Sonoma Pharmaceuticals Receives U.S. FDA Clearance of Loyon® Skin Descaler for Relief of Scaling Associated with Various Der...
March 29 2017 - 3:05AM
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 a new 510(k) clearance from the U.S. Food and Drug
Administration (FDA) for the company’s newest product, Loyon® Skin
Descaler. Loyon is intended to manage skin scaling
experienced with various types of dermatoses.
Loyon Skin Descaler is a unique and patented combination of the
dry emollient Cetiol® CC and the medical silicone oil dimethicone.
The product is easily applied and spreads exceptionally well into
the cracks and crevices of the scale due to its low surface
tension. U.S. commercialization via Sonoma’s dermatology
division IntraDerm Pharmaceuticals’ 30-plus-person direct sales
team is slated for summer 2017.
“Loyon Skin Descaler has demonstrated an impressive level of
efficacy in the management of multiple dermatoses including
psoriasis capitis and seborrheic dermatitis since first being
commercialized in Europe in 2014,” said Jeffrey Day, president of
IntraDerm Pharmaceuticals. “Nearly a quarter of the U.S. population
is afflicted with scaling associated with various skin dermatoses
and we believe this product, once launched, will provide this
community with a most novel tool for assisting with scale removal
in their patient populations.”
Market Size It is estimated that 25% of
the general population has some degree of scaling associated with
skin dermatoses. “Although the diagnosis is often overlooked
and undervalued, the treatment of the symptoms is just as integral
as slowing the process,” said Neal Bhatia, MD., director of
clinical dermatology, Therapeutics Clinical Research. “The
presentation may be more aggressive in patients with HIV,
neurologic disorders, infants and the elderly. More
importantly, options for symptom control are limited and
dermatologists are in need of new options.”
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 “believe,”
“achieve,” and “strive,” 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, the
Company may not meet its future capital needs, 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 including its annual report on Form 10-K for
the fiscal year ended March 31, 2016. The Company disclaims
any obligation to update these forward-looking statements, except
as required by law.
Sonoma Pharmaceuticals® is a registered trademark 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 McFadden
VP of Public and Investor Relations
(425) 753-2105
dmcfadden@sonomapharma.com
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