Englewood, CO – July 13, 2017 – Aytu BioScience, Inc. (OTCQX: AYTU), a specialty pharmaceutical company focused on global commercialization of novel products in the field of urology, today announced the signing of an exclusive distribution agreement for MiOXSYS® with GryNumber Health – a leading specialty healthcare company serving the fertility market throughout Central and Southeast Europe and Scandinavia.
Josh Disbrow, Chief Executive Officer of Aytu, commented, “We are very pleased to further expand our worldwide distribution network for MiOXSYS®. GryNumber Health is an ideal partner for Aytu given their footprint in more than 20 countries in Europe and their specific focus on marketing solutions in the fertility field. Our expanding network of distributors for MiOXSYS® continues to demonstrate the significant interest and need for an innovative diagnostic platform that has the potential to benefit the millions of men worldwide dealing with infertility.”
Valdemaras Rodzko, Chief Executive Officer of GryNumber Health, stated, “GryNumber Health is establishing itself as a leader in the diagnosis and treatment of male and female infertility throughout Europe and we are very enthusiastic about bringing MiOXSYS® to our many customers. The MiOXSYS® platform is an exciting advancement in male infertility, and we are optimistic about its significant potential in Europe and worldwide. We look forward to a successful partnership with Aytu and helping to further establish MiOXSYS® as an important diagnostic that will be beneficial to the millions of European men challenged by infertility.”
Aytu expects to continue to expand its ex-U.S. distribution channel in line with ramping commercial sales in territories where MiOXSYS® is approved while the company pursues regulatory clearance in the U.S. through the FDA’s 510(k) pathway.
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 that 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 Aytu BioScience visit www.aytubio.com.
About GryNumber Health
GryNumber Health is a fast growing healthcare company specializing in promotion and distribution of pharmaceuticals, medical devices and food supplements for the treatment and diagnostics of both male and female infertility. Headquartered in Vienna, Austria and with subsidiaries across Europe, GryNumber Health has established a strong presence in more than 20 countries throughout the Central and South East Europe and Scandinavia. The company’s synergy within the portfolio of innovative fertility products supports health care professionals to help subfertile patients to conceive.
For more information: www.grynumberhealth.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: our anticipated future cash position and our need for additional capital in the near term, the risk of integrating Nuelle into our operations and realizing benefits from the acquisition, risks relating to gaining and increasing 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, 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, as amended by our Form 10-Q for the quarter ended March 31, 2017 and in the other reports and documents we file with the Securities and Exchange Commission from time to time.
Amato and Partners, LLC
Investor Relations Counsel