Sonoma Pharmaceuticals Announces Newly Published Results from Study of Hypochlorous Acid in Management of Hypertrophic and Ke...
October 25 2018 - 6:05AM
Sonoma Pharmaceuticals, Inc. (Nasdaq: SNOA), today announced newly
published results from a study into the use of the company’s
proprietary Performance Stabilized HOClTM (hypochlorous acid) for
the management of scars. The newly published data, sponsored by
Sonoma Pharmaceuticals, was presented in a lecture/poster by Dr.
Mark Steven Nestor, MD, PhD, Director of the Center of Cosmetic
Enhancement and Director of the Center for Clinical and Cosmetic
Research; both within the Miami Miller School of Medicine in Miami,
Florida. Dr. Nestor presented the poster at the Beaver Creek
Dermatology Conference in Beaver Creek, Colorado in August 2018.
The original double-blind, multi-center randomized scar study
was conducted in 2013 by Alicia D. Bucko, DO, CPI; Zoe Draelos, MD;
Janet C. Dubois, MD and Terry Jones, MD. The 40-patient study was
conducted at four U.S. investigative sites over 16 weeks, ending
March 2013. Qualified scars included linear or widespread
hypertrophic or keloid scars. Scars were evaluated using the
validated Vancouver Scar Scale (VSS). The investigator and each
subject (40 subjects) completed the VSS and symptom evaluators at
each of the five evaluation visits. Overall efficacy was assessed
with the Investigator Global Assessment (IGA) at baseline and again
on day 56 (end of treatment) and on day 112.
The primary objective of the scar study was to compare the
results of treating hypertrophic and keloid scars with Sonoma’s
proprietary Performance Stabilized HOCl with silicone gel versus
ordinary silicone gel. Silicone-based products are currently
recommended as the first-line option for preventing and treating
excessive scarring after surgery or trauma.
HOCl plus silicone gel and plain silicone gel both improved
hypertrophic scar parameters including vascularity, pliability,
height, pain and itch. The mean VSS among subjects treated with
HOCl plus silicone gel decreased from 6.2 at baseline to 3.5 at day
112. The mean VSS among subjects treated with plain silicone gel
decreased from 5.78 at baseline to 3.94 at day 112. The mean VSS
among subjects decreased by 43.5% and 31.8% among subjects treated
with the HOCl plus silicone gel and silicone gel, respectively. The
IGA scores for HOCl plus silicone gel were superior to silicone gel
alone at a 95% confidence level at both 84 and 112 days. In
summary, HOCl plus silicone gel is more effective for treating
hyperthrophic scars and demonstrated superiority over silicone gel
as a single agent. Further information on the study and the newly
published data can be accessed at
http://ir.sonomapharma.com/static-files/71a75ee7-27cb-477a-9a9a-90cd610e6eb0.
“These results are most compelling,” Dr. Mark Steven Nestor
said. “We know the vast majority of scars can be effectively
managed if treated consistently and with the latest technologies
available. These HOCl-based products are a potentially
landscape-altering shift in scar treatment moving forward and will
likely become a standard of care.”
The Performance Stabilized HOCl-based Celacyn® Rx Scar
Management Gel from Sonoma Pharmaceuticals is now available by
prescription through leading U.S. dermatologists. For more
information or to order visit:
http://intraderm.com/celacyn-scar-management-gel/.
Scar Treatment MarketAccording to a 2003 report
by Frost & Sullivan, it is estimated that 62 million scars
are formed each year in the United States. There are about 93
million people in the United States suffering from scars,
out of which about 169 million scars can be characterized as
hypertrophic (raised) and keloid (red colored) scars. The raised
and red scars market forms the primary target for the scar therapy
products. Annually, about 600,000 visits for burns and more than
2.6 million emergency room visits for cut injuries, this forms the
potential market for the scar therapy products. The statistics show
that out of 6.2 million reconstructive procedures performed on
patients in a year, 250,000 surgeries are related with scar
revisions.
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 “managed,”
“treated,” and “become,” 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 meet the Company’s cash needs, 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™ is a trademark or 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.Bob MillerCFO(925) 787-6218
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