ENGLEWOOD, Colo., Nov. 7, 2017 /PRNewswire/ -- Aytu
BioScience, Inc. (NASDAQ: AYTU), a specialty life sciences company
focused on global commercialization of novel products in the field
of urology, today 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.
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 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
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: risks relating to
gaining market acceptance of any 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, our anticipated future
cash position 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 and in the other reports and documents we file
with the Securities and Exchange Commission from time to time.
Contact for Investors:
Amato and Partners, LLC
Investor Relations Counsel
admin@amatoandpartners.com
View original content with
multimedia:http://www.prnewswire.com/news-releases/aytu-bioscience-receives-market-approval-from-the-australian-therapeutic-goods-administration-for-the-mioxsys-system-for-male-infertility-300550640.html
SOURCE Aytu BioScience, Inc.