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Femasys Inc. - FEMY STOCK NEWS

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.

Rhea-AI Summary
Femasys demonstrates compliance with regulatory requirements for multiple countries, including the USA. No nonconformances or findings in annual audit. Femasys has Certificates of Registration for MDSAP and ISO 13485. Femasys is committed to bringing innovative solutions to women worldwide.
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Femasys activates enrollment for its pivotal FemBloc trial at its first academic site in Brooklyn, NY
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Femasys receives FDA clearance for FemaSeed®, an innovative infertility treatment
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Femasys achieves First-Patient-In for pivotal trial of FemBloc, a non-surgical birth control solution
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Femasys to present at H.C. Wainwright Conference
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Femasys obtains MDEL license from Health Canada, allowing direct sales of its approved medical products in Canada.
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Femasys Inc. (NASDAQ: FEMY) announced the commencement of patient enrollment in a pivotal trial for lead product candidate, FemBloc®, and achieved three product approvals in Canada. The company raised $3.9 million in a registered direct offering. The financial results for the second quarter ended June 30, 2023, were also provided, showcasing the progress in clinical development and commercial approvals.
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Femasys Inc. (NASDAQ: FEMY) announces enrollment in landmark trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control, a non-surgical, permanent birth control option. The FINALE trial aims to investigate the safety and efficacy of FemBloc, addressing the high unmet need for women seeking permanent birth control. Femasys is striving to provide a safe and accessible permanent birth control alternative for women, replacing decades-old technology with innovative product candidates.
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Femasys receives Notice of Allowance for patent application, strengthening intellectual property position for FemBloc permanent birth control. Anticipated patent expiration in 2039. Company committed to protecting innovation and commercial opportunity.
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Femasys Inc. has received approval from the FDA for an Investigational Device Exemption (IDE) to conduct a pivotal clinical trial for FemBloc, a non-surgical, non-implant, in-office solution for permanent birth control. The trial is set to begin in Q3 2023. FemBloc aims to eliminate the need for anesthesia, incisions, and permanent implants, offering women a safer and more convenient option for permanent birth control. FemBloc is one of Femasys' lead product candidates and, if approved, will complement the company's existing diagnostic products.
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FAQ

What is the current stock price of Femasys (FEMY)?

The current stock price of Femasys (FEMY) is $1.175 as of November 4, 2024.

What is the market cap of Femasys (FEMY)?

The market cap of Femasys (FEMY) is approximately 26.3M.

What is Femasys Inc. known for?

Femasys Inc. is known for developing innovative, in-office, minimally invasive solutions to address significant unmet needs in women's healthcare, including infertility treatments and diagnostic products.

What is FemaSeed?

FemaSeed is an FDA-cleared intratubal insemination product designed to enhance natural fertilization by delivering sperm directly to the fallopian tube, offering a less invasive and more affordable alternative to traditional infertility treatments like IVF.

What are the recent achievements of Femasys?

Recent achievements include the first commercial procedure using FemaSeed, FDA clearance for multiple products, promising trial data, and securing capital to support operations into the second half of 2025.

What is FemBloc?

FemBloc is a non-surgical, in-office permanent birth control method currently in late-stage clinical development, intended to provide a safer and more affordable alternative to traditional surgical options.

What diagnostic products does Femasys offer?

Femasys offers FemVue for fallopian tube assessment by ultrasound, FemCath for selective fallopian tube evaluation, and FemCerv for cervical cancer diagnosis.

How does Femasys ensure product quality?

Femasys ensures product quality by adhering to FDA regulations and ISO 13485 standards for all its manufacturing activities and products.

What markets has Femasys achieved regulatory approvals in?

Femasys has achieved regulatory approvals in the United States, Canada, and several other international markets.

Who leads Femasys Inc.?

Femasys is led by a management team with over 200 years of collective industry experience and the guidance of world-class medical advisors.

What are the financial prospects for Femasys?

Femasys has secured sufficient capital to fund operations into the second half of 2025, supporting its strategic focus on commercialization and advancing clinical trials.

Where can I learn more about Femasys' products and updates?

For more information about Femasys' products and latest updates, visit their website at www.femasys.com, or follow them on X, Facebook, and LinkedIn.

Femasys Inc.

Nasdaq:FEMY

FEMY Rankings

FEMY Stock Data

26.35M
22.23M
7.62%
7.1%
2.23%
Medical Instruments & Supplies
Surgical & Medical Instruments & Apparatus
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United States of America
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