Englewood, CO – April 5, 2016 – Aytu BioScience, Inc. (OTCQX: AYTU), a commercial-stage specialty healthcare company focused on urological and related conditions, observed encouraging data from two prospective studies of its MiOXSYS™ System that demonstrated its clinical utility as a tool for measuring oxidation-reduction potential (ORP) to assess the degree of oxidative stress levels in human semen. Such oxidative stress is broadly implicated as a major cause of male infertility. The results were presented on April 3rd and 4th at the 41st American Society of Andrology (ASA) annual meeting in New Orleans, Louisiana.

The studies’ principal investigator, Prof. Suresh C. Sikka, Research Director of Urology and Andrology labs, Tulane University Health Sciences Center, and his group presented the following:

Title 1: “Semen oxidation-reduction potential (ORP) is related to abnormal semen parameters in male factor infertility.”
Presented by Dr. Jaideep S. Toor
Date: April 3rd, 2016
Location: Astor Crowne Plaza Hotel, New Orleans, LA
Session: Infertility

Title 2: “Measurement of oxidation-reduction potential (ORP) as a newer tool indicative of oxidative stress in infertile men with leukocytospermia.”
Presented by Dr. Suresh C. Sikka
Date: April 4th, 2016
Location: Astor Crowne Plaza Hotel, New Orleans, LA
Session: Infertility

The first study measured sORP in the semen samples of infertile men that correlated well with the sperm concentration, motility, and morphology. A significantly high sORP/cORP ratio as assessed by the MiOXSYS System in infertile patients with low sperm concentration and motility, suggests the role of increased oxidative stress. These findings suggest that ORP, as measured by MiOXSYS, can be used effectively in the screening of infertile men with oxidative stress. The results are currently being validated in a larger cohort of infertile men.

The second study further suggests that sORP is an easy to determine one-step indicator of increased oxidative stress in semen samples of infertile men especially with leukocytospermia. The ORP parameter, as measured by MiOXSYS, could potentially serve as an important additional indicator in the workup of male factor infertility. It will be important to carry out larger standardized studies, hopefully in a multicenter format to establish such role of MiOXSYS evaluation. Taken with the MiOXSYS System’s ability to produce real-time results, it is easy to employ this system for diagnostic use in routine clinical practice.

Josh Disbrow, Chief Executive Officer of Aytu, stated, “Major academic systems around the world have been investigating the clinical utility of the MiOXSYS System as a diagnostic tool for helping to guide the treatment of male infertility caused by oxidative stress. This work with our collaborators will continue as we prepare to initiate FDA-directed studies to validate MiOXSYS and expand access to this potentially groundbreaking reproductive health test to the U.S.”

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 U.S. and is conducting U.S.-based clinical trials, following which the company plans to seek 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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