viewAytu BioScience Inc

Aytu BioScience Inc gets approval for male infertility diagnostics

Aytu’s new urology product MiOXSYS, a system that assesses the level of oxidative stress in semen, can now be marketed in Canada.

It marks an early commercialisation milestone, as Aytu awaits US FDA approval.

Aytu Bioscience Inc (OTCMKT:AYTU) told investor it has received approval from Health Canada for its MiOXSYS System which is designed to aid diagnostics for male fertility.

MiOXSYS is an in vitro diagnostic platform that assesses the level of oxidative stress in semen, and the new Health Canada approval will allow Aytu to market the product in Canada.

The product is already cleared for sale in the European Union, following the granting of a CE mark in January, and the company recently made its first commercial sales in the Middle East.

Aytu said it would now also seek strategic opportunities to build partnerships with prominent hospitals, academic centers, and early MiOXSYS users in Canada.

American approval, via the US Food & Drugs Administration, is also being sought.

John Disbrow, Aytu chief executive, said: "Achievement of this milestone reflects our focus on commercializing best-in-class urology products and marketing those products strategically.

“As we pursue FDA clearance of MiOXSYS in the United States, we expect to benefit greatly from these early commercialization efforts in key markets.

“In Europe and the Middle East, our urology customers are already beginning to see the value of MiOXSYS, and this interest is being driven by the widespread need for improved diagnosis in the field of male infertility."

Quick facts: Aytu BioScience Inc

Price: 7.44 USD

Market: NASDAQ
Market Cap: $128.31 m

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