Aytu BioScience Receives Market Approval for the MiOXSYS System for Male Infertility

Aytu BioScience, Inc. recently announced that the Australian Government Department of Health and Therapeutic Goods Administration (TGA) has approved the MiOXSYS System for inclusion on the Australian Register of Therapeutic Goods. MiOXSYS has been approved by the TGA as an aid in the diagnostic assessment of semen quality for patients undergoing male infertility evaluation.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented “MiOXSYS continues to gain traction with its international commercial expansion as regulatory bodies, like Australia’s TGA, approve the product for clinical use in the assessment of male infertility. In Australia, approximately one in six couples suffer from infertility, and almost half of these cases can be attributed to male factor infertility. Therefore, male infertility assessment remains a significant area of clinical need. We are pleased to now be able to offer MiOXSYS to clinicians and laboratories throughout Australia who seek to better identify and treat men with suspected infertility and for which oxidative stress may be implicated.”

With Australian TGA approval, the Company has engaged in Australian market development activities and is in early discussions with distribution partners. The Company expects to announce a distribution partner and launch MiOXSYS for clinical use in the coming quarters.

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 US, where it is a CE Marked, Health Canada cleared product, and Aytu is planning US-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 Aytu Women’s Health (formerly Nuelle, Inc.), a personal health and wellness company focused on women’s sexual wellbeing and intimacy. Aytu Women’s Health 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 the Fiera personal care device, visit www.fiera.com.