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) 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.
Femasys Inc. (NASDAQ: FEMY) has appointed Dr. Edward G. Evantash as its new Chief Medical Officer, bringing over 20 years of experience in medical affairs, particularly in women's healthcare. Dr. Evantash, previously with Alydia Health and Hologic, will lead Femasys' clinical development programs, including advancing the late-stage candidates, FemaSeed™ and FemBloc®. His expertise aims to address unmet needs in reproductive health and enhance Femasys' strategic initiatives, particularly in clinical trial execution and FDA submissions.
Femasys Inc. (NASDAQ: FEMY) announced its IPO, raising $31.6 million, and appointed Anne Morrissey to its Board of Directors. The company initiated a pivotal LOCAL trial for its FemaSeed™ product with 792 patients enrolled. In Q2 2021, Femasys reported a 77.9% increase in FemVue sales, totaling $326,006. However, net loss for the quarter decreased to $1,083,059, or $0.52 per diluted share. The company aims to leverage its IPO proceeds to sustain operations through at least 2022, despite ongoing increases in general and administrative expenses.
Femasys Inc. (NASDAQ: FEMY) has initiated a pivotal trial for its innovative infertility treatment, FemaSeed, which features localized directional insemination. The trial, named LOCAL, aims to enroll up to 792 patients across 20 U.S. centers to evaluate safety and effectiveness. The trial's primary endpoints are clinical pregnancy rates and safety measures over a duration of seven weeks. This initiative underscores Femasys' commitment to providing cost-effective, less invasive infertility solutions amid a growing public health concern.
On June 21, 2021, Chardan announced its role as the lead left bookrunner for the $34.45 million IPO of Femasys, Inc. (NASDAQ: FEMY), a biomedical company dedicated to women's healthcare. The funds raised will support Femasys’ clinical trials for its FemBloc and FemaSeed systems, along with product development and hiring efforts. Chardan has prioritized investing in healthcare companies addressing significant unmet needs, reflecting a commitment to ESG principles.
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