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 the onboarding of the first infertility medical clinic customers to offer its FemaSeed infertility treatment to patients in California and Florida.

“Femasys has begun partnering with infertility centers across the United States, enabling them to offer FemaSeed to their patients. We are excited to welcome Reproductive Fertility Center and Palm Beach Fertility Center as our first customers,” said Femasys CEO Kathy Lee-Sepsick. “We are enthusiastic about expanding FemaSeed’s availability and anticipate broader acceptance within the medical community as its distinct benefits gain wider recognition.”

FemaSeed is a unique form of artificial insemination because it delivers the sperm directly and safely into the fallopian tube on the side of ovulation. It is intended to enhance natural fertilization and provide a first-line treatment option for those seeking pregnancy. When compared to other reproductive technologies, such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI), it's a highly cost-effective and affordable procedure that is also safe and well-tolerated by patients.

Dr. Peyman Saadat, Reproductive Fertility Center in Los Angeles, California commented, “We look forward to providing our patients with another fertility treatment option, especially one that may provide benefit over IUI and is affordable for those struggling with financial constraints. We expect there to be growing interest once we begin to educate women about FemaSeed.”

Dr. David Kreiner, Palm Beach Fertility Center in Boca Raton, Florida said, “FemaSeed’s pregnancy success rate in its clinical trial shows a major improvement of this new treatment over traditional IUI using modern technology that can impact women fulfilling their fertility journey. We are thrilled to be at the forefront of providers offering FemaSeed.”

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 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 24% by subject (n=42) and 16% by cycle (n=62) 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 This topline data provides strong support for the on-going commercial launch, currently in progress. 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 Reproductive Fertility CenterUnder the guidance of Dr. Peyman Saadat, Reproductive Fertility Center continues to offer services to people who may have been turned away from other clinics. Our philosophy is to care for the whole patient, thereby reducing the impact that your treatment has on your everyday life. RFC offers comprehensive fertility treatments for both men and women, including IVF, egg donor cycles, surrogacy options, fertility preservation and more. Contact us at: 310.881.8846; www.reproductivefertility.com

About Palm Beach Fertility CenterAt Palm Beach Fertility Center, we provide individualized attention combined with state-of-the-art technology. Patients can rest assured they have access to the most advanced fertility treatments in our warm, supportive atmosphere. That’s why we continue to be a leader in providing top-tier fertility treatment services to patients not just from all over Florida, but across the globe, too. Numerous advances in clinical treatment and laboratory protocols have enabled us to maintain our high pregnancy rates and continue our quest to improve the quality of fertility treatment. Contact us at: 888.819.5177; www.palmbeachfertility.com

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