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Femasys Inc. Announces Financial Results for the Second Quarter Ended June 30, 2022 and Provides Corporate Update
Continued focus and progress with FemaSeed® and FemBloc® biomedical product candidates in developmentFemCerv® and FemCath™ commercial availability expected by
About this update from Femasys Inc.
[{"type":"text","content":"Continued focus and progress with FemaSeed® and FemBloc® biomedical product candidates in developmentFemCerv® and FemCath™ commercial availability expected by year-end ATLANTA, Aug. 10, 2022 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company aiming to meet women's needs worldwide by developing a suite of product candidates that include minimally invasive, in-office technologies for reproductive health, today announced financial results for the second quarter and six months ended June 30, 2022 and provided a corporate update. “The decision this past quarter announcing the overturn of the landmark Roe v. Wade case underscores the importance for women to have access to reproductive health options that are safe and reliable, which strongly coincides with Femasys’ mission,\" said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “Now, more than ever, advanced and modernized reproductive health solutions, like those we are developing for women, are of paramount importance as options for family planning. Safety and choice have always been core drivers in our mission to develop non-surgical solutions for women around the world. FemBloc® is the only permanent birth control alternative in development designed with accessibility and affordability in mind to provide a non-surgical tubal occlusion option to women.” Second Quarter and Recent Developments Related to Clinical Programs FemBloc On July 28, 2022, Femasys hosted a Key Opinion Leader (KOL) event in the wake of the overturn of Roe v. Wade, to discuss FemBloc. The webinar featured a presentation from KOL, Paul D. Blumenthal, MD, MPH, Professor of Obstetrics and Gynecology of The Stanford University Medical Center and discussion of the unmet need for women seeking permanent birth control options. Femasys remains on track to complete enrollment for its Stage 2 study of FemBloc in the third quarter and file an Investigational Device Exemption (IDE) for a pivotal trial to support a Pre-Market Authorization (PMA) in the first quarter of next year. FemaSeed An interim analysis for the FemaSeed LOCAL de novo pivotal trial is planned for the fourth quarter of this year. The trial is being conducted across centers in the United States and is expected to enroll up to 792 patients who are diagnosed as infertile. The primary endpoints of the study ar...