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 that its CEO, Kathy Lee-Sepsick, will present at the LSX World Congress USA in Boston from June 21-22, 2022. She will lead a session on overcoming regulatory hurdles for women’s health products, focusing on FemaSeed and FemBloc. The Women’s Health CEO Forum will also feature her insights on industry collaboration. This event gathers leaders in biotech and medtech to drive innovation and growth in women's reproductive health.
Femasys Inc. (NASDAQ: FEMY) announced Q1 2022 financial results, reporting a net loss of $2.88 million or $0.24 per share. General and administrative expenses rose by 62.3% to $1.45 million, and R&D expenses increased by 42.8% to $1.42 million. Sales of FemVue® decreased by 2.5% to $321,405. Despite these challenges, Femasys is set to commercialize FemCerv® and FemCath™ by year-end and is making progress in clinical trials for FemBloc and FemaSeed. The company aims to enhance women's health solutions with its expanding product portfolio.
Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on women's reproductive health, will participate in the 2022 Virtual Growth Conference from March 28-30. CEO Kathy Lee-Sepsick will join the panel titled “Advances in Women's Health: From Clinical to Commercial” on March 28 from 3:00 pm to 4:30 pm ET. The conference will discuss innovations in women's health, highlighting Femasys's ongoing development of minimally invasive technologies, including FemBloc® and FemaSeed® for permanent birth control and infertility treatment respectively. For more details, registration is available online.
Femasys Inc. (NASDAQ: FEMY) reported its 2021 financial results, showcasing a revenue increase of 13.7% to $1.18 million from FemVue® sales. R&D expenses slightly decreased by 1.1% to $4.08 million, while G&A expenses surged by 67.5% to $4.26 million due to increased professional costs. The net loss was $7.54 million, equating to $1.12 per share, a rise from the previous year's loss of $6.91 million. The company anticipates significant clinical advancements, including the upcoming launch of FemCerv® and completion of the FemBloc study enrollment.
Femasys Inc. (NASDAQ: FEMY) has appointed Dov Elefant as Chief Financial Officer, effective February 28, 2022. With 25 years of experience in financial management in the biotech sector, Elefant's expertise includes fundraising and mergers and acquisitions. He aims to enhance Femasys' growth and strategic direction in women's health technologies, including their lead products, FemBloc® and FemaSeed®. Additionally, an inducement option has been granted for 100,000 shares to Elefant, vesting over four years. This leadership change is expected to strengthen the company's financial strategy.
Femasys Inc. (NASDAQ: FEMY) has appointed Wendy Perrow to its board of directors, bringing extensive experience in fundraising and corporate strategy. Perrow's background includes leadership roles in several biotechnology companies, notably raising $31 million for Alba Therapeutics. This announcement coincides with the resignation of William Witte, who served since 2017. The leadership change comes at a crucial time as Femasys prepares for pivotal trials for its product candidates FemBloc and FemaSeed. Perrow aims to leverage her expertise to enhance the company's growth in women's reproductive health.
Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on women's reproductive health, announced its participation in two upcoming virtual conferences. The LifeSci Partners 11th Annual Corporate Access Event will feature CEO Kathy Lee-Sepsick on January 6, 2022, discussing gender equality in life sciences. Additionally, Femasys will present at the H.C. Wainwright BioConnect Conference, with a recording available from January 10, 2022. Femasys develops minimally invasive technologies, including FemBloc® and FemaSeed® for reproductive health needs.
Femasys Inc. (NASDAQ: FEMY) has received investigational device exemption approval for its pivotal LOCAL trial involving FemaSeed®, aimed at improving women's reproductive health. The company reported third-quarter 2021 financial results, highlighting a net loss of $(2.26) million, with revenue from FemVue® declining by 13.9% year-over-year to $269,581. However, sales increased by 22.2% for the nine months ended September 30, 2021, totaling $925,362. The company also announced its addition to the Russell Microcap® Index and the appointment of a new chief medical officer.
Femasys Inc. (NASDAQ: FEMY) announced that CEO Kathy Lee-Sepsick will present at The MedTech Conference on September 30, 2021, in Minneapolis. She will be part of a panel discussion titled “Early-Stage Medtech and Going Public,” scheduled from 10:00 to 10:35 a.m. ET. The conference runs from September 21 to 30, 2021, and focuses on advancements in medical technology. Femasys aims to address women’s health needs with innovative products, including FemBloc® and FemaSeed™. The company is committed to developing minimally invasive solutions for reproductive health.
Femasys Inc. (NASDAQ: FEMY) announced its inclusion in the Russell Microcap® Index, effective September 20, 2021. This recognition enhances the company's visibility in the global investment community and is expected to benefit stockholders. The CEO, Kathy Lee-Sepsick, highlighted the significance of this milestone following their IPO in June. The company aims to advance its product candidates, including FemBloc® and FemaSeed™, which target women’s healthcare needs through innovative, minimally invasive technologies. Membership in the index will last for one year.
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