INVO Bioscience said yesterday it won FDA de novo approval for its INVOcell intravaginal culture infertility treatment system.
The company said it is the 1st intravaginal culture system with marketing clearance in the U.S.
INVOcell is designed for incubating eggs and sperm during fertilization during early embryo development and operates within a woman’s body, unlike in vitro fertilization which takes place in a laboratory, the company said.
“INVOcell has the ability to significantly transform the way in which fertility clinics across the United States assist infertile patients to achieve their desired outcomes in a simpler, more natural and cost effective manner. It has been a long process to de novo clearance and we are so pleased to have this approval from the FDA to begin marketing and selling in the United States. With this critical approval, we look forward to developing the partnerships necessary to bring this device to millions of patients across the United States,” CEO Katie Karloff said in a press release.
INVO Bioscience said that clinical studies of the INVOcell showed pregnancy rates equivalent to traditional in vitro fertilization treatments.
” My goal was to create an alternative treatment to traditional IVF procedures that could produce the desired results in a simpler and more cost effective manner to allow treatment to many more infertile couples. I believe the INVOcell procedure has the ability to significantly transform the way in which infertile couples go about achieving pregnancy. It is my hope that years from now it becomes the gold standard of use throughout the United States and the world. Based on current patient acceptance I think we are on the right track,” founder and prez Claude Ranoux said in a press release.