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Femasys Inc. Announces First Patient Treated in Pivotal Trial for FemaSeed
First in Class Insemination Treatment for Infertility LOCAL Pivotal Trial to Enroll Up to 792 Patients Across 20 U.S. Centers ATLANTA, July 20, 2021 (GLOBE
About this update from Femasys Inc.
[{"type":"text","content":"First in Class Insemination Treatment for Infertility LOCAL Pivotal Trial to Enroll Up to 792 Patients Across 20 U.S. Centers ATLANTA, July 20, 2021 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on transforming women's healthcare, today announced the initiation and first patient treated in a pivotal trial evaluating FemaSeed, a first in class, localized directional insemination product candidate for infertility. “For more than 20 years, current approaches to infertility treatment have been limited during the initial stage of therapeutic care, but with the advancement of FemaSeed, we believe a next generation intrauterine procedure may have the opportunity to truly change this traditional paradigm,” said Michael Glassner, MD, Founding Partner and Medical Director of Main Line Fertility & Reproductive Medicine in Pennsylvania, where the first patient in the LOCAL trial was treated in July 2021. “The LOCAL trial is the next step in proving the FemaSeed localized directional insemination approach. My colleagues and I are thrilled to be a part of this patient care evolution.” The LOCAL trial will be conducted across approximately 20 centers in the United States and is expected to enroll up to 792 patients diagnosed as infertile. The primary endpoints of the study are to determine the effectiveness (clinical pregnancy rate) and safety over a period of 7 weeks. “Infertility has become a global issue and the commencement of the LOCAL trial underscores our commitment to ensure that women struggling to become pregnant receive the best, lowest cost treatment option by developing our innovative directional delivery platform technology,” said Kathy Lee-Sepsick, founder, President & Chief Executive Officer of Femasys. About FemaSeedFemaSeed features intrauterine directional delivery that deposits sperm locally and directly to the fallopian tube where conception occurs. As the first and only approach, presenting significant advantages over existing artificial insemination solutions, it is intended to become a first-line treatment for infertility. About InfertilityInfertility is a major public health concern, with declining fertility levels and an increase in the number of countries experiencing a reduction in population size. In the United States alone, there are over 9 million women known to be infertile. First...