Full Press Release Details
Announces Issuance of First U.S. Patent Covering MiOXSYS for Male Infertility; Company Progresses Toward U.S. Regulatory
Clearance and Commercialization
10,088,466 is Company's First United States Patent Covering MiOXSYS for Male Inferility Assessment
ENGLEWOOD, CO / ACCESSWIRE / October
11, 2018 / Aytu BioScience, Inc. (NASDAQ: AYTU), a specialty pharmaceutical company focused on global commercialization of
novel products addressing significant medical needs, today announced the issuance of a U.S. patent covering the company's
proprietary MiOXSYS diagnostic platform for male infertility. This is the first patent specifically covering fertility measurement
methods with the MiOXSYS System and is the 15th U.S. patent overall covering the system's core oxidation-reduction potential
(ORP) technology and its uses. The newly issued patent expires November 24, 2035.
U.S. Patent 10,088,466, entitled Determination
of fertility potential from the oxidation-reduction potential of a biological sample, covers a method of determining characteristics
of a semen sample via the measurement of static oxidation-reduction potential (sORP) of the semen sample from a subject in a specified
ratio range of sORP to sperm concentration in a liquified semen sample. sORP, the diagnostic output of the MiOXSYS System and
a direct measure of oxidative stress, serves as an aid in the diagnosis of male infertility in directly measuring oxidative stress
in semen, the cause of DNA damage and a leading cause of male infertility.
Josh Disbrow, Chief Executive Officer
of Aytu BioScience commented, "This patent issuance for the company's diagnostic platform is an important step in
moving closer to U.S. commercialization and providing another approved, commercial-stage product to our established U.S. commercial
infrastructure. This validation of our proprietaty oxidation-reduction potential technology helps to further unlock the potential
of MiOXSYS and position it as a complement to Natesto as the second urology-centric product in our portfolio. As we advance
MiOXSYS toward a 510k de novo clearance in the U.S., we continue to demonstrate very good progress outside the U.S. as MiOXSYS
The global male infertility market is
expected to reach $4.7 billion by 2025, and increasing infertility in men and advancements in diagnostic tests are expected to
be key factors in driving this market growth.
MiOXSYS is currently commercialized
through a distribution network outside the U.S. and has been sold into 29 countries to date. The company is conducting clinical
studies with U.S. collaborators in order to establish a U.S. specific regulatory clearance pathway with the FDA.
MiOXSYS is CE Marked and is approved
by Health Canada, the Australian TGA, and Mexico's COFEPRAS. The clinical utility and scientific validation of sORP have
been demonstrated in 10 studies published to date.
Aytu BioScience, Inc.
BioScience is a commercial-stage specialty pharmaceutical company focused on global commercialization of novel products addressing
significant medical needs. The company currently markets Natesto , the only FDA-approved nasal formulation of testosterone
for men with hypogonadism (low testosterone, or "Low T"). 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 recently acquired 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'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, growing markets. For more information visit aytubio.com.
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