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. develops biomedical products for women’s reproductive health, with news centered on fertility treatment, fallopian tube assessment, and non-surgical permanent birth control. Its portfolio includes FemaSeed intratubal insemination, FemaSeed Complete for in-office fertility care, FemVue for ultrasound-based fallopian tube evaluation, FemBloc permanent birth control, and related diagnostic products such as FemChec.
Recurring updates cover product commercialization in OB/GYN settings, international distribution and market access, regulatory approvals outside the United States, U.S. clinical and regulatory development for FemBloc, reimbursement-related developments, financing, operating results, and governance changes.
Femasys Inc. (NASDAQ: FEMY) reported its 2022 financial results, revealing a net loss of $11.39 million, equating to $0.96 per share. Despite a 2.2% increase in sales to $1.21 million, research and development expenses rose significantly to $5.81 million, driven by clinical trial support and personnel costs. The gross margin decreased to 63.4% from 68.6% in 2021. Femasys continues to advance its clinical programs for FemBloc® and FemaSeed®, with notable enrollment progress in pivotal trials. The company has sufficient cash, expected to fund operations into Q1 2024, while recently launching commercial products FemCath™ and FemCerv®.
Femasys Inc. (NASDAQ: FEMY) announced its CEO, Kathy Lee-Sepsick, will speak at the South By Southwest (SXSW) 2023 Conference in Austin, Texas, from March 10-19, 2023. She is set to participate in a panel titled “The Post-Roe Fertility Journey” on March 11, 2023, discussing women's health considerations post-Roe regarding fertility management. Femasys focuses on developing minimally invasive technologies for reproductive health, including FemBloc® for permanent birth control and FemaSeed® for infertility. Their marketed products include FemVue® for fallopian tube assessment and FemCerv® for tissue sampling.
Femasys Inc. (NASDAQ: FEMY) has announced the commercial availability of FemCath™, the first FDA-cleared intrauterine catheter designed for selective evaluation of fallopian tubes alongside the FemVue device. This innovative technology enhances infertility diagnostics, vital before starting treatment options like FemaSeed®, a unique intrauterine insemination solution, and FemBloc®, a nonsurgical birth control method. CEO Kathy Lee-Sepsick emphasizes this launch as a significant step forward in providing essential reproductive health solutions for women, with FemCath expected to contribute additional revenue.
Femasys Inc. (NASDAQ: FEMY) successfully launched its FemCerv® endocervical tissue sampler at the AAGL conference, receiving positive feedback from over 2,000 gynecologic specialists. This innovative product aims to enhance tissue quality and reduce discomfort during cervical cancer detection. Additionally, FemVue®, the first FDA-cleared device for fallopian tube evaluation, also garnered attention. Femasys plans to expand its product portfolio further with the upcoming launch of FemCath™ and continuously advance clinical programs including FemaSeed® and FemBloc®.
Femasys Inc. (NASDAQ: FEMY) has achieved over 25% enrollment in its FemaSeed de novo clinical trial, focusing on male factor infertility. The trial aims to evaluate the safety and effectiveness of FemaSeed, a cost-effective alternative to assisted reproduction methods like IVF. CEO Kathy Lee-Sepsick highlighted the potential impact on the estimated 50% of infertility cases linked to male factors. The trial enrollment is expected to complete in 2023, with results supporting FDA review for FemaSeed.
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.