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About Femasys Inc.
Femasys Inc. (NASDAQ: FEMY) is a pioneering biomedical company focused on transforming women's healthcare through the development of innovative, minimally invasive, and accessible therapeutic and diagnostic solutions. Headquartered in Atlanta, Georgia, the company addresses critical unmet needs in reproductive health, permanent birth control, and cancer diagnostics. With a comprehensive portfolio of FDA-cleared and globally approved products, Femasys is dedicated to improving clinical outcomes, patient accessibility, and overall healthcare economics.
Core Product Portfolio
Femasys offers a range of patented, office-based medical technologies designed to enhance patient care in key areas of women's health:
- FemaSeed® Intratubal Insemination: An FDA-cleared infertility treatment that delivers sperm directly to the fallopian tube, the natural site of conception. It serves as a cost-effective, less invasive alternative to in vitro fertilization (IVF).
- FemBloc® Permanent Birth Control: Currently in late-stage clinical development, this first-of-its-kind, non-surgical solution provides a safer, more accessible option for permanent contraception without the need for anesthesia or implants.
- FemVue® and FemVue® MINI: Diagnostic solutions for fallopian tube assessment using ultrasound, offering a reliable and non-invasive method for evaluating reproductive health.
- FemCath®: An intrauterine catheter designed for selective fallopian tube evaluation, complementing diagnostic procedures.
- FemCerv®: The first FDA-cleared endocervical tissue sampler for cervical cancer diagnosis, enabling comprehensive and uncontaminated sample collection during a pain-free office procedure.
- FemChec®: A contrast-generating product used in conjunction with FemBloc to confirm procedural success via ultrasound, eliminating the need for radiation-based methods.
Regulatory and Market Achievements
Femasys has achieved significant milestones, including FDA clearances and regulatory approvals in major markets such as the European Union, Canada, Japan, Israel, and the UK. The company's in-house manufacturing capabilities ensure compliance with stringent quality standards, including 21 CFR 820 and ISO 13485, reinforcing its commitment to delivering high-quality medical products. Additionally, its robust intellectual property portfolio, comprising over 180 patents globally, underscores its leadership in women's healthcare innovation.
Business Model and Market Position
Femasys operates within the highly regulated medical device and women's health industry, leveraging direct sales and strategic partnerships with healthcare providers and distributors to commercialize its products. The company’s focus on non-surgical, office-based solutions positions it as a disruptor in a market traditionally dominated by invasive and hospital-based procedures. By addressing gaps in affordability, accessibility, and patient convenience, Femasys caters to a growing demand for innovative healthcare solutions that align with modern clinical practices.
Competitive Landscape
Femasys competes with established players in the reproductive health and diagnostics sectors. However, its differentiation lies in the development of minimally invasive, cost-effective alternatives that can be administered in office settings. This approach not only reduces healthcare costs but also enhances patient satisfaction and provider efficiency.
Commitment to Women’s Health
Femasys is guided by a mission to empower women globally with better healthcare options. Its experienced management team, supported by world-class medical advisors, drives the company’s vision of innovation, integrity, and excellence. By focusing on underserved areas in women’s health, Femasys continues to make significant strides in improving patient outcomes and advancing medical science.
Femasys (NASDAQ: FEMY) has announced the publication of positive clinical trial results for FemBloc®, its permanent birth control solution, in the Journal of Gynecology & Reproductive Medicine. The prospective, multi-center trials demonstrated compelling effectiveness and five-year safety data for the in-office therapeutic product.
The trials showed high satisfaction rates among both patients and practitioners, supporting FemBloc's potential as a non-surgical alternative to traditional sterilization procedures. The peer-reviewed publication represents a significant milestone in Femasys's mission to provide safer, more accessible permanent contraception options.
Femasys Inc. (NASDAQ: FEMY) has received regulatory approvals from the UK's Medicines & Healthcare products Regulatory Agency (MHRA) for three products: FemaSeed®, an intratubal insemination product for female infertility treatment, FemVue® for tubal evaluation, and FemCerv® for cervical cancer detection.
These UK approvals follow previous clearances and approvals in the United States, Europe, Canada, and Israel, marking an important expansion of Femasys' global market presence. The company focuses on providing innovative, accessible in-office therapeutic and diagnostic solutions for women's health needs.
