Core Insights - Femasys, Inc. has announced a partnership with CNY Fertility to provide its FemaSeed intratubal insemination product as a treatment option for infertility across CNY Fertility's 11 locations [1][2] Company Overview - Femasys is a biomedical innovator focused on women's health, offering a range of therapeutic and diagnostic products that are disruptive and accessible [4] - The company has received regulatory approvals for its product portfolio worldwide, including FDA clearance for FemaSeed in the U.S. and approvals in Europe, UK, Canada, and Israel [4] Product Details - FemaSeed is designed to enhance fertilization by delivering sperm directly into the fallopian tube, providing a safe and cost-effective first-line option for couples facing infertility [3] - The product serves as an alternative to intrauterine insemination (IUI) and is positioned as a less burdensome step before in vitro fertilization (IVF) [3] Partnership Significance - The partnership with CNY Fertility aims to expand access to FemaSeed, aligning with CNY's mission to provide comprehensive and affordable fertility solutions [2][6] - CNY Fertility has a strong track record, having helped create over 30,000 lives since its inception in 1997, emphasizing its commitment to accessible fertility treatments [6]

Core Insights - Femasys Inc. has secured distribution partnerships in Spain for its FemBloc product, marking a significant step in its global expansion strategy [1][2] - FemBloc is a non-surgical permanent birth control solution that utilizes a patented delivery system to block fallopian tubes, offering a safer alternative to traditional surgical methods [3][5] Company Overview - Femasys is a biomedical innovator focused on women's health, with a portfolio of patent-protected therapeutic and diagnostic products [4] - The company has received regulatory approvals for its products in various international markets, including the U.S., Europe, UK, Canada, and Israel [4] Product Details - FemBloc is the first non-surgical approach for permanent birth control, involving the placement of a synthetic tissue adhesive into the fallopian tubes [3][5] - The product aims to reduce risks associated with surgical sterilization, such as infection and bleeding, and is designed to be a more accessible and cost-effective option [3][5] Market Positioning - The distribution partners, Comercial Medico Quirurigca, SA and Durgalab, have extensive experience in women's healthcare, having previously marketed the Conceptus Essure product [2] - The approval of FemBloc in Europe and the ongoing clinical trials for U.S. FDA approval indicate a strong market entry strategy [5]

Core Insights - Femasys Inc. has received the first regulatory approval in the world for the FemBloc delivery system, a non-surgical option for permanent birth control, with CE mark certification expected mid-2025 [1][2][6] - The FemBloc system represents a significant advancement in women's reproductive health, providing a safer and more accessible alternative to traditional surgical sterilization methods [2][4] Company Overview - Femasys is a biomedical innovator focused on addressing unmet needs in women's health, with a portfolio of therapeutic and diagnostic products [5] - The company has received regulatory approvals for its products globally, including FemaSeed for infertility treatment and FemVue for fallopian tube assessment [5][6] Product Details - The FemBloc delivery system allows for the minimally-invasive placement of a synthetic tissue adhesive into the fallopian tubes, leading to permanent blockage over time [4][6] - This non-surgical approach is designed to reduce risks associated with traditional surgical methods, such as infection and anesthesia-related complications [3][4] Market Context - The approval of FemBloc addresses a long-standing gap in permanent contraception options, as surgical sterilization has been the predominant method for over a century [3] - The rise in unintended pregnancies highlights the need for innovative contraceptive solutions, making FemBloc a timely development in the market [3]

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]

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 ...