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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.

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Femasys successfully completes the Stage 2 EU Medical Device Regulation audit, paving the way for CE marking and product distribution in the European Union market.
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Femasys Inc. will showcase its product candidate FemBloc® and three marketed products at the annual meeting of the American Association of Gynecologic Laparoscopic Surgeons (AAGL). The company is focused on meeting unmet needs for women with innovative solutions.
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Femasys regains compliance with NASDAQ listing standards
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Femasys Inc. will be exhibiting at the ASRM annual meeting to showcase its reproductive portfolio, including FemaSeed® and diagnostic products. FemaSeed® received FDA clearance for U.S. commercialization last month. Femasys is also developing FemBloc® for permanent birth control. The Company has regulatory approvals in the U.S., Canada, and other territories.
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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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FAQ

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

The current stock price of Femasys (FEMY) is $1.09 as of December 20, 2024.

What is the market cap of Femasys (FEMY)?

The market cap of Femasys (FEMY) is approximately 25.6M.

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

25.62M
21.20M
7.62%
7.26%
2.37%
Medical Instruments & Supplies
Surgical & Medical Instruments & Apparatus
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United States of America
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