Aytu BioScience, Inc. (NASDAQ: AYTU) announced on 10/11/18 the issuance of a U.S. patent covering the company's proprietary MiOXSYS® diagnostic platform for male infertility. This is the first patent specifically covering fertility measurement methods with the MiOXSYS System and is the 15th U.S. patent overall covering the system's core oxidation-reduction potential (ORP) technology and its uses. The newly issued patent expires November 24, 2035.

U.S. Patent 10,088,466, entitled Determination of fertility potential from the oxidation-reduction potential of a biological sample, covers a method of determining characteristics of a semen sample via the measurement of static oxidation-reduction potential (sORP) of the semen sample from a subject in a specified ratio range of sORP to sperm concentration in a liquified semen sample. sORP, the diagnostic output of the MiOXSYS System and a direct measure of oxidative stress, serves as an aid in the diagnosis of male infertility in directly measuring oxidative stress in semen, the cause of DNA damage and a leading cause of male infertility.

Josh Disbrow, Chief Executive Officer of Aytu BioScience commented, "This patent issuance for the company's diagnostic platform is an important step in moving closer to U.S. commercialization and providing another approved, commercial-stage product to our established U.S. commercial infrastructure. This validation of our proprietaty oxidation-reduction potential technology helps to further unlock the potential of MiOXSYS and position it as a complement to Natesto® as the second urology-centric product in our portfolio. As we advance MiOXSYS toward a 510k de novo clearance in the U.S., we continue to demonstrate very good progress outside the U.S. as MiOXSYS sales build."

The global male infertility market is expected to reach $4.7 billion by 2025, and increasing infertility in men and advancements in diagnostic tests are expected to be key factors in driving this market growth.

MiOXSYS is currently commercialized through a distribution network outside the U.S. and has been sold into 29 countries to date. The company is conducting clinical studies with U.S. collaborators in order to establish a U.S. specific regulatory clearance pathway with the FDA.