ATLANTA, May 07, 2024 (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, today announces the expansion of its commercial management team, marking a significant milestone in the company's mission to advance women's health worldwide. With the addition of new team members to its commercial team in key strategic geographical locations, Femasys is poised to fully initiate its strategic initiatives and execute on its delivery of innovative, accessible options to impact women’s healthcare.

The newly appointed team brings together seasoned professionals with a wealth of commercial experience across various sectors of the healthcare industry. Their collective expertise plays a pivotal role in driving Femasys' commercial efforts forward to realize the Company’s strategic vision, with initial emphasis on the Company’s infertility portfolio, led by the FemaSeed^® product.

"The formation of our commercial team with highly professional executives with a proven track record is a testament to Femasys' dedication to securing top talent to drive our sales & marketing initiatives forward with initial focus on our infertility portfolio," said Kathy Lee-Sepsick CEO of Femasys. "Their leadership and expertise will be instrumental in guiding Femasys as we continue to offer revolutionary products and expand our portfolio as we grow our reach to healthcare practitioners addressing women's healthcare needs. In April of this year, federal data revealed that birth rates in the U.S. reached a record low in 2023; we believe our FemaSeed approach has the potential to help those looking for infertility solutions as they navigate their reproductive journey.”

FDA-cleared FemaSeed is a revolutionary approach to enhancing natural fertilization, as a cost-effective primary therapeutic choice that stands to replace traditional intrauterine insemination (IUI) as the first step prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) given its significantly lower risks. Engineered to precisely deliver sperm into the fallopian tube, the site of conception, FemaSeed enables reliable and safe artificial insemination. With efficacy rates more than double historic IUI rates, specifically for male factor infertility (i.e., low sperm count), women and couples will now have an option that is cost affordable and less invasive than assisted reproductive procedures.

The commercial management team will begin concerted efforts during the esteemed 2024 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting, to be held in San Francisco’s Moscone Center May 17-19, 2024. This event serves as a platform for thought leaders, healthcare professionals, and industry stakeholders to convene and discuss the latest advancements in women's health. Femasys will be exhibiting at the conference at Booth #1413.

The 2024 ACOG meeting presents an ideal opportunity for Femasys to showcase the strength of its initial commercial team and its commitment to shaping the future of women's healthcare. Attendees can anticipate engaging discussions with Femasys' commercial executives, gaining insights into the company's broad portfolio of products, including commercially available FemVue^®, FemaSeed^®, and FemCerv^®, along with the late-stage clinical candidate, FemBloc^® for non-surgical permanent birth control.

About the American College of Obstetricians and Gynecologists

Founded in 1951, ACOG is the premier professional membership organization for obstetrician–gynecologists. The College produces practice guidelines for health care professionals and educational materials for patients, provides practice management and career support, facilitates programs and initiatives to improve women’s health, and advocates for members and patients.

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) or intracytoplasmic sperm injection (ICSI). FemaSeed received U.S. FDA clearance (September 2023) and regulatory approval in Canada (April 2023). 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 infertility (1 million to 20 million total motile sperm count (TMSC)). In this population, pregnancy rate was 24% by subject (n=42) and 16% by cycle (n=62) after FemaSeed. In contrast, the historical control described a 6.7% pregnancy rate by cycle for intrauterine insemination (IUI) with male factor (greater than 1 million TMSC).¹ This topline data provides strong support for FemaSeed’s value as the commercial team begins the market launch. Femasys successfully completed the first commercial procedure using its innovative FemaSeed intratubal insemination device in March 2024. 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. 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, and other ex-U.S. territories, and which are commercial-ready due to its in-house manufacturing capabilities. Its diagnostic products include FemVue^® 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. 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:
Gene Mannheimer
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Media Contact:
Kati Waldenburg
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