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), a biomedical company dedicated to women's reproductive health, will attend the 78th Annual ASRM Scientific Congress in Anaheim, California, from October 22-26, 2022. The management team will showcase innovative technologies such as FemaSeed® and FemVue® at booth #1011. Femasys aims to address women's needs globally with minimally invasive in-office products, including FemBloc® for permanent birth control and FemCath™ for assessing fallopian tubes. To learn more, visit www.femasys.com.
Femasys Inc. (NASDAQ: FEMY) has appointed Christine Thomas as senior vice president of regulatory and clinical affairs, effective October 10, 2022. With over 20 years of experience in medical device regulation, she will lead regulatory and clinical efforts for Femasys's FemBloc and FemaSeed programs. Thomas joins from IQVIA MedTech, following roles at various medical device firms. In connection, Femasys has granted her an option to purchase 50,000 shares of common stock, vesting over four years. This strategic hire aims to enhance the company's innovation in women's health.
Femasys Inc. (NASDAQ: FEMY) announced the completion of enrollment for its Stage 2 study of FemBloc®, a nonsurgical solution for permanent birth control. The company aims to file an investigational device exemption for a pivotal trial supporting pre-market authorization in Q1 2023. The study validates confirmation tests comparing ultrasound and traditional radiology approaches, with safety monitoring extending for about 68 months post-procedure. Femasys is committed to advancing innovative reproductive health solutions for women, with other products in its pipeline.
Femasys Inc. (NASDAQ: FEMY) has announced the commercial availability of FemCerv®, an innovative endocervical tissue sampler designed to improve tissue quality and quantity, enhancing women's healthcare. This new device aims to replace outdated products, providing a more comfortable and effective solution for tissue sampling during abnormal pap smear evaluations. Additionally, the company has bolstered its management team with the appointment of Michael Meier as Vice President of Sales and Marketing, who brings over 20 years of experience in medical device commercialization.
Femasys Inc. (NASDAQ: FEMY) announced that CEO Kathy Lee-Sepsick will present virtually at the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. The presentation will be available on-demand starting at 7:00 AM ET on September 12.
The conference will feature a fireside chat format, and Femasys management will hold one-on-one meetings during the event. Femasys focuses on developing minimally invasive technologies for reproductive health, including FemBloc® for birth control and FemaSeed® for infertility.
Femasys Inc. (NASDAQ: FEMY) reported its financial results for Q2 and the first half of 2022, highlighting important advancements in women's reproductive health technologies. Revenue for the six months decreased by 4.8% to $624,518, with R&D expenses rising significantly by 53.1% to $2.9 million due to increased clinical costs. The net loss grew to $5.5 million, or $0.47 per share. Upcoming product launches, including FemCerv® and FemCath™, are expected by year-end. Enrollment for the FemBloc® study is on track, with an interim analysis for FemaSeed® due in Q4.
Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on women's health, will hold one-on-one virtual meetings during the BTIG Biotechnology Conference on August 8-9, 2022, at the St. Regis New York Hotel. The company develops minimally invasive technologies for reproductive health, including its lead products, FemBloc® for permanent birth control and FemaSeed® for infertility. Interested participants are encouraged to contact their BTIG representative for scheduling.
Femasys Inc. (NASDAQ: FEMY) will host a significant webinar on July 28, 2022, at 10:30 AM EDT, featuring Dr. Paul D. Blumenthal, who will discuss the company's innovative FemBloc solution for permanent birth control. This event comes in response to the reversal of Roe v. Wade, emphasizing the unmet needs for permanent contraceptive options. FemBloc utilizes a unique delivery method that safely closes the fallopian tubes without surgery, aiming for confirmation of success within 90 days. A live Q&A session will follow the presentation.
Femasys Inc. (NASDAQ: FEMY) has been invited to present at the Women’s Health Panel Discussion hosted by Maxim Group LLC on July 13, 2022, at 11:00 a.m. ET. Kathy Lee-Sepsick, CEO, will discuss the implications of the Supreme Court's decision to overturn Roe v. Wade on women's health and contraception. This virtual event will spotlight the critical issues in women's reproductive health, bringing together key industry players. Femasys is known for its innovations in minimally invasive reproductive health technologies, including FemBloc and FemaSeed.
Femasys Inc. (NASDAQ: FEMY) announced the appointment of Charles Larsen as the new non-executive Chair of the Board, succeeding founder Kathy Lee-Sepsick. With over 40 years in the medical device industry, Larsen is expected to enhance corporate governance and aid Femasys in advancing its product candidates like FemBloc and FemaSeed. Kathy Lee-Sepsick emphasized Larsen's leadership experience and insight in strategic transformations as vital for the company's mission to improve women's health globally.
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