Tuesday November 7, 2017 0 comments
ENGLEWOOD -- Aytu BioScience, Inc. (NASDAQ: AYTU), a specialty life sciences company focused on global commercialization of novel products in the field of urology, today announced 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.
"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,” said Josh Disbrow, Aytu CEO.
“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 said it has engaged in Australian market development activities and is in early discussions with distribution partners.
Aytu said it expects to announce a distribution partner and launch MiOXSYS for clinical use in the coming quarters.