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) announced a definitive agreement for a registered direct offering of 3,196,722 shares at $1.22 each, alongside a concurrent private placement of unregistered warrants for the same number of shares, exercisable at $1.095. The gross proceeds are expected to be approximately $3.9 million, aimed at working capital and general corporate purposes. The offering is set to close around April 20, 2023, pending customary conditions. H.C. Wainwright & Co. is serving as the exclusive placement agent. Both the registered and unregistered offerings have specific regulatory frameworks and cannot be publicly reoffered without appropriate registration.
Femasys Inc. (NASDAQ: FEMY) has received product approval from Health Canada for its innovative infertility solution, FemaSeed®. This first-of-its-kind artificial insemination approach aims to deliver sperm directly to the fallopian tubes, making it a less invasive and more affordable alternative to traditional methods like IVF. FemaSeed complements Femasys' existing product, FemVue®, which assesses fallopian tube patency. The company is also progressing towards a U.S. commercial launch in 2024, pending FDA clearance. CEO Kathy Lee-Sepsick emphasized that these advancements will provide safe and cutting-edge options for couples facing infertility.
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.
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