Full Press Release Details
Aytu BioScience Awarded Health Canada
Approval for Its MiOXSYS System for Male Infertility
Englewood, CO - March 31, 2016 - Aytu BioScience,
Inc. (OTCQX: AYTU), a commercial-stage specialty healthcare company focused on global commercialization of novel products in
the field of urology, has obtained Health Canada Class II Medical Device approval for its MiOXSYS System. MiOXSYS is the
company's in vitro diagnostic platform for assessing the level of oxidative stress in semen as an aid in the diagnosis of infertility
The MiOXSYS System received CE Marking in the European Union
in January and has posted its first commercial sales in Europe and the Middle East. With Health Canada approval now in place, the
company will begin initial marketing of the product, while also looking for strategic opportunities to build partnerships with
prominent hospitals, academic centers, and early MiOXSYS users to develop the market in Canada.
Josh Disbrow, Chief Executive Officer of Aytu, stated, "Achievement
of this milestone reflects our focus on commercializing best-in-class urology products and marketing those products strategically.
As we pursue FDA clearance of MiOXSYS in the United States, we expect to benefit greatly from these early commercialization efforts
in key markets. In Europe and the Middle East, our urology customers are already beginning to see the value of MiOXSYS, and this
interest is being driven by the widespread need for improved diagnosis in the field of male infertility."
About Aytu BioScience, Inc.
Aytu BioScience is a commercial-stage specialty
healthcare company focused on global commercialization of novel products in the field of urology. Aytu's current
portfolio of commercial and late-stage urology products addresses prostate cancer, urinary tract infections, male infertility
and male sexual dysfunction, and the company plans to expand into other urological indications for which there are
significant medical needs. The company currently markets ProstaScint (capromab pendetide), the only radio-labeled
monoclonal antibody that targets prostate specific membrane antigen (PSMA), a protein highly expressed by prostate cancer
cells. ProstaScint is FDA-approved as an imaging agent for use in both newly diagnosed, high-risk prostate cancer patients
and patients with recurrent prostate cancer. Aytu also markets Primsol (trimethoprim hydrochloride) - the only
FDA-approved trimethoprim-only oral solution for urinary tract infections. Additionally, Aytu markets the CE Marked
MiOXSYS System outside the US and is conducting US-based clinical trials, following which the company expects to
receive 510k de novo medical device clearance. The MiOXSYS System is a novel, rapid semen analysis system with the potential
to become a standard of care in the diagnosis and management of male infertility. MiOXSYS is the only rapid test for
assessing oxidative stress in semen and seminal plasma, a leading contributor of idiopathic male infertility.
Aytu's strategy is to continue building its portfolio of revenue-generating urology products and late-stage development
assets, leveraging its commercial team and expertise to further build those brands within well-established markets.
For Investors & Media:
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D.: jdrumm@tiberend.com; (212) 375-2664
Janine McCargo: jmccargo@tiberend.com; (646) 604-5150
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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
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to gaining 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, 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.