Business
Femasys Inc. Completes Enrollment of FemaSeed Pivotal Trial in Support of Commercial Launch
- Topline results from FemaSeed® pivotal trial expected in 1H 2024 - - Commercial launch planned for early 2024 - ATLANTA, Nov. 28, 2023 (GLOBE NEWSWIRE) --
About this update from Femasys Inc.
[{"type":"text","content":"- Topline results from FemaSeed® pivotal trial expected in 1H 2024 - - Commercial launch planned for early 2024 - ATLANTA, Nov. 28, 2023 (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 completion of enrollment in the LOCAL FemaSeed® pivotal clinical trial, designed to evaluate women undergoing FemaSeed cycles due to male factor infertility. FemaSeed, an intratubal insemination approach that delivers sperm to the fallopian tube where conception occurs is now readying for commercialization. This pivotal trial was ongoing at the time of receiving both a 510K clearance from the Food and Drug Administration (FDA) in September 2023 and an approval from Health Canada in April 2023. “We are pleased to have completed enrollment for this important trial focused on low male sperm count, a challenging infertility factor for those trying to conceive, which is currently addressed by in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI),” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “FemaSeed may bring an option to those unable to pursue IVF or ICSI likely due to the financial and emotional burdens. Commercializing FemaSeed is part of Femasys’ mission to provide safe and accessible options to advance women’s health.” Femasys is creating accessible innovative options for women, as exemplified with FemaSeed, now an FDA-cleared infertility treatment and its lead product candidate FemBloc® in late-stage clinical development for permanent birth control. The Company is commercializing complementary diagnostic products that 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. About FemaSeed FemaSeed® is an innovative infertility treatment designed to deliver sperm locally and directly to the fallopian tube where conception occurs. It is intended to enhance natural fertilization and provide a first-line treatment option for infertility. The FemaSeed procedure works synergistically with FemVue®, Femasys’ FDA-cleared diagnostic de...