Aytu BioScience Receives Market Registration for the MiOXSYS® System for Male Infertility in Mexico
Aytu BioScience Receives Market Registration for the MiOXSYS® System for Male Infertility in Mexico
ENGLEWOOD, Colo., March 7, 2018 /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 it has received registration in Mexico for the MiOXSYS System, from the Secretary of Health at Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS). The MiOXSYS System will be distributed exclusively through IMP Medica, a distributor of medical products to urologists, andrologists, and fertility centers throughout Mexico and in key markets in Latin America.
Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "Regulatory licenses and registrations are critical to our efforts of effectively penetrating these new markets. MiOXSYS continues to gain traction with its international commercial expansion as regulatory bodies, like Mexico's COFEPRIS, approve the product for clinical use in the assessment of male infertility."
Mexico is one of the top ten largest countries in the world, with a population of over 127 million. Approximately one in six couples suffer from infertility, and almost half of these cases can be attributed to male factor infertility. Male infertility assessment remains a significant area of clinical need around the world.
Mr. Disbrow added, "We recently appointed IMP Medica, headquartered in Mexico City, Mexico, as exclusive distributor of the MiOXSYS System in Mexico. We are pleased to now be able to offer MiOXSYS to clinicians and laboratories throughout Mexico who seek to better identify and treat men with suspected infertility and for which oxidative stress may be implicated."
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, Australian TGA approved 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 www.aytubio.com. Aytu also now wholly-owns its 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 product for women that is scientifically proven to enhance physical arousal and sexual desire. Fiera is a consumer product and is not intended to treat, mitigate, or cure any disease or medical condition. For more information about the Fiera personal care product visit fiera.com.
Cautionary Statement Regarding Forward Looking Statements
Statements contained herein that are not based upon current or historical fact are forward-looking in nature and constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements reflect the Company's expectations about its future operating results, performance and opportunities that involve substantial risks and uncertainties. These statements include but are not limited to statements regarding the intended terms of the offering, closing of the offering and use of any proceeds from the offering. When used herein, the words "anticipate," "believe," "estimate," "upcoming," "plan," "target", "intend" and "expect" and similar expressions, as they relate to Aytu BioScience, Inc., its subsidiaries, or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to the Company and are subject to a number of risks, uncertainties, and other factors that could cause the Company's actual results, performance, prospects, and opportunities to differ materially from those expressed in, or implied by, these forward-looking statements.
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SOURCE Aytu BioScience, Inc.
