INVO Bioscience said today it launched its InvoCell intravaginal culture infertility treatment system in the U.S., starting in Texas through the Center for Assisted Reproduction.
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. The company said it is the 1st intravaginal culture system with marketing clearance in the U.S.
“This seemingly simple device is truly a disruptive technology. The ability to grow embryos in the patient’s vaginal cavity rather than the large, complex expensive, intensive laboratory setting requiring 24/7 monitoring is tremendously advantageous. We can significantly lower the cost of delivering care by reducing both the need for expensive infrastructure as well as embryologist workload. We combine this with a reduced approach to medication and significantly streamlined monitoring and patient management systems that we call effortless IVF. In the future, we anticipate offering the INVO procedure in our effortless IVF facilities for approximately half the current cost of IVF care, with expected similar pregnancy rates to conventional IVF. This will increase the access to advanced fertility care as both geographic and financial barriers will be significantly diminished,” Center for Assisted Reproduction medical director Dr. Kevin Doody said in a press release.
The Medford, Mass.-based company said it won FDA de novo approval for its INVOcell last November. INVO Bioscience said that clinical studies of the INVOcell showed pregnancy rates equivalent to traditional in vitro fertilization treatments.
“There are an estimated 620,000 people who have sought fertility care in Texas last year and approximately 13,000 IVF procedures performed per year in the state. Under the banner of effortless IVF, INVO Bioscience and Dr. Kevin Doody will offer a significant value proposition to patients seeking fertility care in Texas. As more physicians are trained on the INVO Procedure, we estimate that over time there will be 10,000 INVO procedures performed per year in Texas. Vaginal culture using INVOcell will disrupt the status quo, delivering patients an alternate form of care that I am confident will appeal to a large segment of the U.S. population who face fertility challenges. INVO Bioscience is committed to rapidly delivering INVOcell through additional partnerships or arrangements and through our own corporate facilities across the U.S,” CEO Katie Karloff, CEO INVO Bioscience said in prepared remarks.