FEMY Femasys Inc

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 a partnership with HRC Fertility, one of the largest and most established providers of IVF and fertility services in the Western U.S. HRC Fertility will provide the Company’s FemaSeed Intratubal Insemination as an infertility treatment option to patients at its California locations.

“HRC Fertility’s endorsement underscores the recognition of FemaSeed’s value, as an efficacious and accessible first-line option for patients. We are thrilled to bring our next generation technology to patients in California through HRC Fertility, a world class IVF and fertility care provider. We look forward to expanding the availability of FemaSeed through additional partnerships to bring this vital first-line fertility treatment solution to women,” said Femasys CEO Kathy Lee-Sepsick.

FemaSeed delivers sperm directly and safely into the fallopian tube where conception occurs. It is intended to enhance natural fertilization and provide a first-line treatment option for those seeking pregnancy through artificial insemination. When compared to other reproductive technologies, FemaSeed demonstrated significantly higher efficacy as compared to historic intrauterine insemination for low male sperm count and is a safe, highly cost-effective option prior to in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI).

Dr. Bradford Kolb, President of HRC Fertility commented, “As a recognized leader in fertility services, HRC Fertility is constantly striving to advance our services and offer the latest innovations to our patients. FemaSeed is a progressive solution for the front end of care that will be a valuable addition to our suite of options, demonstrating our commitment to offer patients choices as they embark or continue their journey to parenthood.”

About FemaSeedFemaSeed® 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 to achieve pregnancy in couples with male-factor/ unexplained infertility and low male sperm count.1 Learn more at www.femaseed.com.

About FemasysFemasys 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.

About HRC FertilityHRC Fertility is one of the most established providers of advanced IVF and fertility care, boasting locations across Los Angeles, Orange, San Bernardino, and San Diego counties, with its San Francisco/Bay Area sites opening soon. Welcoming individuals, couples, and families from all walks of life, HRC Fertility is dedicated to helping its patients expand or build their families or preserve their family planning options for the future. The company was also recognized on Newsweek’s America’s Best Fertility Clinics 2023 list and the 2024 Healthcare Leadership Awards by the Los Angeles Business Journal. For detailed information about HRC Fertility’s services, locations, and providers, please visit www.HavingBabies.com

Reference1 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: Matt BlazeiIR@femasys.com 

Media Contact: Kati WaldenburgMedia@femasys.com