Femasys receives Israeli regulatory approval for FemaSeed® and diagnostic devices FemVue® and FemCerv® in women's health.
Quiver AI Summary
Femasys Inc., a biomedical innovator focused on women's health, has received approvals from Israel's Medical Device Division for its FemaSeed® Intratubal Insemination product aimed at treating female infertility, as well as two diagnostic products, FemVue® for evaluating fallopian tubes and FemCerv® for detecting cervical cancer. CEO Kathy Lee-Sepsick emphasized the company's dedication to providing accessible and effective healthcare solutions for women globally, with Israel as a new market. FemaSeed offers a novel approach to artificial insemination, enhancing fertilization by delivering sperm directly into the fallopian tube. FemVue provides real-time evaluation of tubal health, while FemCerv enables painless cervical cancer screening. Femasys continues to expand its product reach in the U.S. and internationally, all while focusing on innovative, minimally invasive women’s health solutions.
Potential Positives
- The approval of FemaSeed® for female infertility treatment in Israel expands Femasys' market reach, potentially increasing sales and brand recognition in the region.
- FemVue® and FemCerv® approvals enhance Femasys' product portfolio in diagnostics, supporting comprehensive care in women's health.
- The innovations in their product suite highlight Femasys' commitment to providing accessible and effective healthcare solutions for women.
- The press release underscores significant FDA approvals and international acceptance of its products, reinforcing the company's credibility and competitive position in the market.
Potential Negatives
- Forward-looking statements highlight substantial risks and uncertainties surrounding the company's ability to successfully commercialize products, which may raise concerns among investors about future performance.
- The emphasis on international approvals could indicate limited domestic traction or market acceptance within the U.S., which might be interpreted as a lack of confidence in the products' success in the primary market.
- The statement about the pivotal trial for FemBloc is vague and may imply that the company is still reliant on ongoing clinical trials to validate product efficacy, posing a risk to overall growth and stability.
FAQ
What approvals did Femasys receive in Israel?
Femasys received approvals for FemaSeed® for infertility treatment and two diagnostic devices, FemVue® and FemCerv®.
How does FemaSeed® improve infertility treatment?
FemaSeed® enhances fertilization by delivering sperm directly into the fallopian tube, offering a more effective option for insemination.
What is the purpose of FemVue®?
FemVue® is used for real-time evaluation of fallopian tubes and is essential for assessing candidates for FemaSeed® treatment.
What is the significance of FemCerv®?
FemCerv® is designed for pain-free cervical cancer detection, allowing for uncontaminated sample collection in an office setting.
Where are Femasys products commercialized?
Femasys products are commercialized in the U.S. and select countries, including recent approvals in Israel.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$FEMY Hedge Fund Activity
We have seen 4 institutional investors add shares of $FEMY stock to their portfolio, and 8 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- CLEAR CREEK FINANCIAL MANAGEMENT, LLC removed 50,253 shares (-16.4%) from their portfolio in Q4 2024, for an estimated $55,278
- UBS GROUP AG added 21,353 shares (+inf%) to their portfolio in Q3 2024, for an estimated $23,701
- XTX TOPCO LTD added 18,004 shares (+123.9%) to their portfolio in Q3 2024, for an estimated $19,984
- GEODE CAPITAL MANAGEMENT, LLC added 17,473 shares (+9.2%) to their portfolio in Q3 2024, for an estimated $19,395
- TWO SIGMA SECURITIES, LLC removed 15,705 shares (-100.0%) from their portfolio in Q3 2024, for an estimated $17,432
- CREATIVE PLANNING removed 10,526 shares (-100.0%) from their portfolio in Q3 2024, for an estimated $11,683
- AVIOR WEALTH MANAGEMENT, LLC removed 4,311 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $4,742
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
ATLANTA, Feb. 04, 2025 (GLOBE NEWSWIRE) -- Femasys Inc., (Nasdaq: FEMY), a leading biomedical innovator addressing significant unmet needs in women's health worldwide, with a broad portfolio of disruptive, accessible in-office therapeutic and diagnostic products, announces the receipt of the Israeli Medical Device Division of the Ministry of Health’s (AMAR) approvals for the FemaSeed ® Intratubal Insemination product for female infertility treatment and two diagnostic devices, FemVue ® for tubal evaluation and FemCerv ® for cervical cancer detection.
