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) generates frequent news flow as a biomedical company focused on women’s reproductive health, fertility treatment and non-surgical permanent birth control. News updates commonly highlight progress across its product portfolio, including FemaSeed Intratubal Insemination, FemVue and FemVue Controlled diagnostic devices, FemBloc permanent birth control, and the FemChec diagnostic product.
Investors following FEMY news can expect coverage of regulatory milestones, such as U.S. FDA 510(k) clearance for FemVue Controlled and Investigational Device Exemption approval to advance the final phase of the FINALE pivotal trial for FemBloc. Company announcements also report international approvals for FemBloc in Europe, the UK and New Zealand, as well as the launch of post-market surveillance studies under EU Medical Device Regulation.
Femasys news releases frequently describe commercialization developments, including partnerships with distributors like Kebomed to expand FemBloc access in France and the Benelux region, initial commercial orders in European markets, and collaborations with healthcare providers such as Refuah Health Center to offer FemaSeed as a first-line infertility treatment in community-based care. Financial and capital markets updates, including quarterly results, underwritten offerings, and private placements of senior secured convertible notes and warrants, are also disclosed through press releases and related SEC filings.
This FEMY news page aggregates these updates in one place, making it easier to track clinical progress, regulatory events, commercialization agreements, and listing-related notices from Nasdaq. Readers can use this feed to review how Femasys is executing on its women’s health strategy and how new information may relate to the company’s fertility and permanent birth control portfolio over time.
Femasys Inc. (NASDAQ: FEMY) reported key developments in its latest press release, highlighting accelerated enrollment in the FemaSeed® trial focusing on male factor infertility and commercial availability of FemCerv®. The company plans to file an Investigational Device Exemption (IDE) for FemBloc® in Q1 2023. Financial results showed revenue growth from FemVue® but an increase in net loss, which reached $2.98 million for Q3 2022. R&D and G&A expenses rose significantly, impacting profitability. Cash reserves decreased from $24.78 million at year-end 2021 to $16.01 million by September 30, 2022.
Femasys Inc. (NASDAQ: FEMY) has updated the design of its FemaSeed® trial to focus on male factor infertility, aiming for faster patient enrollment. The trial, which is a multi-center study, will evaluate 214 women undergoing FemaSeed cycles, with primary endpoints centered on pregnancy rates and safety over seven weeks. The redesign reflects a strategy to effectively address a significant issue, as male factor infertility accounts for about 40-50% of all infertility cases globally. Enrollment is expected to be completed in 2023.
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.