Femasys Inc FEMY shares surged after the company received FDA 510(k) clearance for FemaSeed, an infertility treatment designed to deliver sperm directly to where conception occurs in a woman's fallopian tube.
Infertility has affected an increasing number of women – estimated at 10 million in the U.S., according to the Center for Disease Control.
FemaSeed Intratubal Insemination is an intrauterine insemination procedure less invasive than in vitro fertilization or intracytoplasmic sperm injection, which is expected to reduce the chances of procedural complications.
Femasys is creating accessible options for women, 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.
The FemaSeed procedure works synergistically with FemVue, Femasys' FDA-cleared diagnostic device that enables an in-office ultrasound assessment of the fallopian tubes and serves to provide an infertility diagnosis before FemaSeed.
Price Action: FEMY shares are up 243.8% at $1.14 during the premarket session on the last check Tuesday.
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