Aytu BioScience Further Demonstrates Clinical Utility For MiOXSYS System As An Aid In The Diagnosis Of Male Infertility
ENGLEWOOD, Colo., Nov. 1, 2016 /PRNewswire/ -- Aytu BioScience, Inc. (OTCQX: AYTU), a specialty pharmaceutical company focused on global commercialization of novel products in the field of urology, today announced that it presented five posters demonstrating the clinical potential of MiOXSYS, Aytu's rapid in vitro diagnostic system for the qualitative measurement of static oxidation-reduction potential (sORP) in human semen, to be used as an aid in the diagnosis of infertility in men.
Josh Disbrow, Chief Executive Officer of Aytu BioScience, Inc., stated, "This represents the first demonstration of MiOXSYS's clinical application in three leading clinical centers and further validates the significance of oxidative stress as a diagnostic marker for male infertility. MiOXSYS is the only easily accessible, rapid, in-office option to measure oxidative stress in semen. Identifying high levels of oxidative stress can help determine the cause of poor semen quality and lead to strategies designed to improve semen quality and male fertility. Aytu is committed to conducting research to validate the potential for the MiOXSYS System to fill this clinical gap. Aytu is in the process of initiating clinical studies to support potential FDA clearance of MiOXSYS."
The posters are as follows:
Title: OXIDATION-REDUCTION POTENTIAL - A NOVEL TEST FOR EVALUATING MALE INFERTILITY
Poster: P-503
Session: Male Reproduction and Urology - Clinical
Presenter: Ashok Agarwal, Ph.D., Director of the Andrology Center and Director of the American Center for Reproductive Medicine under the Glickman Urological & Kidney Institute, Cleveland Clinic
Results: Semen samples were obtained from 51 normal healthy controls and 106 infertile men. The mean ORP (mV/106 sperm/mL) in the semen of the infertile patients was 6.22±1.10 mV/106 sperm/mL whereas that of the control group was 1.59±0.29 mV/106 sperm/mL (p = 0.004).
Conclusion: ORP can distinguish between male factor infertility patients and healthy normal men, making it an accurate method for ruling in oxidative stress in male factor infertility patients
Title: OXIDATION-REDUCTION POTENTIAL: A NOVEL MARKER OF VARICOCELE PATHOPHYSIOLOGY
Poster: P-499
Session: Male Reproduction and Urology Clinical
Presenter: Ashok Agarwal, Ph.D., Director of the Andrology Center and Director of the American Center for Reproductive Medicine under the Glickman Urological & Kidney Institute, Cleveland Clinic
Results: Thirty-eight patients with clinical varicocele presenting with primary infertility were subdivided into 3 groups according to clinical grade. Compared with controls, a direct relationship (p<0.05) was seen between high ORP levels and men with grade 3 varicocele.
Conclusion: ORP measurement may have potential benefit before and after varicocele surgery to assess surgical success
Title: EVALUATION OF INTRA- AND INTER-OBSERVER RELIABILITY OF THE ORP (OXIDATION-REDUCTION POTENTIAL) TEST FOR OXIDATIVE STRESS (OS) IN MALE FACTOR INFERTILITY
Poster: P-516
Session: Male Reproduction and Urology - Clinical
Presenter: Ashok Agarwal, Ph.D., Director of the Andrology Center and Director of the American Center for Reproductive Medicine under the Glickman Urological & Kidney Institute, Cleveland Clinic
Results: A total of 120 measurements of ORP (mV/106 sperm/mL) were taken by three experienced observers from ten semen samples measured in four replicates. The coefficient of variation across observers was 3.61%.
Conclusion: Intra-observer and inter-observer reliability experiments confirm the reproducibility of the MiOXSYS System for use in a clinical setting
Title: INFERTILE MEN HAVE A REDOX IMBALANCE THAT DISTINGUISHES THEM FROM FERTILE MEN
Poster: P-343
Session: Male Reproduction and Urology - Research
Presenter: Ahmet Ayez, Ph.D., Yildiz Technical University, Istanbul, Turkey
Results: Semen samples were obtained from 50 infertile and fertile patients. Semen analysis was done according to WHO 2010 and sORP was measured using the MiOXSYS System.
Conclusion: Infertile donors had higher sORP values then fertile. The odds of being infertile with a sORP value greater than 1.38 mV/sperm concentration were 9.76 times higher than if the sORP was lower. 63% of donors had abnormal morphology, including 38% of fertile and 97% of infertile.
Title: SEMINAL OXIDATION-REDUCTION POTENTIAL CAN DIFFERENTIATE FERTILE FROM INFERTILE MEN
Poster: P-340
Session: Male Reproduction and Urology - Research
Presenter:Mohamed Arafa, Ph.D. Urology Department-HMC, Doha, Qatar
Results: Semen samples were obtained from 365 infertile and 50 fertile patients. Semen analysis was done according to WHO 2010 and sORP was measured using the MiOXSYS System. Sperm count, total motility and progressive motility were significantly lower in the infertile group than the control groups (p<0.001). The measured sORP (mean ± SE) in infertile men was 24.06 ± 4.13 mV/106 sperm/mL, while that of fertile men was 1.15 ± 0.12 mv/106 sperm/mL (P<0.001).
Conclusion: sORP provides an objective and repeatable measure for identification of patients more likely to be infertile
About Aytu BioScience, Inc.
Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on global commercialization of novel products in the field of urology. The company currently markets three products: Natesto®, the first and only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), ProstaScint® (capromab pendetide), the only FDA-approved imaging agent specific to prostate specific membrane antigen (PSMA) for prostate cancer detection and staging, and Primsol® (trimethoprim hydrochloride), the only FDA-approved trimethoprim-only oral solution for urinary tract infections. 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 conducting 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 urology products, leveraging its focused commercial team and expertise to build leading brands within well-established markets. For more information visit aytubio.com.
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