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Femasys Inc. Announces Enrollment is over 25% Complete for FemaSeed® De Novo Trial Following Updated Strategic Study Design
--FemaSeed de novo trial enrollment has accelerated with trial recruitment focus on male factor infertility-- ATLANTA, Nov. 29, 2022 (GLOBE NEWSWIRE) --
About this update from Femasys Inc.
[{"type":"text","content":"--FemaSeed de novo trial enrollment has accelerated with trial recruitment focus on male factor infertility--\nATLANTA, Nov. 29, 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 that it has completed over 25% of its targeted enrollment (214 patient fertility cycles) in its FemaSeed® de novo trial. FemaSeed is the first and only first-line approach in development designed to deliver sperm directly to where conception occurs. FemaSeed is a localized artificial insemination option that is also designed to be more affordable than assisted reproduction, such as in vitro fertilization (IVF). “Our strategy to focus on male factor infertility, where we believe FemaSeed could have the greatest impact, is proving to be a sound strategy as we expedite advancement of this clinical program,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “After announcing our updated strategic trial design only a month ago, we are thrilled to have reached over 25% of our targeted 214 FemaSeed cycles. Since it is estimated that 50% of all infertility cases can be attributed to male factor infertility, the Company believes that its FemaSeed product candidate could significantly benefit this population. We are proud to have hit multiple company milestones – both this quarter and last – and maintain continued momentum on all fronts with a strengthened management team as we advance our other programs: preparing for a pivotal study of FemBloc® for permanent birth control followed by a confirmation test with FemChec® early next year, and readying FemCath™ for the commercial marketplace before year end as well.” About the De Novo Trial for FemaSeed The FemaSeed LOCAL de novo clinical trial is a prospective multi-center, unblinded study (NCT04968847) being conducted across centers in the United States requiring evaluation of up to 214 women undergoing 214 FemaSeed cycles due to male factor infertility. The primary endpoints of the study are to determine the effectiveness (pregnancy rate) and safety over a period of seven weeks post-FemaSeed procedure. In October, the Company announced an updated study design for this trial, which...