ATLANTA, Jan. 30, 2025 (GLOBE NEWSWIRE) -- Femasys Inc., (NASDAQ:FEMY), a leading biomedical innovator addressing significant unmet needs in women's health worldwide, with a broad portfolio of disruptive, accessible in-office therapeutic and diagnostic products, announces the European Patent Office ("EPO") issued notices of Intention to Grant for two EU Patent Applications, EPO Application Nos. 24170531.8 and 18751753.7, which will have anticipated expirations in 2039 and 2038, respectively. Femasys plans t ...

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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________to____________ Commission file number: 001-40492 | --- | --- | --- | |------------------------------------------------------------------------ ...

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 ...

ATLANTA, Nov. 01, 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 that the United States Patent and Trademark Office (“USPTO”) issued U.S. Patent No. 12,12796 covering FemBloc® permanent birth control. This further strengthens Femasys’ intellectual property position and coverage for FemBloc, the Comp ...

ATLANTA, Oct. 10, 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 inoffice, accessible, and innovative therapeutic and diagnostic products, announces that the Company will be exhibiting at the American Society of Reproductive Medicine's (ASRM) 2024 Scientific Congress and Expo, being held October 19-23 in Denver, Colorado. The Company will be showcasing its solutions at booth #243. ...

ATLANTA, Oct. 02, 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 inoffice, accessible, and innovative therapeutic and diagnostic products, announces that the Company has received its second order from its strategic distribution partners after successfully completing its first commercial FemaSeed® procedures in Europe. Members of the Femasys team traveled to Madrid to in-service he ...