New FDA-Cleared Urinary Tract Infection Test to be Sold Under the
SAN DIEGO–(BUSINESS WIRE)–Innovus Pharmaceuticals, Inc. (“Innovus Pharma” or the “Company”) (OTCQB
Venture Market: INNV), an emerging commercial-stage pharmaceutical
company that delivers safe, innovative and effective over-the-counter
medicine and consumer care products to improve men’s and women’s health
and respiratory diseases, today announced that it has entered into an
agreement with ACON Laboratories, Inc. (“ACON Labs”). ACON
Labs is a San Diego-based diagnostic product manufacturer who
will supply Innovus Pharma with its U.S. Food and Drug Administration’s
(“FDA”) cleared Urinary Tract Infection (“UTI”) test strips. Innovus
Pharma will offer the UTI test strips, which provide results in
2-minutes, to its customers who buy its UriVarx™ product. UriVarx™ is
clinically tested in patients with overactive bladder (“OAB”) and
urinary incontinence (“UI”). Innovus Pharma is expected to launch the
UTI strips under its UriVarx™ brand in Q1 2018.
According to WebMD, UTIs are the most common bacterial infections in the
United States. According to a study by the National Institutes of Health
in 2007 (NIH publication 075512) by Griebling et al., the prevalence of
UTI is found to be higher in women. Nearly 20% of UTIs are found in men.
Patients with OAB and UI have a higher occurrence of Urinary Tract
Infections and early detection is key in better responses to treatments.
Under the aforementioned agreement, ACON Labs will be responsible
for filing the updated brand with the FDA. The process is expected to be
relatively quick, with FDA clearance of the UriVarx™ brand currently
anticipated to take approximately 30 days from the filing date.
“We are very excited about adding the FDA-cleared UTI diagnostic strips
for bladder control and health to our UriVarx™ clinical supplement
offerings,” stated Dr. Bassam Damaj, President and Chief Executive
Officer of Innovus Pharma. “We strongly believe our UriVarx™ customers
will be able to use our FDA cleared UTI test strips to monitor ongoing
bladder infections from the convenience of their homes. We are excited
that Innovus Pharma is a pioneering company in this field. We are
differentiating ourselves by offering clinically-tested supplements and
consumer care products sold in concert with FDA-cleared tests and/or FDA
OTC drugs,” he continued.
As a market leader, ACON Labs offers additional home test kits
and test strips. Innovus Pharma anticipates expanding into other areas
that align with their current product line. In particular, both
companies have discussed additional collaboration on glucometers and
diabetes strips as well as other possibilities.
“We view the agreement with ACON Labs on the FDA cleared UTI
strips as the first phase in our burgeoning relationship. We look
forward to working with ACON Labs to provide us with quality
FDA-cleared diagnostics products and test strips focused on diabetes,
and others, to help our clients optimize their healthcare outcomes
within the confines of their homes,” Dr. Damaj said.
About UriVarx™ Clinical Supplement
UriVarx™ is clinically published to reduce urinary urgency, accidents
and both day and night frequency in OAB and UI patients.
UriVarx™ has undergone two double blind and comparative trials in both
male and female OAB and UI patients. The clinical results include:
1. Reduction of ~56% in Urge Incontinence;
2. Reduction of ~66% in
3. Reduction of ~61% in Urinary Urgency;
Reduction of ~33% in Urinary Frequency meaning the total average urinary
frequency was in the normal/ideal range after two months of use; and
Reduction of ~46% in Nocturia.
According to the U.S. National Association for Continence (“NAFC”), OAB
is a medical term that describes various symptoms caused by involuntary
bladder spasms, including urinary frequency, especially at night, and
urgency with or without involuntary leakage. These symptoms may occur
without obvious cause or be secondary to certain diseases of the nervous
system. The NAFC estimates that nearly 25 million Americans suffer from
some form of OAB or incontinence. The condition, with frequency and
urgency only, affects men and women of all ages, although most are under
About the UriVarx™ FDA Cleared UTI Test
The UriVarx™ UTI test strips are FDA-cleared tests for the detection of
leukocytes and nitrites to aid in the screening of Urinary Tract
Infection for self-testing. The test has undergone clinical trials and
the results can be seen in two minutes.
According to a study by Grand View Research (April 2016), the market
size for urinalysis tests in 2015 worldwide was $1.37 billion and in
North America was $510 million of which UTI testing represented a large
percentage of that market.
About Innovus Pharmaceuticals, Inc.
Headquartered in San Diego, Innovus Pharma is an emerging OTC consumer
goods and specialty pharmaceutical company engaged in the
commercialization, licensing and development of safe and effective
non-prescription medicine and consumer care products to improve men’s
and women’s health and vitality and respiratory diseases. Innovus Pharma
delivers innovative and uniquely presented and packaged health solutions
through its (a) OTC medicines and consumer and health products, which we
market directly, (b) commercial partners to primary care physicians,
urologists, gynecologists and therapists, and (c) directly to consumers
through our on-line channels, retailers and wholesalers. The Company is
dedicated to be a leader in developing and marketing new OTC and branded
Abbreviated New Drug Application (“ANDA”) products, men’s and women’s
health supplements, related diagnostics and medical devices. The Company
is actively pursuing opportunities where existing prescription drugs
have recently, or are expected to, change from prescription (or Rx) to
OTC, as well as related products.
For more information, go to www.innovuspharma.com;
About ACON Laboratories, Inc.
ACON Laboratories Inc. is a privately-owned Diagnostics and
Medical Device company, which was founded in 1995, with its headquarters
located in San Diego, California. ACON Laboratories, Inc.
produces a broad range of medical diagnostic and healthcare products
that are sold in over 130 countries worldwide. The company continues to
expand its product lines through extensive research and development,
with the goal of helping improve the health and well-being of patients
around the world. ACON’s manufacturing facility is a US FDA
registered manufacturer of rapid diagnostic and healthcare products.
Innovus Pharma’s Forward-Looking Safe Harbor:
Statements under the Private Securities Litigation Reform Act, as
amended: with the exception of the historical information contained in
this release, the matters described herein contain forward-looking
statements that involve risks and uncertainties that may individually or
mutually impact the matters herein described for a variety of reasons
that are outside the control of the Company, including, but not limited
to, projected revenues from the UriVarx™® product in the United States
if approved in that country, estimated market for its products, and
statements about achieving its other development, growth,
commercialization, financial and staffing objectives. Readers are
cautioned not to place undue reliance on these forward-looking
statements as actual results could differ materially from the
forward-looking statements contained herein. Readers are urged to read
the risk factors set forth in the Company’s most recent filing on Form
S-1, annual report on Form 10-K, subsequent quarterly reports filed on
Form 10-Q and other filings made with the SEC. Copies of these reports
are available from the SEC’s website or without charge from the Company.
Emerging Markets Consulting, LLC
James S. Painter III, 407 340 0226