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Femasys Inc (FEMY) delivers innovative solutions in women's healthcare through minimally invasive diagnostic tools and therapeutic devices. This news hub provides investors and industry observers with timely updates on corporate developments, regulatory milestones, and clinical advancements.
Access comprehensive coverage of FEMY's progress in fertility treatments, non-surgical birth control technologies, and companion diagnostics. Our curated news collection features official press releases, partnership announcements, and product clearance updates from global health authorities.
Key focus areas include FDA regulatory developments, international market expansions, and research breakthroughs. All content is sourced directly from company communications and verified financial channels to ensure accuracy and compliance with disclosure standards.
Bookmark this page for streamlined tracking of Femasys' biomedical innovations and corporate announcements. For complete investment analysis, combine these updates with SEC filings and market performance data available through Stock Titan's research tools.
Femasys Inc. (NASDAQ: FEMY) announced financial results for Q2 2024 and provided a corporate update. Key highlights include:
1. Received EU MDR certification and CE Mark for four women's health products.
2. Completed build-out of U.S. commercial team.
3. FemaSeed® demonstrated pregnancy rates more than double historic IUI rates for male factor infertility.
Financial results:
- Q2 2024 sales: $221,484 (down from $320,514 in Q2 2023)
- Q2 2024 net loss: $4,684,574 or ($0.21) per share
- Cash and equivalents as of June 30, 2024: $13.5 million
- Sufficient funds to operate into July 2025
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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