Femasys Announces Notice of Allowance for New U.S. Patent Application Covering Use of FemaSeed® for Female Infertility Treatment

FemaSeed^® patent application provides additional coverage for Femasys’ therapeutic option for women seeking infertility solution

ATLANTA, Jan. 16, 2025 (GLOBE NEWSWIRE) — Femasys, Inc., (Nasdaq: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, announces the United States Patent and Trademark Office (“USPTO”) issued a Notice of Allowance for U.S. Patent Application 18/443,798 further strengthening Femasys’ intellectual property position and coverage for the Company’s infertility therapeutic product FemaSeed^® Intratubal Insemination.

Femasys expects the resulting patent, when issued, will have an anticipated expiration in 2044 at the earliest. Femasys intends to continue to prosecute additional patent applications to further enhance its existing patent portfolio protecting FemaSeed^® along with FemBloc^® permanent birth control, the Company’s late-stage product candidate, in addition to the Company’s other existing available diagnostic products, FemVue^®, FemCath^®, and FemCerv^®.

“The allowance of claims for the FemaSeed infertility treatment is another important milestone in extending protection for this revolutionary infertility solution for women and couples seeking assistance in becoming pregnant, which is currently being marketed in the U.S. and Spain,” stated Kathy Lee-Sepsick, Femasys’ CEO. “Expansion of our patent portfolio, which consists of over 180 patents globally, demonstrates our strong commitment to protecting the innovation and commercial opportunity of FemaSeed, as well as our entire suite of products for women seeking better, lower cost, and more accessible options.”

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 is intended to be a first-line therapeutic choice for infertile women, men, and couples seeking pregnancy through insemination, offering a safe, accessible, and cost-effective approach. FemaSeed^® is a revolutionary device that allows for the expansion of practice services by enabling healthcare professionals with a more affordable and safer alternative to assisted reproductive methods, such as in vitro fertilization (IVF). FemaSeed received U.S. FDA clearance (September 2023), regulatory approval in Canada (April 2023) and CE mark for Europe (June 2024). At the end of 2023, Femasys concluded a prospective, multi-center, pivotal clinical trial (NCT0468847) for those seeking intratubal insemination with FemaSeed. Positive data was published demonstrating FemaSeed as a safe and effective treatment option, with significantly higher efficacy as compared to historic intrauterine insemination for couples with male-factor/ unexplained infertility and low male sperm count.¹ Learn more at www.femaseed.com.

About Femasys
Femasys is a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic solutions, including a lead revolutionary product candidate and FDA-cleared products. FemaSeed^® Intratubal Insemination, an innovative infertility treatment designed to deliver sperm directly where conception occurs, is FDA-cleared and has received regulatory approval in Canada and Europe. FemBloc^® permanent birth control in late-stage clinical development is the first and only non-surgical, in-office, permanent birth control method intended to be a safer option for women at substantially less cost than the long-standing surgical alternative. The Company has developed diagnostic products that are complementary for which it has achieved regulatory approvals to market in the U.S., Canada, Europe, and other ex-U.S. territories, and which are commercial-ready due to its in-house manufacturing capabilities. Its diagnostic products include FemVue^® and FemVue^® MINI for fallopian tube assessment by ultrasound, which can be used in conjunction with FemCath^®, an intrauterine catheter for selective fallopian tube evaluation, and FemCerv^®, an endocervical tissue sampler for cervical cancer diagnosis. Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.

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: 
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Media Contact: 
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