Sam Brusco, Associate Editor09.26.23
Femasys has received U.S. Food and Drug Administration (FDA) 510(k) clearance for FemaSeed, an infertility treatment that delivers sperm directly to where conception occurs in the fallopian tube.
FemaSeed intratubal insemination is a type of intrauterine insemination procedure that’s less invasive than in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). Femasys expects the less invasive FemaSeed treatment will help lower the risk 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,” Femasys founder, president, and CEO Kathy Lee-Sepsick told the press. “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’ lead product candidate Fembloc, a form of permanent birth control, is in late-stage clinical development.
The FemaSeed procedure works together with FemVue, the company’s FDA-cleared diagnostic device for in-office ultrasound assessment of the fallopian tubes. It aims to offer an infertility diagnosis before FemaSeed.
Lee-Sepsick continued, “In recent years, there has been a sharp decline in fertility rates with a downward trajectory of sperm counts and record low birth rates. At this critical time, we are incredibly gratified that women and couples in the United States struggling with infertility will now have access to a new cost-effective infertility treatment option, in addition to the diagnostic solutions we have already made available.”
FemaSeed intratubal insemination is a type of intrauterine insemination procedure that’s less invasive than in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). Femasys expects the less invasive FemaSeed treatment will help lower the risk 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,” Femasys founder, president, and CEO Kathy Lee-Sepsick told the press. “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’ lead product candidate Fembloc, a form of permanent birth control, is in late-stage clinical development.
The FemaSeed procedure works together with FemVue, the company’s FDA-cleared diagnostic device for in-office ultrasound assessment of the fallopian tubes. It aims to offer an infertility diagnosis before FemaSeed.
Lee-Sepsick continued, “In recent years, there has been a sharp decline in fertility rates with a downward trajectory of sperm counts and record low birth rates. At this critical time, we are incredibly gratified that women and couples in the United States struggling with infertility will now have access to a new cost-effective infertility treatment option, in addition to the diagnostic solutions we have already made available.”