QART Medical, an ISO13485 certified MedTech company, is proud to announce the receipt of an approval to begin a new clinical study. This study will evaluate its FDA registered flagship product, the Q300™, in real-life conditions for the most commonly performed IVF procedures, Intra Cytoplasmic Sperm Injection (ICSI). The study is an open label, non-randomized, historical-control study, in which quantitative phase microscopy (QPM) will be used in a clinical setting to assist with an IVF procedure. The performance of the Q300™ was previously tested in a multi-center clinical study, which was recently completed to favorable results.
The approval was granted by Barzilai Medical Center, a pioneering clinical site in evaluating new clinical technologies, and is planned to enroll additional IVF sites.
“QART is excited to work with the talented and vibrant IVF team at Barzilai medical Center. We are eager to close the loop on the connection between morphological characteristics of sperm cells and clinical outcomes.” said Alon Shalev, CEO and Co-founder of QART Medical.
About QART Medical: QART Medical is a MedTech company addressing the global infertility epidemic. QART has developed the Q300™, a breakthrough solution to male infertility issues that provides a quantitative characterization of sperm cell morphology, to facilitate informed clinical decision making when selecting cells for use in in-vitro fertilization (IVF). QART aims to improve current success rates of Intra-Cytoplasmic Sperm Injection (ICSI) by quantitatively characterizing the morphology and composition of individual sperm cells with 3D topographic imaging.