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Aytu BioScience Announces Presentation of Novel Clinical Findings for its Proprietary MiOXSYS(R) Male Infertility Test at Global Reproductive Medicine Scientific Conference

11 Abstracts Featuring MiOXSYS have been Selected for Presentation at the 35th Annual Meeting of the European Society of Human Reproduction and Embryology

ENGLEWOOD, CO / ACCESSWIRE / June 18, 2019 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced that multiple presentations highlighting the company's MiOXSYS® male infertility diagnostic system will be presented at the 35th Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE). ESHRE will be held in Vienna, Austria from June 23-26, 2019, and members of the Aytu BioScience management team will be in attendance.

In total, 11 abstracts featuring MiOXSYS, and the system's diagnostic output oxidation-reduction potential (ORP), have been accepted for presentation at ESHRE and will be presented by leading researchers in andrology, urology, and reproductive medicine from around the world.

The following two showcase presentations will be the first to report on new fertilization data that further expands the clinical utility of the company's MiOXSYS System as an advanced tool aiding in the diagnosis of male infertility. The presentations will take place in the Haydn Room of the Messe Wien Exhibition & Congress Center on June 24, 2019.

Title: "Prediction of successful ICSI cycles by oxidation-reduction potential (ORP) and sperm DNA fragmentation (SDF) analysis. A prospective study"
Presenter: Aqeel Morris, BSc, Department of Medical Biosciences
Institution: University of Western Cape, Bellville, South Africa
Presentation Time: 10:15 am CET

Title: "Relationship between oxidative stress in semen and the fertilizing capacity of the sperm - Evidence from the conventional IVF model in couples with unexplained infertility"
Presenter: Hassan Sallam, MD, PhD, Professor in Obstetrics & Gynecology
Head of Alexandria Fertility & IVF Center
Institution: University of Alexandria, Alexandria, Egypt
Presentation Time: 5:00 pm CET

Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated, "With the recent publication of ESHRE's Recurrent Pregnancy Loss and Multiple Miscarriage guidelines, there is broadening awareness of the importance of accurately identifying the cause of male infertility, in part, through the assessment of DNA damage and direct measurement of seminal oxidative stress. MiOXSYS, a CE marked diagnostic tool specifically measuring oxidative stress in semen, provides clinicians with a simple in-office test to quickly and accurately assess oxidative stress and help develop strategies to improve semen quality and male fertility."

Mr. Disbrow continued, "Prior to the introduction of the MiOXSYS System, there were limited standardized, and accurate options available to assess seminal oxidative stress, and none that could be practically used in an office-based clinical setting. We are, therefore, pleased to continue to advance the body of clinical and scientific evidence to support the expanding use of the MiOXSYS platform in office-based settings to enable broader clinical use around the world."

Additional ESHRE-selected presentations featuring MiOXSYS are being made by leading andrologists, urologists, and reproductive medicine experts from a broad base of research institutions and infertility clinics around the world, including:

  • Cleveland Clinic, Cleveland, OH
  • University of Antwerp, Antwerp, Belgium
  • Medical University of Lublin, Lublin, Poland
  • Centre Fertillia, Tunis, Tunisia
  • Hamad Medical Corporation, Doha, Qatar
  • University of Osaka, Osaka, Japan

The MiOXSYS System is currently in use in over thirty countries around the world and is CE Marked and cleared by Health Canada, the Australian Therapeutic Goods Administration (TGA), and Mexico's COFEPRAS.

Selection of the abstracts for publication in this press release does not imply endorsement of the MiOXSYS System by ESHRE.

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, and 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 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 revenue growth, 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 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:

James Carbonara
Hayden IR
(646)-755-7412

SOURCE: Aytu BioScience, Inc.



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