“We remain committed to our mission of delivering critically important technological advancements to women globally, with Israel now added to our expanding reach.” stated Kathy Lee-Sepsick, Femasys’ CEO. “FemaSeed, along with our entire suite of products, has been developed to provide women with better, lower-cost and more accessible options. We remain focused on commercial execution in the U.S. and select other countries as we continue to expand the availability of our much-needed product solutions.”
About FemaSeed
FemaSeed
®
is an innovative advancement in artificial insemination, designed to enhance fertilization by precisely delivering sperm into the fallopian tube, the natural site of conception. It offers a safe, accessible and cost-effective first-line therapeutic option for infertile women, men and couples seeking pregnancy through insemination. FemaSeed offers a revolutionary alternative to IUI, enabling healthcare professionals to expand their practice services with a more effective approach as demonstrated in the pivotal trial (NCT0468847) for low male sperm count.
1
It serves as an affordable, less burdensome and lower-risk first step before IVF. Learn more at
www.femaseed.com
.
About FemVue
FemVue
®
is the first FDA-cleared product that creates natural saline and air contrast for a safe, reliable, real-time evaluation of the fallopian tubes using ultrasound. When combined with a uterine cavity assessment, it provides a comprehensive exam in the comfort of the gynecologist’s office. Since FemaSeed infertility treatment requires at least one open fallopian tube, FemVue is an essential companion diagnostic. Learn more at
www.femvue.com
.
About FemCerv
FemCerv
®
is the first and only FDA-cleared product purposefully designed to collect a comprehensive and uncontaminated sample in a pain-free office procedure for the detection of cervical cancer. Learn more at
www.femcerv.com
.
About Femasys
Femasys, an Atlanta-based leading biomedical innovator, develops and commercializes a portfolio of patent-protected, minimally invasive women’s health solutions, all manufactured in the U.S. Our innovative therapeutic and diagnostic products have received global regulatory approvals and are being commercialized in the U.S. and select countries. FemaSeed
®
Intratubal Insemination, a groundbreaking infertility treatment delivering sperm directly to the site of conception, is U.S. FDA-cleared and approved in Europe, Canada and Israel. FemVue
®
, a companion diagnostic for fallopian tube assessment via ultrasound, is U.S. FDA-cleared with approvals in Europe, Canada, Japan and Israel. FemCerv
®
, an endocervical tissue sampler for cervical cancer diagnosis, is U.S. FDA-cleared with approvals in Europe, Canada and Israel. FemBloc
®
permanent birth control, the Company’s late-stage product candidate, is the first and only non-surgical, in-office, method offering significant benefits over the costly, inconvenient, risk-laden surgical alternative. The pivotal clinical trial (NCT05977751) is now enrolling participants for U.S. approval. FemCath
®
and FemChec
®
, companion diagnostic products for FemBloc’s ultrasound-based confirmation test, are U.S. FDA-cleared and approved in Europe and Canada. Learn more at
www.femasys.com
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Reference
1
Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, K. Lee-Sepsick (2024). FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count.
J Gynecol Reprod Med
, 8(2), 01-12.
Forward-Looking Statements
This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “suggests,” “potential,” “hope,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to develop and advance our current product candidates and programs into, and successfully initiate, enroll and complete, clinical trials; the ability of our clinical trials to demonstrate safety and effectiveness of our product candidates and other positive results; estimates regarding the total addressable market for our products and product candidates; our ability to commercialize our products and product candidates, our ability to establish, maintain, grow or increase sales and revenues, or the effect of delays in commercializing our products, including FemaSeed; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law.
Contacts:
Investors:
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Media Contact:
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