Englewood, CO – May 15, 2017 – 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 two posters demonstrating new clinical findings that further validate and expand the potential utility of its MiOXSYS System as an advanced tool for assessing oxidative stress in human semen, which is broadly implicated as a major cause of male infertility.
Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated, “These latest research findings add robustness to our MiOXSYS System, which we’ve already demonstrated to be a uniquely dynamic tool for assessing oxidative stress levels in semen as it relates to male infertility. MiOXSYS represents an easily accessible, rapid, in-office option to measure oxidative stress in semen. Identifying high levels of oxidative stress can help rule in the cause of poor semen quality and lead to strategies associated with the improvement of semen quality and male fertility. Aytu has been committed to conducting research to potentially validate the ability of the MiOXSYS system to fill this clinical gap.”
The posters are as follows:
Title: Role of Oxidation-Reduction Potential in Varicocele Associated Infertility
Poster Number: MP07-17
Session: Basic Research and Pathophysiology
Presenter: Mohamed Arafa, Urology Department – HMC, Doha, Qatar;
Conclusion: ORP plays a role in the pathophysiology of varicocele associated infertility. Treatment targeting on ORP reduction may potentially improve semen quality in these patients.
Title: Involvement of Oxidation-Reduction Potential in the Pathophysiology of Male Infertility in Patients with Varicocele.
Poster Number: MP07-19
Session: Basic Research and Pathophysiology
Presenter: Ashok Agarwal, Ph.D., Director of the Andrology Center and American Center for Reproductive Medicine under the Glickman Urological & Kidney Institute, Cleveland Clinic
Conclusion: Our result showed that both sperm parameters and ORP values distinguished infertile patients with varicocele from normal healthy men. The elevated ORP levels further support the role of OS as an underlying mechanism of infertility in varicocele patients.
Selection of the abstracts for publication in the press program does not imply endorsement of the MiOXSYS System by AUA.
About Aytu BioScience, Inc.
Aytu BioScience is a commercial-stage specialty life sciences company focused on global commercialization of novel products in the field of urology, with a focus on products addressing vitality, sexual wellness, and reproductive health. The company currently markets two prescription products in the U.S.: Natesto®, the first and only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or “Low T”) and ProstaScint® (capromab pendetide), the only FDA-approved imaging agent specific to prostate specific membrane antigen (PSMA) for prostate cancer detection and staging. 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 planning U.S.-based clinical trials in pursuit of 510k medical device clearance by the FDA. 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 growing markets. For more information visit aytubio.com. Aytu also now owns wholly-owned subsidiary Nuelle, Inc., a personal health and wellness company focused on women’s sexual wellbeing and intimacy that markets Fiera, a personal care device for women that is scientifically proven to enhance physical arousal and sexual desire. Fiera is a consumer device and is not intended to treat, mitigate, or cure any disease or medical condition. For more information about Aytu BioScience visit aytubio.com. For more information about the Fiera personal care device visit fiera.com.
Forward Looking Statement
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, including statements regarding our anticipated future clinical and regulatory events, future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. Forward looking statements are generally written in the future tense and/or are preceded by words such as “may,” “will,” “should,” “forecast,” “could,” “expect,” “suggest,” “believe,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: our anticipated future cash position and our need for additional capital in the near term, the risk of integrating Nuelle into our operations and realizing benefits from the acquisition, risks relating to gaining and increasing market acceptance of our products, obtaining reimbursement by third-party payors, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, and future events under our current and potential future collaborations. We also refer you to the risks described in “Risk Factors” in Part I, Item 1A of Aytu BioScience, Inc.’s Annual Report on Form 10-K, as amended by our Form 10-Q for the quarter ended March 31, 2017 and in the other reports and documents we file with the Securities and Exchange Commission from time to time.
Amato and Partners, LLC
Investor Relations Counsel