Femasys Inc. (FEMY) has received regulatory approvals from Israel's Medical Device Division (AMAR) for three products: FemaSeed®, an intratubal insemination product for female infertility treatment, along with two diagnostic devices - FemVue® for tubal evaluation and FemCerv® for cervical cancer detection.
This approval follows FemaSeed's previous regulatory milestones, including FDA clearance in September 2023 and EU CE mark approval in June 2024. The company aims to provide accessible, lower-cost options for women's healthcare through in-office therapeutic and diagnostic products. Femasys is focusing on commercial execution in the U.S. and select markets as it continues expanding its product availability globally.
Femasys (NASDAQ: FEMY) announces the European Patent Office's intention to grant two EU Patent Applications (24170531.8 and 18751753.7) for its FemBloc permanent birth control technology. The patents, expiring in 2039 and 2038 respectively, cover essential components of FemBloc's fallopian tube occlusion system, which provides a non-surgical alternative to traditional sterilization.
The company plans to pursue additional patent applications to strengthen its portfolio, which includes other products like FemaSeed, FemVue, FemCath, and FemCerv. This patent expansion in Europe precedes commercial availability and supports Femasys' mission to provide accessible women's health technologies globally.
Femasys (NASDAQ: FEMY) has received a Notice of Allowance from the USPTO for U.S. Patent Application 18/443,798, strengthening its intellectual property position for FemaSeed® Intratubal Insemination, a therapeutic product for female infertility treatment. The new patent, expected to expire no earlier than 2044, adds to Femasys' portfolio of over 180 patents globally.
The company plans to pursue additional patent applications to enhance protection for FemaSeed® and other products, including FemBloc® permanent birth control and diagnostic products FemVue®, FemCath®, and FemCerv®. FemaSeed is currently being marketed in the United States and Spain as a solution for women and couples seeking pregnancy assistance.
Femasys (NASDAQ: FEMY) announces a partnership with HRC Fertility, a major fertility services provider in the Western U.S., to offer FemaSeed Intratubal Insemination treatment at California locations. FemaSeed is a first-line fertility treatment that delivers sperm directly into the fallopian tube, showing higher efficacy compared to traditional intrauterine insemination for low male sperm count. The treatment offers a cost-effective option before pursuing IVF and ICSI procedures.
Femasys Inc. (NASDAQ: FEMY) announced the publication of positive data from its pivotal trial of FemaSeed® intratubal insemination (ITI) in the Journal of Gynecology & Reproductive Medicine. The trial demonstrated safety and effectiveness of FemaSeed ITI, with high satisfaction ratings from practitioners and patients. The study showed pregnancy rates more than double compared to intrauterine insemination (IUI) for low male sperm count cases, which affects approximately 50% of infertile couples. FemaSeed is positioned as a less invasive and more affordable alternative to in vitro fertilization (IVF) for infertility treatment.
Femasys (NASDAQ: FEMY) reported Q3 2024 financial results with sales increasing 127.1% to $554,908, driven by FemaSeed and FemVue products. The company announced partnerships with Boston IVF and strategic distribution deals in Spain expected to generate over $1.3 million next year. Net loss widened to $5.4 million ($0.24 per share) compared to $4.0 million ($0.26 per share) in Q3 2023. Cash position stood at $7.6 million, expected to fund operations into July 2025. The company received FDA 510(k) clearance for FemChec and CE Mark certification for FemVue MINI.
Femasys (NASDAQ: FEMY) announces its participation in the AAGL 2024 Annual Global Conference, scheduled for November 16-19 in New Orleans, Louisiana. The biomedical company will exhibit at booth #902, showcasing its late-stage clinical development product FemBloc® along with other commercially available solutions. The conference focuses on gynecological surgery and provides Femasys an opportunity to present its portfolio of in-office, accessible therapeutic and diagnostic products designed to address unmet needs in women's healthcare.
Femasys Inc. (NASDAQ: FEMY) announces the issuance of U.S. Patent No. 12,12796 by the USPTO for its FemBloc® permanent birth control device. The patent, expiring no earlier than 2039, strengthens the company's intellectual property position for its leading therapeutic product candidate. This adds to Femasys' portfolio of over 180 patents globally, protecting their suite of products including FemaSeed® for infertility treatment and diagnostic products FemVue®, FemCath®, FemCerv®, and FemChec®. The company is currently enrolling subjects in FemBloc's pivotal clinical trial.
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