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Femasys Inc. Receives U.S. FDA Clearance to Market FemaSeed, an Innovative Infertility Treatment Solution
- The 510(k) Clearance from the United States Food and Drug Administration (FDA) allows for the U.S. commercialization of FemaSeed®, an intratubal artificial
About this update from Femasys Inc.
[{"type":"text","content":"- The 510(k) Clearance from the United States Food and Drug Administration (FDA) allows for the U.S. commercialization of FemaSeed®, an intratubal artificial insemination option designed to augment the natural fertilization process - - FemaSeed® is an innovative infertility treatment designed to deliver sperm directly to where conception occurs in a woman’s fallopian tube - ATLANTA, Sept. 25, 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 diagnostic products, today announced it has received 510(k) Clearance from the United States Food and Drug Administration (FDA) for FemaSeed®, an innovative infertility treatment designed to deliver sperm directly to where conception occurs in a woman’s fallopian tube. In recent decades, infertility has affected an increasing number of women – estimated at 10 million in the United States according to the Center for Disease Control (CDC). Despite incremental advancements, there have been no recent meaningful affordable options. FemaSeed® Intratubal Insemination is a type of an intrauterine insemination procedure that is less invasive than in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), which we expect would reduce the chances of procedural complications. “We are thrilled to receive 510(k) Clearance from FDA for FemaSeed®, an innovative infertility treatment designed to deliver sperm directly to where conception occurs,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “This FDA 510(k) Clearance of FemaSeed demonstrates our successful collaborative efforts with the FDA to bring forward new technology that will address the significant unmet need for less burdensome infertility treatments.” Femasys is creating accessible 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 manufacturing capabilities, with regulatory approvals in the U.S., Canada and other countries out...