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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.

News

Femasys’ FemaSeed FDA Clearance Brings Timely Access to a First-Line Infertility Treatment Option as an Alternative to IVF

Rhea-AI Summary
Femasys prepares to launch FemaSeed® in the U.S. amidst legal uncertainty after Alabama Supreme Court ruling. The company plans to release top-line data from a pivotal clinical trial in Q1 2024. FemaSeed offers a cost-effective and safe alternative to traditional assisted reproductive methods, aiming to revolutionize fertilization.
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Femasys Inc. Advances Commercial Readiness with Appointment of Richard Spector to New Position of Chief Commercial Officer

Rhea-AI Summary
Femasys Inc. appoints Richard Spector as chief commercial officer to lead the commercial launch of FemaSeed, a novel solution for infertility, and FemBloc, a non-surgical permanent birth control. Mr. Spector brings 25 years of experience in leading public and private healthcare companies and will be granted 100,000 shares of Femasys common stock as an inducement for his employment.
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Femasys Inc. Begins FemBloc Pivotal Trial Enrollment at UC Davis Medical Center, a Hub for Innovation and Groundbreaking Research in Health Care for Women

Rhea-AI Summary
Femasys Inc. (NASDAQ: FEMY) announced the activation of enrollment for its pivotal FemBloc trial at the University of California, Davis Medical Center. The trial aims to investigate the safety and efficacy of FemBloc, a non-surgical, permanent birth control candidate. This marks the third academic center to participate in the trial, with Dr. Mitchell Creinin as an initial advisor. The trial is designed to address the high unmet need for women seeking permanent birth control, for whom elective surgery remains the only option. Femasys is focused on creating accessible innovative options for women, with a broad portfolio of in-office, accessible solutions and late-stage clinical development for permanent birth control.
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Femasys Inc. Begins FemBloc Pivotal Trial Enrollment at University of Utah, an Internationally Recognized Center in Obstetrics and Gynecology

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Femasys Inc. announces the activation of enrollment for its pivotal FemBloc trial at the University of Utah Hospital, led by Dr. Lori Gawron, M.D. The trial is designed to investigate the safety and efficacy of FemBloc, a non-surgical permanent birth control solution. The company is focused on providing accessible solutions for women worldwide, with a broad portfolio of products in late-clinical stage development and FDA-cleared products. The involvement of University of Utah Hospital and Dr. Gawron demonstrates support for FemBloc and its potential to provide improved birth control options for women.
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Femasys Inc. Begins FemBloc Pivotal Trial Enrollment at Stanford Medicine

Rhea-AI Summary
Femasys Inc. (NASDAQ: FEMY) has activated enrollment for its pivotal FemBloc® trial at Stanford Medicine to investigate the safety and efficacy of its investigational permanent birth control candidate, FemBloc. The trial aims to address the high unmet need for women seeking permanent birth control, for whom elective surgery currently remains the only option. Femasys is focused on creating accessible innovative options for women, exemplified by its lead product candidate, FemBloc, and its FDA-cleared product, FemaSeed®, for infertility treatment.
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Femasys Inc. Announces the Appointment of James Liu, M.D., as Chief Medical Officer

Rhea-AI Summary
Femasys Inc. (NASDAQ: FEMY) appoints Dr. James Liu, M.D., a renowned figure from a top-ranked academic gynecology program, as Chief Medical Officer. Dr. Liu's appointment comes as Femasys accelerates the commercialization of its product pipeline, including a new therapeutic for artificial insemination, FemaSeed®. With significant clinical and leadership experience, Dr. Liu is expected to support Femasys' efforts in reproductive health and product development.
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Femasys Inc. Completes Enrollment of FemaSeed Pivotal Trial in Support of Commercial Launch

Rhea-AI Summary
Femasys Inc. (FEMY) completes enrollment in the LOCAL FemaSeed® pivotal clinical trial for male factor infertility, with commercial launch planned for early 2024. The company's lead product candidate FemBloc® is in late-stage clinical development for permanent birth control. FemaSeed, an FDA-cleared infertility treatment, aims to provide accessible options for women's health. The company also focuses on developing complementary diagnostic products with regulatory approvals in the U.S., Canada, and other ex-U.S. territories.
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PharmaCyte Biotech Acquires $5 Million Stake in Emerging Women’s Health Innovator Femasys, Inc.

Rhea-AI Summary
PharmaCyte Biotech, Inc. (Nasdaq: PMCB) announces a $5 million investment in Femasys, Inc. (Nasdaq:FEMY), marking an expansion of its corporate strategy to create additional shareholder value. The investment aims to utilize PharmaCyte's significant cash position and contribute to Femasys' development of innovative women's health solutions, including a non-surgical, in-office permanent birth control method.
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Femasys Inc. Secures Additional Financing with Strategic Investment from Investors led by PharmaCyte Biotech

Rhea-AI Summary
Femasys Inc. (NASDAQ: FEMY) secured a $6.85 million upfront investment from PharmaCyte Biotech, Inc. and other healthcare investors, providing a total cash runway of $23 million until the second half of 2025. This investment will support the commercialization of infertility-related products and the advancement of FemBloc, Femasys' lead product candidate for permanent birth control, to initial clinical data readout. The investment is in the form of a senior unsecured convertible note and includes warrants to purchase approximately 5.8 million shares of common stock at varying exercise prices.
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Femasys Inc. Announces Financial Results for the Third Quarter Ended September 30, 2023 and Provides Corporate Update

Rhea-AI Summary
Femasys Inc. (Nasdaq: FEMY) gained 510(k) product clearance for FemaSeed, commenced patient enrollment in the FINALE trial for FemBloc, and raised $11.3 million. The company also achieved compliance with Nasdaq's minimum bid price requirement and announced financial results for Q3 2023.
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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.

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Femasys Inc.

Nasdaq:FEMY

FEMY Rankings

#5201 Ranked by Market Cap
N/A Ranked by Dividends

FEMY Stock Data

25.62M
21.20M
7.62%
7.26%
2.37%
Medical Instruments & Supplies
Surgical & Medical Instruments & Apparatus
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