- Multi-Center, Global Study Demonstrates that MiOXSYS Provides an Accurate Measure of Seminal Oxidative Stress that can be Standardized Globally Within Clinical Andrology and IVF Laboratories
- Presentations Made by Leading Andrologists and Infertility Experts, on a Growing Body of Clinical and Scientific Evidence, Support the Expanding use of the MiOXSYS Platform in Clinical Practice Around the World

ENGLEWOOD, CO / ACCESSWIRE / July 10, 2018 / Aytu BioScience, Inc. (NASDAQ: AYTU), a specialty pharmaceutical company focused on global commercialization of novel products addressing significant medical needs, today announced that it has presented new clinical findings that further validate and expand the utility of its MiOXSYS® System as an advanced tool for assessing oxidative stress in human semen, which is considered a major cause of male infertility.

In total, seven presentations were made on the MiOXSYS System and the system's oxidation-reduction potential (ORP) diagnostic output by collaborators from five prominent andrology and infertility centers. These presentations were made at the 34th Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE), held in Barcelona, Spain from July 1-4, 2018.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, Inc., stated, "These seven presentations, together with the recent publication of ESHRE's Recurrent Pregnancy Loss and Multiple Miscarriage guidelines that identifies oxidative stress as a key factor in male infertility, further contribute to the broadening awareness of the utility of our MiOXSYS System. The recent findings highlight how important it is to accurately identify the underlying cause of male infertility, in part, through the assessment of DNA damage and direct measurement of seminal oxidative stress. MiOXSYS, a CE Marked diagnostic tool specifically measuring oxidative stress in semen, represents a rapid, accurate, in-office option to measure oxidative stress and help develop strategies to improve semen quality and male fertility."

Mr. Disbrow continued, "Studies, such as the large multi-center study presented at this year's ESHRE conference, demonstrate the robustness of our MiOXSYS System as a stable and accurate measure of oxidative stress that can be standardized globally within clinical andrology and IVF laboratories. Prior to the introduction of the MiOXSYS System, there were limited standardized and accurate options available to assess seminal oxidative stress. We are, therefore, pleased to continue to build the body of clinical and scientific evidence to support the expanding use of the MiOXSYS platform in clinical practice around the world."

The seven presentations were made by leading andrologists and infertility experts from a broad base of academic research institutions and infertility clinics, including the Cleveland Clinic, University of Kent in Canterbury, United Kingdom, CreATe Fertility Centre in Toronto, Canada, European Hospital in Rome, Italy, and Hamad Medical Corporation in Doha, Qatar.

The titles and presenters for each presentation are highlighted as follows:

Title: A Multicenter Study to Evaluate Oxidative Stress by Oxidation-Reduction Potential, a Reliable and Reproducible Method
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, Cleveland, Ohio
Conclusion: ORP levels can serve as an adjunct to routine semen analysis.
ORP remains stable even with measurable differences in sperm parameters, and it therefore can be used as a supplementary test to semen analysis to confirm oxidative stress and poor semen quality. Abnormal ORP levels may be helpful in identifying the altered functional status of the sperm in patients with poor semen quality and thereby directing those men to appropriate therapeutic management.

Title: Evaluating the Predictability of Oxidation-Reduction Potential in Male
Factor Infertility in Conjunction with Semen Analysis: A Multicenter Study
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, Cleveland, Ohio
Conclusion: ORP improved the overall predictability of determining semen quality when used in conjunction with semen analysis: performance characteristics: Sens: 97.1%, Spec: 43.7%, PPV: 94.2%, NPV: 61.7%.

Title: Validation of a Test Measuring ORP to Determine Oxidative Stress in Human Semen
Presenter: Sheryl T. Homa, Ph.D., Honorary Lecturer Department of BioSciences, University of Kent, Canterbury, United Kingdom
Conclusion: This simple to use, cost effective assay could be implemented in conjunction with semen analysis providing a welcomed addition to routine diagnostic testing for male infertility. It may be particularly relevant to men with unexplained infertility, whose partners experience a delay in conception, multiple assisted conception failures or miscarriages.

Title: Predictive Value of Static Oxidation-Reduction Potential in Detecting
High Levels of Sperm DNA Fragmentation in Infertile Men
Presenter: A. Lee BSc. CReATe Fertility Centre, Toronto, Ontario, Canada
Conclusion: Requiring as little as 5 minutes to complete and a drop (30μL) of semen, the MiOXSYS System provides a rapid, cost effective measure of global oxidative stress easily integrated into clinical workflows. It can be used to specifically identify patients with oxidative stress induced DNA damage for anti-oxidant therapy.

Title: Diagnostic Evaluation of Static Oxidation-Reduction Potential with MiOXSYS System (Male Infertility Oxidative System) in Normospermic versus Teratozoospermic Patients: A Retrospective Study
Presenter: F. Scarselli, European Hospital, Reproductive Medicine, Rome, Italy
Conclusion: Currently available assays for OS measure only discrete quantity of oxidants (ROS by chemiluminescence assay), antioxidants (total antioxidant capacity [TAC] assay) or Malondialdehyde (MDA assay) and are tedious, time consuming and expensive. MiOXSYS System is innovative in measuring ORP level in semen for its easiness and readiness.

Title: ORP is Correlated to Spermatogenic Testicular Function in Infertile Men
Presenter: A. Majzoub, Urology Department - Hamad Medical Corporation, Doha, Qatar
Conclusion: ORP can be used as a marker of spermatogenesis in infertile men. Further studies should be carried out to demonstrate the effect of treating OS on spermatogenesis. Since varicocele patients show seminal oxidative stress, smaller testes and higher FSH values, ORP could possibly be used as adjunct indicator of varicocele.

Title: Effect of Varicocelectomy on ORP in Varicocele Associated Male Infertility
Presenter: H. Elbardisi, Urology Department - Hamad Medical Corporation, Doha, Qatar
Conclusion: ORP as a measure of oxidative stress in infertile patients with varicocele can be used as a prognostic factor for counselling patients before varicocelectomy.

Selection of the abstracts for publication in the press program 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 addressing significant medical needs. The Company currently markets Natesto®, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"). 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, Australian TGA approved product, and Aytu is planning U.S.-based clinical trials in pursuit of 510k medical device clearance by the FDA. Aytu recently acquired exclusive U.S. rights to ZolpiMist™, an FDA-approved, commercial-stage prescription sleep aid indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large, growing markets. For more information visit aytubio.com.

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SOURCE: Aytu BioScience, Inc.