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Aytu BioScience Announces Availability of the MiOXSYS(R) Male Infertility Test in South Africa

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Androcryos, South Africa’s Largest Sperm Bank, First Laboratory in Africa to Offer MiOXSYS Test

ENGLEWOOD, CO / ACCESSWIRE / September 10, 2019 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on global commercialization of novel products addressing significant medical needs, today announced that MiOXSYS®, the company’s first-in-class seminal oxidative stress test for the assessment of male infertility, is now available in South Africa and is offered through Androcryos, the largest sperm bank on the African continent.

MiOXSYS, the Male Infertility Oxidative System, is CE marked and cleared by Health Canada, Australia's TGA, and Mexico's COFEPRIS. MiOXSYS is the first cleared advanced in vitro diagnostic test that assesses seminal oxidative stress, a major cause of male infertility.

Androcryos, established in 1984, is an andrology laboratory and cryogenic sperm bank and offers the most comprehensive testing of any sperm bank in the African continent.

According to published reports, an estimated 12% of South Africa’s twenty-nine million men have azoospermia (absence of motile sperm), and it is estimated that 34.2% of South African men are sub-fertile.

Petrus Loubser, General Manager at Androcryos, commented, “Our laboratory has introduced the MiOXSYS System as an additional means of further evaluating semen quality in our sperm donor population as well as all other men with possible male factor infertility. Given the known pathological consequences of oxidative stress on sperm, it further highlights the importance of measuring oxidative stress for sperm function. The combination of the MiOXSYS System with our already expansive donor screening process should give patients greater confidence and transparency of our commitment to quality.”

Mr. Loubser continued, “The MiOXSYS System is also an excellent tool to measure antioxidant treatment requirements and efficacy and thus allows for a targeted rather than a blanket treatment approach. Patients can currently be tested at Androcryos facilities in Johannesburg (Gauteng Province), Natal Fertility Clinic in Umhlanga (KwaZulu-Natal Province), and Enigma Andrology Laboratory in Bloemfontein (Free State Province).”

Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated, “We are excited about the clinical acceptance of the MiOXSYS System by Androcryos and the fact that MiOXSYS is now available in South Africa for the first time. We believe this acceptance by this leading andrology laboratory further demonstrates the diverse clinical use of MiOXSYS and underscores the fact that an increasing number of laboratories around the world are testing for seminal oxidative stress.”

Mr. Disbrow continued, “Androcryos has uncovered a unique clinical use for MiOXSYS as an indicator of semen quality in sperm donors, so this represents a novel approach and further expands the clinical utility of MiOXSYS. We look forward to a productive partnership with Androcryos as they have become the first laboratory on the African continent to offer the MiOXSYS System.”

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets Natesto®, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"). Aytu also has exclusive U.S. and Canadian rights to ZolpiMist™, an FDA-approved, commercial-stage prescription sleep aid indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Aytu recently acquired exclusive U.S. commercial rights to Tuzistra® XR, the only FDA-approved 12-hour codeine-based antitussive syrup. Tuzistra XR is a prescription antitussive consisting of codeine polistirex and chlorpheniramine polistirex in an extended-release oral suspension. 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 of the U.S. where it is a CE Marked, Health Canada cleared, Australian TGA approved, Mexican COFEPRAS approved product. Aytu is planning U.S.-based clinical trials in pursuit of 510k de novo 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 large therapeutic markets. For more information visit aytubio.com.

Forward-Looking Statements

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, 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 our products, obtaining or maintaining 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 collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company'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:

James Carbonara
Hayden IR

SOURCE: Aytu BioScience, Inc.

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