Welcome to our dedicated page for Femasys news (Ticker: FEMY), a resource for investors and traders seeking the latest updates and insights on Femasys stock.
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 Inc. (Nasdaq: FEMY) has secured strategic distribution partnerships for its CE-marked products, including FemaSeed® and FemVue®, in Spain. The company has partnered with Comercial Medico Quirurigca, SA (CMQ) for northern Spain and Durgalab for southern Spain, marking its first EU distribution agreements. These partnerships represent a significant step in Femasys' global expansion, with a commitment to purchase a minimum of $1.3 million of FemaSeed over the next year.
Femasys CEO Kathy-Lee Sepsick emphasized the importance of these partnerships in expanding access to affordable and effective women's healthcare solutions. The distributors' expertise in women's healthcare and understanding of Femasys' infertility portfolio are expected to drive market penetration in Spain.
Femasys Inc. (Nasdaq: FEMY) has received 510(k) clearance from the FDA for FemChec®, an innovative diagnostic solution for checking fallopian tubes. FemChec is designed for controlled delivery of contrast to confirm tubal status. It is a important component of Femasys' FemBloc® non-surgical permanent birth control solution, currently in late-stage pivotal trials. FemChec allows for procedure success confirmation by the same practitioner using natural contrast and ultrasound, eliminating the need for radiology referrals and radiation exposure. This clearance strengthens Femasys' position in providing safe and advanced diagnostic and therapeutic solutions for women's healthcare needs.
Femasys Inc. (Nasdaq: FEMY) will exhibit at the Canadian Fertility and Andrology Society's 70th Annual Meeting from September 12-14, 2024, in Vancouver. The company, focused on women's health, will showcase its portfolio of infertility products, including the recently Canadian-approved FemVue MINI, an eco-friendly fallopian tube assessment solution, and FemaSeed, a next-generation artificial insemination product.
CEO Kathy-Lee Sepsick highlighted the importance of connecting with practitioners whose patients could benefit from Femasys' suite of products. The FemVue MINI maintains the efficacy of its predecessor while embracing an eco-conscious design, aiming to improve resource management in women's healthcare. This Canadian approval is expected to expand access to advanced diagnostic technology for women across the country.
Femasys Inc. (FEMY), a biomedical company focusing on women's health, announces its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event will take place from September 9-11, 2024 at the Lotte New York Palace Hotel. Kathy Lee-Sepsick, Founder, President, and CEO of Femasys, will engage in a fireside chat hosted by Emily Bodnar, Life Sciences Analyst.
The presentation will be available on-demand starting September 9, 2024, at 7:00 AM ET. Investors can access the webcast through the provided link or the investor relations section of the Femasys website. The replay will be available for approximately 90 days after the event. Additionally, Kathy Lee-Sepsick and CFO Dov Elefant will be available for one-on-one meetings throughout the conference.
Femasys Inc. (NASDAQ: FEMY) has received CE mark certification and Health Canada approval for its FemVue® MINI, a compact and eco-friendly fallopian tube assessment solution. This new product maintains the high efficacy of its predecessor while embracing a smaller, more environmentally conscious design. The FemVue MINI aligns with Femasys' commitment to developing safe, affordable, and accessible technologies in women's health care.
The approvals open new opportunities for expanded access to advanced diagnostic technology for women across Europe and Canada. This development is part of Femasys' broader initiative to integrate environmentally impactful programs across its product lines, demonstrating the company's dedication to balancing technological advancement with responsible resource management.
Femasys Inc. (Nasdaq: FEMY), a biomedical company focused on women's reproductive health, hosted Congresswoman Lucy McBath at its Georgia headquarters. The visit aimed to showcase Femasys' advancements in women's healthcare. CEO Kathy Lee-Sepsick emphasized the need for better funding and attention to women's reproductive health, expressing hope for continued dialogue with stakeholders.
Femasys offers minimally-invasive solutions with four commercially available products: FemaSeed® (intratubal insemination), FemVue® (contrast-generating device), FemCath® (selective delivery catheter), and FemCerv® (endocervical tissue sampler). These products are approved in the U.S., Canada, and Europe. The company's lead product candidate, FemBloc® (permanent birth control), is in late-stage clinical development.
Femasys Inc. (NASDAQ:FEMY), a biomedical company focused on women's health, will participate in the Q3 Investor Summit on August 20th, 2024. The virtual event, themed around micro-cap companies with catalysts or strong market performance, will feature Femasys presenting at 1:30 pm ET. The company, known for its portfolio of in-office, accessible therapeutic and diagnostic products, will be available for one-on-one meetings throughout the day. This microcap event offers investors an opportunity to engage with 50 selected companies and includes live Q&A sessions. Interested qualified investors can register for complimentary access to the summit.
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.
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