Oxidative stress is known to be a contributing factor to male infertility, though a significant amount of infertility cases remain unexplained. This is largely due to a lack of standardized tests to determine oxidative stress. A new clinical application called MiOXSYS®, however, is set to change that by assessing oxidative stress levels in semen as an aid in the diagnosis of male infertility. The platform is being developed by Aytu BioScience (OTCQX: AYTU), a leading pharmaceutical company focusing on the commercialization of innovative urology products. The company is currently pursuing regulatory approval for commercialization in the United States while boosting sales in other territories where the MiOXSYS® platform has already been approved. In December, Aytu signed a commercialization agreement with five leading medical distributors in Asia, targeting countries with significant market opportunities for male infertility technologies, including Japan, Korea, India, Hong Kong and Macau. More than 30 million cases of male infertility are reported across these five regions every year. Aytu is scheduled to present its operational results for the second quarter of fiscal 2017 on February 9. The company is expected to review recent accomplishments and provide an overview of its business and growth strategy, as well as its financial results for the fiscal quarter ended December 31, 2016.
To learn more, visit www.aytubio.com
About Aytu BioScience, Inc.
Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on global commercialization of novel products in the field of urology. The company currently markets three products: Natesto®, the first and only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or “Low T”), ProstaScint® (capromab pendetide), the only FDA-approved imaging agent specific to prostate specific membrane antigen (PSMA) for prostate cancer detection and staging, and Primsol® (trimethoprim hydrochloride), the only FDA-approved trimethoprim-only oral solution for urinary tract infections. Additionally, Aytu is developing MiOXSYS®, a novel, rapid semen analysis system with the potential to become a standard of care for the diagnosis and management of male infertility caused by oxidative stress. MiOXSYS is commercialized outside the U.S. where it is a CE Marked, Health Canada cleared product, and Aytu is conducting U.S.-based clinical trials in pursuit of 510k de novo medical device clearance by the FDA. Aytu’s strategy is to continue building its portfolio of revenue-generating urology products, leveraging its focused commercial team and expertise to build leading brands within well-established markets.
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