Femasys Announces Notices of Intention to Grant for Two New European Patent Applications Covering Use of FemBloc Permanent Birth Control

Rhea-AI Summary

Femasys (NASDAQ: FEMY) announces the European Patent Office's intention to grant two EU Patent Applications (24170531.8 and 18751753.7) for its FemBloc permanent birth control technology. The patents, expiring in 2039 and 2038 respectively, cover essential components of FemBloc's fallopian tube occlusion system, which provides a non-surgical alternative to traditional sterilization.

The company plans to pursue additional patent applications to strengthen its portfolio, which includes other products like FemaSeed, FemVue, FemCath, and FemCerv. This patent expansion in Europe precedes commercial availability and supports Femasys' mission to provide accessible women's health technologies globally.

Positive

• Secured two new European patents for FemBloc technology
• Patents provide protection until 2038/2039
• Expanding intellectual property coverage in European market ahead of commercialization

Negative

• Product not yet commercially available in Europe

European patents expand coverage for both essential components of FemBloc for fallopian tube occlusion, resulting in non-surgical permanent contraception

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: 
IR@femasys.com

Media Contact: 
Media@femasys.com

FAQ

What new patents did Femasys (FEMY) receive for FemBloc in Europe?

Femasys received notices of Intention to Grant for two EU Patent Applications (24170531.8 and 18751753.7) from the European Patent Office, covering essential components of FemBloc permanent birth control technology.

When do Femasys's new European patents for FemBloc expire?

The new European patents for FemBloc have anticipated expiration dates in 2039 and 2038.

What products are included in Femasys's (FEMY) current portfolio?

Femasys's portfolio includes FemBloc permanent birth control, FemaSeed, FemVue, FemCath, and FemCerv.

How does FemBloc differ from traditional sterilization methods?

FemBloc is a non-surgical permanent birth control alternative to traditional surgical sterilization, which is described as costly, inconvenient, and carrying significant risks.