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Irvine Scientific Receives FDA Clearance For Vit Kit-Freeze, Vit Kit-Thaw

Irvine Scientific, a developer of products specifically for the assisted reproductive technology (ART) community, has received FDA approval for its products intended for vitrification of pronuclear (PN) zygotes through day 3 cleavage and blastocyst stage embryos within the fertility area.

The approval for both Vit Kit-Freeze and Vit Kit-Thaw allows users greater flexibility to vitrify specimens depending on the in-vitro fertilization (IVF) laboratory’s protocol and their patients’ needs. Vitrification has enabled clinics to improve pregnancy rates over those of traditional slow cooling and also to move toward practicing Single Embryo Transfers when possible to reduce multiple pregnancies, and improve lab efficiency.

Tim Mullane, chief operating officer of Irvine Scientific, said: “We are pleased to be the first, and to-date, the only company that offers superior quality vitrification solutions for cryopreservation of all stages of embryos (PN through blastocyst stage) in the US. We hope with the addition of the expanded use for Vit Kit-Freeze and Vit Kit-Thaw, IVF clinics can offer better patient care.”