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Femasys Inc. (NASDAQ: FEMY) is a leading biomedical company dedicated to transforming women's healthcare through innovative solutions. The company focuses on developing and providing minimally invasive, non-surgical products that are accessible in-office, thus improving patient care and overall health economics. Femasys' mission addresses severely underserved areas in women's health, aiming to make a significant clinical impact worldwide.
The company's recent achievements include the FDA clearance and commercial launch of FemaSeed® Intratubal Insemination, a novel infertility treatment that enhances fertilization by delivering sperm directly to the fallopian tube. This product offers a cost-effective and less invasive alternative to traditional infertility treatments like IVF and ICSI. FemaSeed has demonstrated promising results, with a 24% pregnancy rate in severe male factor infertility cases.
Femasys is also advancing the development of FemBloc®, a non-surgical, in-office permanent birth control method currently in late-stage clinical trials. This product aims to provide a safer and more affordable option compared to long-standing surgical alternatives.
The company's diagnostic product portfolio includes FemVue® for fallopian tube assessment, FemCath® for selective fallopian tube evaluation, and FemCerv® for cervical cancer diagnosis. These products have achieved regulatory approvals in the U.S., Canada, and other international markets, and are ready for commercial deployment.
Femasys prides itself on its experienced management team, boasting over 200 years of collective industry expertise, and the guidance of world-class medical advisors. All products developed by Femasys adhere to stringent FDA regulations and ISO 13485 standards, ensuring the highest quality and compliance.
Recent news highlights include the first commercial procedure using FemaSeed, the release of promising topline data from pivotal trials, and significant capital infusion to support commercial initiatives into the second half of 2025. The company's strategic focus remains on the commercialization of its infertility and diagnostic product portfolios, ongoing pivotal trials, and addressing the critical unmet needs in women's healthcare.
Femasys (Nasdaq: FEMY) has announced its participation in the 40th Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE) in Amsterdam from July 7-10, 2024. The conference is a key event for the reproductive health community. Femasys will be exhibiting at booth #11,111. This announcement follows the company’s recent CE Mark approval for four of its products - FemaSeed®, FemVue®, FemCerv®, and FemCath®. This certification allows these products to be commercially sold within the European Union under the new medical device regulations.
Founder, President, and CEO Kathy Lee-Sepsick highlighted the significance of this event in fostering potential partnerships for European and international distribution. ESHRE's mission is to enhance awareness and knowledge surrounding infertility and reproductive care. The conference will offer speeches, presentations, and networking opportunities aimed at advancing reproductive biology and medicine. For more details, visit eshre.eu/ESHRE2024.
Femasys has received CE Mark approval for four of its women's health products: FemaSeed®, FemVue®, FemCerv®, and FemCath®. This approval follows the European Union Medical Device Regulation (MDR) certification, enabling the company to begin commercializing its products in Europe. The MDR certification, obtained with TÜV SÜD's assistance, ensures compliance with stringent European standards for clinical safety and fair market access. This significant milestone allows Femasys to expand its market reach and underscores its commitment to quality and safety.
Femasys announced that CEO Kathy Lee-Sepsick met with the White House’s Office of Science and Technology Policy to discuss the Cancer Moonshot initiative and the company's diagnostic tool, FemCerv. FemCerv is designed for the detection of cervical cancer, allowing for the collection of an uncontaminated sample virtually pain-free. Femasys aims to expand its cancer diagnostic tools to include an endometrial sampler for uterine cancer. Additionally, the company will showcase its products at the 2024 ACOG Annual Clinical and Scientific Meeting in San Francisco from May 17-19.
Femasys CEO Kathy Lee-Sepsick met with the White House’s Gender Policy Council to discuss the company's reproductive health products and the future of women's health in the U.S. The meeting supported the President's Executive Order on Advancing Women’s Health Research and Innovation, highlighting funding needs for women’s healthcare initiatives. Femasys, an Atlanta-based biomedical company, offers innovative in-office therapeutic and diagnostic products. The company will display its products, including FemBloc® and FemaSeed®, at the ACOG Annual Meeting in San Francisco from May 17-19, 2024.
Femasys Inc. (NASDAQ: FEMY) announces financial results for Q1 2024, highlighting positive topline data for FemaSeed infertility treatment, commercial procedures, appointment of Richard Spector as Chief Commercial Officer, and initiation of pivotal trial for FemBloc. The company is well-positioned to commercialize its infertility portfolio, with cash to fund operations into H2 2025. Financially, R&D expenses increased, sales decreased, and net loss grew, but the company believes its cash and equivalents will suffice. Current assets, liabilities, and stockholders' equity are detailed in the PR.
Femasys Inc. (Nasdaq: FEMY) announces the expansion of its commercial management team, adding experienced professionals to drive strategic initiatives and launch efforts at the 2024 ACOG Meeting. The team will focus on the infertility portfolio, led by FemaSeed®, a cost-effective and safe approach for artificial insemination. The company aims to address the record-low birth rates in the U.S. by providing innovative solutions to women's healthcare needs.
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