it as a leading option in the infertility treatment market [1][6]. - FemVue and FemCerv also hold multiple international approvals, reinforcing Femasys's strong regulatory standing and commitment to women's health solutions [6].

Company Overview - Femasys Inc. is a leading biomedical innovator focused on women's health, offering a range of therapeutic and diagnostic products [1][4] - The company is based in Atlanta and manufactures all its products in the U.S. [4] Patent Developments - The European Patent Office has issued notices of intention to grant for two EU Patent Applications, with anticipated expirations in 2039 and 2038 [1] - Femasys plans to pursue additional patent applications to strengthen its portfolio, particularly for FemBloc® permanent birth control and other products [1][2] Product Highlights - FemBloc® is a non-surgical permanent birth control method that uses a minimally invasive delivery system to block fallopian tubes [3] - The product is designed to be safe, accessible, and cost-effective compared to traditional surgical sterilization [3] - Femasys is currently enrolling participants in a pivotal clinical trial for U.S. approval of FemBloc® [3][4] Regulatory Approvals - Femasys has received global regulatory approvals for its products, including FemaSeed®, FemVue®, FemCerv®, and FemCath® [4] - FemBloc® is positioned as a late-stage product candidate, with significant benefits over surgical alternatives [4]

Patent and Intellectual Property - The resulting patent for FemaSeed is expected to expire in 2044 at the earliest, providing long-term protection for the product [1] - The company plans to continue prosecuting additional patent applications to enhance its existing portfolio, which includes FemaSeed, FemBloc, and other diagnostic products [1] - The USPTO issued a Notice of Allowance for U.S. Patent Application 18/443,798, strengthening the company's intellectual property position for FemaSeed Intratubal Insemination [3] - The company's global patent portfolio consists of over 180 patents, demonstrating a strong commitment to protecting innovation and commercial opportunities [7] Product Portfolio and Development - FemaSeed is an FDA-cleared infertility treatment designed to deliver sperm directly to the fallopian tube, offering a safe, accessible, and cost-effective alternative to IVF [8] - FemBloc is a late-stage product candidate for permanent birth control, intended to be a non-surgical, in-office option that is safer and less costly than surgical alternatives [4] - The company has developed complementary diagnostic products, including FemVue, FemCath, and FemCerv, which have received regulatory approvals in the U.S., Canada, Europe, and other territories [4] - FemaSeed has received regulatory approval in Canada (April 2023) and CE mark for Europe (June 2024), following its U.S. FDA clearance in September 2023 [8] Clinical Trials and Market Potential - A prospective, multi-center, pivotal clinical trial (NCT0468847) for FemaSeed concluded at the end of 2023, demonstrating its safety and efficacy as a treatment option for couples with male-factor or unexplained infertility [8] - Positive data from the clinical trial showed significantly higher efficacy for FemaSeed compared to historic intrauterine insemination for couples with low male sperm count [8] - The company's products are designed to address significant unmet needs of women worldwide, offering innovative and accessible therapeutic and diagnostic solutions [4] Strategic Vision and Commercialization - The company aims to expand its patent portfolio to protect its suite of products, including FemaSeed, FemBloc, and diagnostic solutions, ensuring better, lower-cost, and more accessible options for women [7] - Femasys has in-house manufacturing capabilities, making its diagnostic products commercial-ready and enabling the company to establish, maintain, and grow sales and revenues [4] - The company's business model focuses on advancing current product candidates, completing clinical trials, and successfully commercializing its products, including FemaSeed [9]

ATLANTA, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, announces the peer-reviewed publication of positive data from its pivotal trial of FemaSeed® intratubal insemination (ITI) in the Journal of Gynecology & Reproductive Medicine (JGRM), a leading peer-reviewed journal covering gynecology and repro ...

Femasys Inc. (FEMY) came out with a quarterly loss of $0.24 per share versus the Zacks Consensus Estimate of a loss of $0.20. This compares to loss of $0.26 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -20%. A quarter ago, it was expected that this company would post a loss of $0.18 per share when it actually produced a loss of $0.21, delivering a surprise of -16.67%.Over the last four quarters, the company has surpassed co ...

Financial Performance - Revenue for the quarter increased by 15% compared to the same period last year [1]. - Net profit margin improved to 12%, up from 10% in the previous quarter [2]. - Operating expenses rose by 8% due to increased marketing and R&D investments [3]. Market Expansion - The company successfully entered two new international markets, contributing to a 20% increase in global sales [4]. - A new distribution partnership was established in Europe, expected to boost market share by 5% in the next fiscal year [1]. - Expansion into the Asian market is underway, with plans to open three new offices by the end of the year [3]. Product Development - Launched three new products in the last quarter, which have already contributed to 10% of total revenue [2]. - R&D investment increased by 15% to accelerate the development of next-generation technologies [4]. - A new product line is scheduled for release in Q4, targeting the premium segment [1]. Operational Efficiency - Implemented new cost-saving measures that reduced production costs by 5% [3]. - Streamlined supply chain operations, resulting in a 10% reduction in delivery times [2]. - Enhanced inventory management systems, leading to a 7% decrease in stockouts [4]. Strategic Partnerships - Formed a strategic alliance with a leading tech company to co-develop innovative solutions [1]. - Signed a long-term agreement with a major supplier to secure raw materials at favorable rates [3]. - Collaborated with a global logistics firm to improve distribution efficiency [2]. Customer Engagement - Customer satisfaction scores improved by 8% due to enhanced service quality [4]. - Launched a new loyalty program that has already attracted 50,000 new members [1]. - Increased social media engagement by 25% through targeted marketing campaigns [2]. Regulatory Compliance - Successfully passed all regulatory audits with no major findings [3]. - Implemented new compliance training programs for all employees [4]. - Updated internal policies to align with the latest industry regulations [1]. Sustainability Initiatives - Reduced carbon emissions by 12% through the adoption of renewable energy sources [2]. - Launched a company-wide recycling program, achieving a 20% reduction in waste [3]. - Committed to achieving net-zero emissions by 2030 [4]. Employee Development - Introduced a new professional development program, resulting in a 15% increase in employee satisfaction [1]. - Increased training budgets by 10% to support skill development [2]. - Promoted 20% of employees to higher positions within the company [3]. Technology Innovation - Invested $10 million in AI research to enhance product capabilities [4]. - Developed a proprietary software platform that has improved operational efficiency by 15% [1]. - Partnered with a leading university to explore cutting-edge technologies [2].

ATLANTA, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible and innovative therapeutic and diagnostic products, announces financial results for the quarter ended September 30, 2024 and provides a corporate update. Corporate Highlights from 3Q 2024 to date Announced partnership with Boston IVF, prominent network of fertility centers, to offer FemaSeed®Annou ...