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QART Medical’s Q300™ First of a Kind Multi-Center Clinical Study Results – Published in Biomedicines Journal

QART Medical’s flagship product, the Q300™ was used in a first-of-its-kind multi-center clinical study, performed at four Israeli IVF clinics. Results of this study were recently published in Biomedicines titled, “Stain-Free Sperm Analysis and Selection for Intracytoplasmic Sperm Injection Complying with WHO Strict Normal Criteria.

This multi-center study evaluated the Q300’s accuracy of measurement and usability when employing quantitative phase microscopy (QPM) for label-free sperm-cell selection for intracytoplasmic sperm injection (ICSI). Senior embryologists were asked to select 11 apparently normal and 11 overtly abnormal sperm cells, in accordance with current clinical practice, using a micromanipulator and 60× bright field microscopy. Surprisingly, only 19% of the subjectively pre-selected “normal morphology” sperm cells were found to be in compliance with the consensus WHO2021 criteria, according to which, embryologists all over the world have been trained for decades.

These results highlight the potential for QART Medical’s Q300™ to revolutionize the field of reproductive medicine and allow clinicians to make evidence-based decisions, in real-time, for the benefits of patients and humanity.

QART Medical thanks our partners at the Meir, Barzilay, Shaarei-Tzedek, and Wolfson Medical centers. The article can be accessed at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10604130/

 

About QART Medical

QART Medical is an ISO13485 certified MedTech company addressing the global infertility epidemic. To do so, 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. The Q300™ is registered with the US FDA, has received Israeli regulatory registration for commercial sales, and is in the process of CE-Mark registration.