Femasys Inc. Begins FemBloc Pivotal Trial Enrollment at University of Utah, an Internationally Recognized Center in Obstetrics and Gynecology

2024-01-23

临床研究

- University of Utah Hospital, Lori Gawron, M.D. of the Obstetrics and Gynecology (OB/GYN) Department, was an instrumental investigator in Femasys’ earlier FemBloc study - - FemBloc is being developed as a first-of-its-kind, non-surgical permanent birth control with a clear U.S. regulatory pathway - ATLANTA, Jan. 23, 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 another academic site, University of Utah Hospital in Salt Lake City, Utah. 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 help 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. “As we continue to advance the FINALE trial for FemBloc, we are thrilled to partner with the University of Utah Hospital, recognized for their global expertise in the specialty and sub-specialties of obstetrics and gynecology, and, in particular to have the involvement of Dr. Gawron, M.D., Associate Professor of Obstetrics and Gynecology, given her dedication to the field of gynecology and history with FemBloc,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “Dr. Gawron’s consistent involvement demonstrates support for FemBloc and the importance that it may hold in providing optionality to women seeking additional and improved birth control options." Dr. Lori Gawron, M.D. added, “It was my explicit goal to ensure University of Utah Hospital would be an early participant in the FINALE trial at this crucial time for women who today struggle with access and limited choices, particularly for those seeking a permanent birth control solution. An in-office option like FemBloc has the opportunity to change how we deliver care to women when they no longer wish to be at risk of pregnancy but no longer want exposure to hormones or implants or surgery.” About University of Utah Hospital The Department of Obstetrics and Gynecology at the University of Utah is recognized internationally for excellence in clinical care, medical education, and research. The physicians and staff provide world-class expertise in the specialty and sub-specialties of obstetrics and gynecology. 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 . 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 , 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. Contacts: Investors Chuck Padala LifeSci Advisors, LLC 917-741-7792 chuck@lifesciadvisors.com Femasys Inc. Investor Contact: IR@femasys.com Media Contact: Media@femasys.com