FEMASYS INC Stock Price, News & Analysis

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.

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.