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 Boston IVF, one of the largest providers of fertility services in the U.S. Boston IVF will provide the Company’s FemaSeed intratubal insemination product as an infertility treatment option to patients throughout its network of locations in the U.S.

“We are elated to welcome Boston IVF, a prominent conglomerate in the infertility space, to our growing group of providers offering our FemaSeed treatment to their patients looking for fertility solutions,” said Femasys CEO Kathy Lee-Sepsick. “Our partnership with Boston IVF exemplifies our shared commitment to the expansion of infertility treatment options with groundbreaking technologies for women and couples. FemaSeed’s accessibility as an efficacious alternative to intrauterine insemination (IUI) and prior to in vitro fertilization (IVF) stands to enhance practice economics while satisfying the needs of patients particularly at the beginning of their journey.”

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 IVF and intracytoplasmic sperm injection (ICSI).

David Stern, CEO of Boston IVF commented, “As pioneers in reproductive healthcare and research, our team at Boston IVF is always looking for innovative technologies that expand choices and improve potential outcomes for our patients. We believe additional options are needed in infertility treatment and believe FemaSeed will be a valuable addition to our suite of patient options.”

Dr. Jamil Mroueh, reproductive endocrinologist with Boston IVF added, “I worked extensively with FemaSeed during our initial clinical evaluation and was consistently impressed with the ease of use and patient satisfaction to this new treatment. My patients expressed their excitement over FemaSeed as a new advancement and I believe we will be able to help more women now that we can provide this important treatment widely.”

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 healthcare professionals an ability to expand practice services 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) and regulatory approval in Canada (April 2023) and CE mark for Europe (June 2024). At the end of the fourth quarter of 2023, Femasys concluded a prospective, multi-center, unblinded pivotal clinical trial (NCT0468847) for those seeking intratubal insemination with FemaSeed. Adverse events were consistent with intrauterine insemination (IUI). Efficacy analysis focused on male factor (1 million to 20 million TMSC). In this population, pregnancy rate was 26.3% by subject (n=38) and 17.5% by cycle (n=57) after FemaSeed. In contrast, a 6.7% pregnancy rate by cycle was described in the literature for intrauterine insemination (IUI) with male factor (greater than 1 million TMSC).1 In market research of 1,000 infertile women, Femasys found that more than 7 in 10 women were extremely or very likely to consider insemination with FemaSeed; for those who received IVF, 88% would have preferred FemaSeed prior to moving on to IVF; and 85% who received IUI would have preferred FemaSeed instead of IUI. The topline data and market research provide strong support for the on-going commercial launch, currently in progress. 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.

About Boston IVF

Boston IVF is one of the largest and most experienced fertility networks in the United States, with more than 150,000 babies born since 1986. Founded as one of the nation's first private practice IVF centers, the Boston IVF network has grown to include 40 reproductive endocrinologists across nearly 30 centers throughout Massachusetts, Maine, New Hampshire, Rhode Island, New York, Delaware, Idaho, Indiana, North Carolina, Ohio, and Utah. A renowned innovator of reproductive technologies, advanced protocols, and cutting-edge research, Boston IVF has achieved numerous "firsts" in reproductive care. Its scientific and research arm continues to pave the way for breakthroughs in fertility care and its accredited REI Fellowship Program has graduated numerous reproductive endocrinologists as part of its mission to train the next generation of fertility experts. In 2024, Boston IVF joined the global IVI RMA Network, contributing to the network's management of more than 20+ labs and 60 satellites across North America. Contact us at: 888.300.BIVF; www.bostonivf.com

Reference

1. Duran et al. (2002) Intrauterine insemination: a systematic review on determinants of success. Human Reproduction, vol.8, no. 4, pp. 373-384.

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, 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