Femasys Inc. received patent approvals for FemBloc® and plans to expand its patent portfolio in Europe.
Quiver AI Summary
Femasys Inc., a biomedical innovator focused on women's health, has received notices of intention to grant for two EU patent applications for its FemBloc® permanent birth control product from the European Patent Office. The patents, which are set to expire in 2039 and 2038, respectively, will bolster the company's intellectual property portfolio alongside other products like FemaSeed®, FemVue®, FemCath®, and FemCerv®. CEO Kathy Lee-Sepsick highlighted the significance of these patents in providing a non-surgical alternative to traditional sterilization methods, which are often costly and risky. Femasys is currently enrolling participants for a pivotal clinical trial for FemBloc in the U.S., with previous trials demonstrating its safety. The company aims to enhance access to essential healthcare technologies for women globally.
Potential Positives
- European Patent Office issued notices of intention to grant for two EU patent applications, extending protection for Femasys' innovative FemBloc permanent birth control product.
- FemBloc's advancement towards patent protection and commercialization represents a significant milestone in providing a non-surgical alternative to traditional sterilization methods.
- The expansion of Femasys' patent portfolio strengthens its competitive edge in the women's health market, allowing for broader market opportunities in Europe.
- Positive results from previous clinical trials demonstrate FemBloc’s safety, enhancing its potential acceptance and adoption in the market.
Potential Negatives
- The press release emphasizes the reliance on forward-looking statements, indicating potential uncertainties and risks that could significantly affect the company's future performance.
- Femasys is still in the process of enrolling participants for a pivotal clinical trial related to FemBloc, suggesting that the product has not yet completed the necessary steps for U.S. approval and market launch.
- The company references the need for additional patent applications, which may imply current concerns about the robustness of their intellectual property portfolio in a competitive market.
FAQ
What recent developments has Femasys announced?
Femasys announced that the European Patent Office intends to grant two patent applications related to its FemBloc permanent birth control product.
What is FemBloc and how does it work?
FemBloc is a non-surgical permanent birth control method that uses a minimally invasive delivery system to block fallopian tubes.
What are the benefits of FemBloc over surgical sterilization?
FemBloc offers a safe, accessible, and cost-effective option that avoids the risks and inconveniences associated with traditional surgical sterilization.
How is Femasys expanding its patent protection?
Femasys plans to pursue additional patent applications to strengthen its portfolio protecting FemBloc and other women’s health products.
Where can I find more information about Femasys products?
More information about Femasys and its products, including FemBloc, can be found on their official website at www.femasys.com.
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, Jan. 30, 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 European Patent Office (“EPO”) issued notices of Intention to Grant for two EU Patent Applications, EPO Application Nos. 24170531.8 and 18751753.7, which will have anticipated expirations in 2039 and 2038, respectively. Femasys plans to pursue additional patent applications to further strengthen its existing portfolio protecting FemBloc ® permanent birth control, along with its other products, including FemaSeed ® , FemVue ® , FemCath ® and FemCerv ® .
“The allowance of all requested claims for the two components of the non-surgical FemBloc permanent birth control marks a key milestone in extending protection for this revolutionary alternative to traditional surgical sterilization, which is costly, inconvenient, and carries significant risks,” stated Kathy Lee-Sepsick, Femasys’ CEO. “Expanding our patent protection and coverage in Europe ahead of commercial availability brings us one step closer to advancing Femasys' mission to deliver essential technologies to women globally.”
About FemBloc
FemBloc
®
is a revolutionary first-of-its-kind non-surgical permanent birth control, that involves a minimally invasive delivery system to introduce a specially designed blended polymer into the fallopian tubes, triggering a natural healing response that blocks the tubes with tissue in-growth. Designed for women seeking safe, accessible, and cost-effective permanent contraception, FemBloc avoids the risks and inconvenience of surgical sterilization. Participants are being enrolled in a pivotal clinical trial (NCT05977751) for U.S. approval. Previous clinical trials (NCT04273594, NCT03433911, and NCT03067272) have demonstrated FemBloc’s safety as a permanent birth control option compared to surgical sterilization. Learn more at
www.FemBloc.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 and Canada. FemVue
®
, a companion diagnostic for fallopian tube assessment via ultrasound, is U.S. FDA-cleared with approvals in Europe, Canada and Japan. FemCerv
®
, an endocervical tissue sampler for cervical cancer diagnosis, is U.S. FDA-cleared with approvals in Europe and Canada. 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 fourth 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
, or follow us on
X
,
Facebook
and
LinkedIn
.
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:
[email protected]
Media Contact:
[email protected]