Aytu BioScience Presents Clinical Findings for its MiOXSYS™ System at 32nd Annual Meeting of the European Society of Human Reproduction and Embryology

ENGLEWOOD, Colo., July 7, 2016 /PRNewswire/ -- Aytu BioScience, Inc. (OTCQX: AYTU), a specialty pharmaceutical company focused on global commercialization of novel products in the field of urology, today announced that it presented three posters demonstrating the potential of MiOXSYS™, Aytu's rapid in vitro diagnostic system for the quantitative measurement of static oxidation-reduction potential (sORP) in human semen, to be used as an aid in the diagnosis of infertility in males.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, Inc., stated, "The medical and scientific community have long understood that oxidative stress negatively impacts male fertility. At the same time, there has not been an easily accesssible, rapid, in-office option to measure oxidative strees in semen. Aytu has been committed to conducting research to potentially validate the ability of the MiOXSYS system to fill this gap."

The posters are as follows:

Title: Seminal fluid static oxidation-reduction potential is lower in seminal fluid that meets all WHO criteria for fertile men
Poster Number: P-012
Session: Andrology
Presenter: AlSaid, Urology Department – HMC, Doha, Qatar;
Conclusion: Semen that fail one or more parameters for normal semen had higher levels of oxidative stress. Abnormal morphology contributes to increasing sORP values.  Semen with an sORP value greater than 1.635mv/10⁶ sperm/mL had a 98.6% chance of being abnormal on one or more of the semen parameters. This represents an initial clinical cut-off value  for interpreting the results of  the MiOXSYS System, an adjunct measure to routine semen analyses.

Title: Oxidation-reduction potential: A new predictor for sperm morphology in infertile men
Poster Number: P-013
Session: Andrology
Presenter: AlSaid, Urology Department – HMC, Doha, Qatar;
Conclusion: Semen with abnormal parameters have higher levels of oxidative stress.  By measuring sORP, a cut-off value of 3.29mV/10⁶ sperm/mL was able to reliably predict abnormal morphology. This study suggests that measuring sORP might provide users with an independent measure for confirming sperm morphology.  

Title: Oxidation-reduction Potential (ORP) of Spermatozoa Selected for Intracytoplasmic Sperm Injection (ICSI) After Exposure to Polyvinylpyrrolidone (PVP) and Hyaluronic Acid (HA) 
Poster Number: P-019
Session: Andrology
Presenter: Ashok Agarwal, Ph.D., Director of the Andrology Center and Director of the American Center for Reproductive Medicine under the Glickman Urological & Kidney Institute, Cleveland Clinic
Conclusion: Lower levels of sORP in PVP-treated group than in the HA-treated group and the control group are novel findings and suggest that PVP might alleviate sperm oxidative stress as it contains a synthetic serum replacement that acts as a chelating agent. Our results support the continued clinical use of PVP for selection and manipulation in ICSI processes.

Selection of the abstracts for publication in the press programme does not imply endorsement of the MiOXSYS System by ESHRE^®.

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 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.

For Investors & Media:
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D.: [email protected]; (212) 375-2664
Janine McCargo: [email protected]; (646) 604-5150

Forward Looking Statement
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SOURCE Aytu BioScience