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 (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.
Femasys (NASDAQ: FEMY) announces a partnership with Boston IVF to offer FemaSeed intratubal insemination across nearly 30 fertility centers nationwide. FemaSeed, designed as a first-line treatment for artificial insemination, delivers sperm directly to the fallopian tube where conception occurs. The treatment has shown significantly higher efficacy compared to traditional intrauterine insemination for low male sperm count and serves as a cost-effective option before IVF procedures. Boston IVF, one of the largest U.S. fertility service providers, will integrate FemaSeed into their suite of treatment options.
Femasys Inc. (Nasdaq: FEMY) announces its participation in the American Society of Reproductive Medicine's (ASRM) 2024 Scientific Congress and Expo from October 19-23 in Denver, Colorado. The company will showcase its products at booth #243, with FemaSeed® and FemVue® featured in ASRM's KEEPR program for residents on October 23.
Notably, Femasys' VP of Education and Global Training, Andrew Young, has been elected chairman of the ASRM Corporate Member Council for a one-year term. This council facilitates dialogue between ASRM officers, directors, and corporate members to drive education and innovation in reproductive medicine.
CEO Kathy Lee-Sepsick emphasized the importance of ASRM's event for demonstrating Femasys' product value to healthcare practitioners and thought leaders, as well as engaging with young physicians through product training.
Femasys Inc. (FEMY), a biomedical company focusing on women's healthcare, announces its participation in the 2024 Maxim Healthcare Virtual Summit. Founder, President, and CEO Kathy Lee-Sepsick will engage in a fireside chat with Jason McCarthy, Ph.D., Senior Managing Director and Head of Biotechnology Research at Maxim Group.
The virtual summit is scheduled for October 15-17, 2024, with Femasys' fireside chat taking place on Thursday, October 17, at 11:00 AM ET. Interested parties can access the webcast through the provided link. Additionally, Kathy Lee-Sepsick and CFO Dov Elefant will be available for one-on-one meetings throughout the summit.
Femasys is known for its broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products addressing significant unmet needs of women worldwide.
Femasys Inc. (Nasdaq: FEMY) has received a second order from its Spanish distribution partners following successful commercial FemaSeed® infertility treatments in Europe. The Femasys team traveled to Madrid to train healthcare practitioners on the innovative procedure, which enhances natural fertilization by delivering sperm directly to the fallopian tube.
CEO Kathy-Lee Sepsick emphasized the importance of providing a lower-cost infertility treatment option, especially in the public sector where women often face long waits for IVF. Femasys recently announced strategic partnerships with Comercial Medico Quirurigca, SA (CMQ) for northern Spain and Durgalab for southern Spain to distribute FemaSeed and FemVue products.
Femasys Inc. (Nasdaq: FEMY) has announced the onboarding of its first infertility medical clinic customers to offer FemaSeed treatment in California and Florida. FemaSeed is a unique form of artificial insemination that delivers sperm directly into the fallopian tube, aiming to enhance natural fertilization. It's positioned as a cost-effective and safe first-line treatment option compared to IVF and ICSI.
Reproductive Fertility Center in Los Angeles and Palm Beach Fertility Center in Boca Raton are the first clinics to offer FemaSeed. Both clinics expressed enthusiasm about providing this new option to patients, citing its potential benefits over traditional IUI and its affordability. Femasys anticipates broader acceptance of FemaSeed as its benefits become more widely recognized in the medical community.
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