Aytu BioScience, Inc., a specialty healthcare company focused on commercialising treatments for urological and related conditions, announced that it has obtained CE Marking in Europe for its MiOXSYS System. MiOXSYS is the company’s in vitro diagnostic platform for assessing the level of oxidative stress in semen as an aid in the diagnosis of infertility in males. This regulatory clearance positions Aytu for a launch in Europe and other markets and expands Aytu’s portfolio of marketed products including ProstaScint and Primsol.
Josh Disbrow, chief executive officer of Aytu, stated, “Aytu is building a portfolio of specialized products focused on the urology market, and we aim to serve a large area of medical need with the launch of MiOXSYS. We expect MiOXSYS to be a valuable product for our urology customers given the widespread need for improved diagnosis in the field of male infertility, which accounts for approximately 40-50 per cent of all infertility cases in the US and Europe. Semen analysis studies are already routinely conducted around the world to assess causes of infertility, and these studies often include oxidative stress assessments. Additionally, antioxidant supplementation is frequently recommended to patients by clinicians without an effective method of measuring treatment success. Now with the availability of MiOXSYS, we expect clinicians to integrate MiOXSYS into routine assessment of infertility status and monitoring of treatment effects. We look forward to launching this novel product in Europe while seeking Food and Drug Administration (FDA) approval in the United States.”
A significant proportion of male infertility remains unexplained in part because of the lack of standardized tests available to clinicians and researchers to assess oxidative stress, which is well established as a leading contributing factor to idiopathic male infertility. This lack of standardization has resulted in poor implementation of semen and plasma analysis around the world.
Aytu has conducted clinical studies in male infertility with a leading center in the United States and determined that oxidation-reduction potential, the key parameter reported by the MiOXSYS system, effectively measures oxidative stress levels in semen and seminal fluid. Additional studies are now underway in the US and around the world that will determine the MiOXSYS system’s performance in semen analysis as it relates to a broad range of uses in male infertility. The company expects to initiate clinical trials in the United States to enable submission of MiOXSYS to the FDA.