Sonoma Pharmaceuticals, Inc. (Nasdaq: SNOA, warrants SNOAW), a
specialty pharmaceutical company that develops and markets unique
and effective solutions for the treatment of dermatological
conditions and advanced tissue care, today announced it has
received three new regulatory approvals from the United Arab
Emirates Ministry of Health & Prevention.
The first approval is for Acuicyn® eyelid and eyelash hygiene,
an antimicrobial solution (hypochlorous acid) indicated to treat
symptoms and causes of blepharitis on the eyelid and eyelash.
Acuicyn kills microorganisms which can cause irritation, infection
and ocular surface disease.
The second approval is for Microsafe® Oral Care, an antiseptic
mouth and throat rinse (hypochlorous acid) that eliminates harmful
bacteria, viruses and fungi. It relieves symptoms of pain and
inflammation caused by mucositis while accelerating the healing
process of wounds and ulcerations in the oral cavity and
throat.
The final approval is for Sinudox® Nasal Cleansing Spray, an
antimicrobial solution (hypochlorous acid) intended for nasal
irrigation to penetrate, clear and clean the nasal passages and
sinus cavity in post-operative, preventative and symptomatic nasal
care.
“The regulatory process in the United Arab Emirates is extremely
rigorous and considered the gold standard for Southwest Asian
nations. Therefore, securing these three UAE approvals will
certainly open the path to growth and help expedite regulatory
approvals from many other countries in the region,” said Safwan
Abdallah, MicroSafe Group’s director of operations. “We anticipate
launching all three products across the United Arab Emirates in
February 2018.”
“The MicroSafe group continues to build with our proprietary
hypochlorous acid platform throughout the Middle East with
approvals and products across dermatology, wound care,
disinfectants and now personal care. We are very excited for
the MicroSafe Group and honored to be partnered with them,” said
Bruce Thornton, VP of international operations for Sonoma
Pharmaceuticals.
Contact MicroSafe Group at safwan@microsafecare.com for
distribution inquires relative to the Middle Eastern countries.
About BlepharitisBlepharitis is one of the
most common ocular conditions characterized by inflammation,
scaling, reddening, and crusting of the eyelid. This condition
may also cause burning, itching, or a grainy sensation when
introducing foreign objects or substances to the eye. Although
blepharitis is not sight-threatening, it can lead to permanent
alterations of the eyelid margin. The overall etiology is a result
of bacteria and inflammation from congested meibomian oil
glands at the base of each eyelash. Other conditions may give rise
to blepharitis, whether they be infectious or noninfectious,
including, but not limited to, bacterial
infections or allergies. In a survey of U.S.
ophthalmologists and optometrists, 37% to 47% of patients seen by
those surveyed had signs of blepharitis, which can affect all ages
and ethnic groups. One single-center study of 90 patients with
chronic blepharitis found that the average age of patients was 50
years old.
About MucositisMouth and throat sores, also
called mucositis, look like ulcers and can be red and swollen. Pain
from these sores can affect a person’s ability to eat, drink, chew,
swallow, and talk. If one’s immune system is suppressed, they may
be more likely to get an oral yeast infection. Mucositis
is oftentimes a side effect of chemotherapy in cancer patients with
a 40% incidence in standard-dose patients and an 80% incidence in
hematopoietic stem cell transplantation. There is nearly a
100% incidence in patients who receive radiation therapy for neck
and head cancers.
About Chronic SinusitisChronic sinusitis is a
common disease worldwide, particularly in places with high levels
of atmospheric pollution. In the Northern Hemisphere, damp
temperate climates along with higher concentrations of pollens are
associated with a higher prevalence of chronic sinusitis.
Chronic sinusitis is one of the more prevalent chronic illnesses
in the United States, affecting persons of all age groups. The
overall prevalence of CRS in the United States is 146 per 1000
population. For unknown reasons, the incidence of this disease
appears to be increasing yearly. This results in a conservative
estimate of 18-22 million physician visits in the United States
each year and a direct treatment cost of $3.4-5 billion annually.
Chronic sinusitis is the fifth most common disease treated with
antibiotics. Up to 64% of patients with AIDS develop chronic
sinusitis.
About Sonoma Pharmaceuticals, Inc.Sonoma is a
specialty pharmaceutical company that develops and markets unique
and effective solutions for the treatment of dermatological
conditions and advanced tissue care. The company’s
products, which are sold throughout the United States and
internationally, have improved outcomes for more than five million
patients globally by reducing infections, itch, pain, scarring
and harmful inflammatory responses. The company's headquarters are
in Petaluma, California, with manufacturing operations in the
United States and Latin America. European marketing and sales
are headquartered in Roermond, Netherlands. More information can be
found at www.sonomapharma.com.
Forward-Looking StatementsExcept for historical
information herein, matters set forth in this press release
are forward-looking within the meaning of the “safe harbor”
provisions of the Private Securities Litigation Reform Act of 1995,
including statements about the commercial and technology progress
and future financial performance of Sonoma Pharmaceuticals,
Inc. and its subsidiaries (the “Company”). These forward-looking
statements are identified by the use of words such as “continues,”
“expedite,” and “anticipate,” among others. Forward-looking
statements in this press release are subject to certain risks and
uncertainties inherent in the Company’s business that could cause
actual results to vary, including such risks
that regulatory clinical and guideline developments may
change, scientific data may not be sufficient to meet
regulatory standards or receipt of required regulatory clearances
or approvals, clinical results may not be replicated in actual
patient settings, protection offered by the
Company’s patents and patent applications may be challenged,
invalidated or circumvented by its competitors, the available
market for the Company’s products will not be as
large as expected, the Company’s products will not be able to
penetrate one or more targeted markets, revenues will not be
sufficient to fund further development and clinical studies,
as well as uncertainties relative to varying product formulations
and a multitude of diverse regulatory and marketing requirements in
different countries and municipalities, and other risks detailed
from time to time in the Company’s filings with the Securities and
Exchange Commission. The Company disclaims any obligation to update
these forward-looking statements, except as required by law.
Sonoma Pharmaceuticals®, Acuicyn® and Sinudox® are registered
trademarks of Sonoma Pharmaceuticals, Inc. All other
trademarks and service marks are the property of their respective
owners.
Media and Investor Contact:
Sonoma Pharmaceuticals, Inc.Dan McFaddenVP of
Public and Investor Relations(425)
753-2105dmcfadden@sonomapharma.com
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