Aytu BioScience Announces First Commercial Sales for Company's MiOXSYS™ System for Male Infertility

Feb 09, 2016, 08:05 ET from Aytu BioScience, Inc.

ENGLEWOOD, Colo., Feb. 9, 2016 /PRNewswire/ -- Aytu BioScience, Inc. (OTCQX: AYTU), a commercial-stage specialty healthcare company focused on commercializing treatments for urological conditions, today announced the first commercial sales of its MiOXSYS™ System in Europe and the Middle East.  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 men. In January, MiOXSYS obtained CE Marking in Europe and other markets.

Josh Disbrow, Chief Executive Officer of Aytu, stated, "Within just weeks of receiving CE Marking, MiOXSYS has begun contributing to Aytu's portfolio of commercial products focused on the urology market. MiOXSYS is already showing itself to be a valuable product for our urology customers given the widespread need for improved diagnosis in the field of male infertility.  We look forward to additional sales in these regions as clinicians integrate MiOXSYS into their routine assessments of infertility status and monitoring of treatment effects. As we seek Food and Drug Administration (FDA) clearance in the United States, commercial use in foreign markets will contribute not only to Aytu's growing revenues, but to clinical understanding of the role of MiOXSYS in the diagnostic and treatment paradigms of male infertility. Given the early market interest following our CE Marking, we expect to begin building a distribution network for MiOXSYS in Europe, the Middle East and other key markets around the world."

A significant proportion of male infertility remains unexplained in part because of the lack of standardized, clinically feasible tests available to clinicians to assess oxidative stress, which is a well established contributor to idiopathic male infertility.  This lack of standardization has resulted in poor implementation of oxidative stress testing in semen analysis.  Aytu is currently working with major research institutions around the world to gain substantial, robust clinical experience using MiOXSYS to fulfill the unmet medical need in male infertility testing.

About Aytu BioScience, Inc.
Aytu BioScience is a commercial-stage specialty healthcare company focused on global commercialization of novel products in the field of urology. Aytu's current portfolio of commercial and late-stage urology products addresses prostate cancer, urinary tract infections, male infertility and male sexual dysfunction, and the company plans to expand into other urological indications for which there are significant medical needs. The company currently markets ProstaScint® (capromab pendetide), the only radio-labeled monoclonal antibody that targets prostate specific membrane antigen (PSMA), a protein highly expressed by prostate cancer cells. ProstaScint is FDA-approved as an imaging agent for use in both newly diagnosed, high-risk prostate cancer patients and patients with recurrent prostate cancer. Aytu also markets Primsol® (trimethoprim hydrochloride) – the only FDA-approved trimethoprim-only oral solution for urinary tract infections. Additionally, Aytu markets the CE Marked MiOXSYS™ System outside the US and is conducting US-based clinical trials, following which the company expects to receive 510k de novo medical device clearance.  The MiOXSYS System is a novel, rapid semen analysis system with the potential to become a standard of care in the diagnosis and management of male infertility.  MiOXSYS is the only rapid test for assessing oxidative stress in semen and seminal plasma, a leading contributor of idiopathic male infertility. Aytu's strategy is to continue building its portfolio of revenue-generating urology products and late-stage development assets, leveraging its commercial team and expertise to further build those brands within well-established markets.

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Forward Looking Statement
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SOURCE Aytu BioScience, Inc.