• UC Davis Medical Center, a top regional and nationally ranked medical center, is the third academic center to participate in the FemBloc pivotal trial since enrollment began last quarter
• UC Davis Professor of the Obstetrics and Gynecology (OB/GYN) Department and Director of the Complex Family Planning Fellowship, Mitchell Creinin, M.D. has been an initial advisor for FemBloc
• FemBloc is being developed as a first-of-its-kind, non-surgical, permanent birth control with a clearly defined U.S. regulatory pathway

ATLANTA, Jan. 26, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead, late-clinical stage product candidate and innovative therapeutic and diagnostic products, today announced that it has activated enrollment for its pivotal FemBloc^® trial at University of California, Davis (“UC Davis”) Medical Center in Sacramento, California. The FemBloc Intratubal Occlusion for TranscervicAL Permanent Birth Control (the “FINALE” trial) is being conducted to investigate the safety and efficacy of its investigational permanent birth control candidate, FemBloc^®. The FDA-approved, multi-center trial is designed to address the high unmet need that exists for women seeking permanent birth control, for whom elective surgery currently remains the only option.

Femasys is creating accessible innovative options for women, as exemplified by its lead product candidate, FemBloc^®, in late-stage clinical development for permanent birth control, and its United States Food and Drug Administration (FDA)-cleared product, FemaSeed^®, for infertility treatment that is also approved in Canada. The Company is also commercializing complementary diagnostic products, FemVue^®, FemCath^® and FemCerv^®, all of which were internally developed through its in-house R&D and manufacturing capabilities, with regulatory approvals in the U.S., Canada and other ex-U.S. territories.

“UC Davis Medical Center, a nationally renowned medical center, is another great addition to the clinical trial sites participating in this initial phase of the FINALE trial, as Dr. Mitchell Creinin has been a long-time supporter of our new permanent birth control option,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “Dr. Creinin, a highly published researcher in the field of gynecology with a focus on family planning, brings decades of experience to contribute to the pivotal trial at this important stage of development for FemBloc.”

“I am excited to participate in this important trial to progress this much needed, non-surgical permanent birth control option for women,” commented Dr. Creinin. “I believe that this may be an ideal solution for those seeking an accessible, safe, less financially and emotionally burdensome option to address a basic healthcare need for family planning.”

About UC Davis Medical Center

UC Davis Medical Center is a comprehensive academic medical center where clinical practice, teaching and research converge to advance human health. The medical center serves a 33-county, 65,000-square-mile area that stretches north to the Oregon border and east to Nevada. It further extends its reach through the award-winning telemedicine program, which gives remote, medically underserved communities throughout California unprecedented access to specialty and subspecialty care. For more information, visit https://medicalcenter.ucdavis.edu.

About FemBloc

FemBloc^® is a first-of-its-kind, non-surgical, non-implant, in-office solution in late-stage clinical development for permanent birth control. It is intended to be a safer option for women and its cost is estimated to be substantially less than the long-standing surgical alternative by eliminating the need for anesthesia, incisions, and permanent implants. FemBloc has the potential to offer a convenient, accessible, and reliable option to women seeking permanent birth control. For over 100 years, there has been stagnant innovation in the area of permanent birth control; this could lead to a $20 billion market expansion opportunity for FemBloc in the U.S. alone. For more information, visit www.FemBloc.com.

About the FINALE Pivotal Clinical Trial at UC Davis Medical Center

If interested in learning more about study participation at UC Davis Medical Center, visit the UC Davis study website or call 916-734-6846.

About the FINALE Pivotal Clinical Trial

Femasys ‘FINALE [Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control] trial (NCT05977751) is designed as a prospective, multi-center, open-label, single-arm study to evaluate the safety and efficacy of FemBloc, a novel, non-surgical female permanent birth control approach. The primary endpoint is pregnancy rate, which will be analyzed once 401 women have used FemBloc for one year for permanent birth control. The trial is designed as a roll-in beginning with enrollment of 50 women for a clinical readout primarily of preliminary safety data prior to enrolling the remaining subjects. An interim analysis of clinical data endpoints is planned once 300 women have used FemBloc for one year. Follow-up will continue annually for five years post-market. For more information, visit www.FemBloc.com.

About Femasys

Femasys is a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead revolutionary late-clinical stage product candidate and FDA-cleared, innovative therapeutic and diagnostic products. Femasys’ 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. Femasys’ FemaSeed^® Intratubal Insemination, an innovative infertility treatment designed to deliver sperm directly where conception occurs, is now FDA-cleared and has received regulatory approval in Canada. 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. The Company’s 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.

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,” “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 product candidates; our ability to commercialize our product candidates, or the effect of delays in commercializing; 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, 2022 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. 

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