Sonoma Pharmaceuticals Announces FDA Approval for Antimicrobial Post-Therapy Gel
April 05 2018 - 7:05AM
Sonoma Pharmaceuticals, Inc. (Nasdaq: SNOA, warrants SNOAW), a
specialty pharmaceutical company that develops and markets unique
and effective solutions for management 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 an antimicrobial post-therapy gel. Under the supervision
of a healthcare professional, the new product is intended for the
management of post-non-ablative laser therapy procedures and
post-microdermabrasion therapy as well for use following
superficial chemical peels. It may also be used to relieve itch and
pain from minor skin irritations, lacerations, abrasions and minor
burns.
Dr. Michael Gold, board-certified dermatologist and cosmetic
surgeon, and founder of Gold Skin Care Center, Advanced Aesthetics
Medical Spa, The Laser & Rejuvenation Center, and Tennessee
Clinical Research Center, all located in Nashville, Tennessee,
commented, “This antimicrobial post-treatment gel is a promising
new tool for all dermatologists and aesthetic clinicians who are
looking to better manage medical procedures, post-procedure itch
and pain associated with procedures including laser skin
resurfacing, while promoting enhanced healing and protection
against secondary infections. In our clinical testing to date, we
have seen dramatically improved outcomes with quicker healing times
and less patient discomfort when this advanced technology is added
to our procedure management protocol.”
"This approval is one in a series that further fortifies
Sonoma’s portfolio of innovative antimicrobial dermatology
products,” said Jim Schutz, Sonoma Pharmaceutical's CEO.
“With our continuing efforts working with the FDA to provide
best-in-class products as alternatives to topical steroids and
topical antibiotics, dermatologists should have increased
confidence in our growing product portfolio without concern for the
troubling side effects found in dated
treatments.”
For more information, visit IntraDerm Pharmaceuticals at
www.intraderm.com or phone 1-855-317-1107.
About Laser Skin ResurfacingAccording to the
Clinical, Cosmetic and Investigational Dermatology Journal, medical
and aesthetic skin procedures have seen a steady surge within the
last decade, and a higher demand for skin rejuvenation practices.
In 2013 in the United States, dermatologic surgeons performed over
9.5 million treatments, an almost 22% increase from the previous
year, with a rising number of treatments involving skin resurfacing
in the areas of laser/light/energy-based procedures (2.25 million),
chemical peels (1.1 million), and microdermabrasion (974,000).
Laser skin resurfacing, also known as a laser peel, laser
vaporization and lasabrasion, can reduce facial wrinkles, scars and
blemishes. Newer laser technologies provide surgeons with a new
level of control in laser surfacing, permitting extreme precision,
especially in delicate areas. The laser beam used in laser
resurfacing will remove outer layer of skin, called the epidermis.
It simultaneously heats the underlying skin, called the dermis.
This action works to stimulate growth of new collagen fibers. As
the treated area heals, the new skin that forms is smoother and
firmer. Common side effects include redness of the skin,
swelling of the treated area, itch, pain and moderate irritation
similar to the feeling produced by a mild sunburn.
About Sonoma Pharmaceuticals, Inc.Sonoma is a
specialty pharmaceutical company that develops and markets unique
and effective solutions for management 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. 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, 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 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 McFaddenVP of Public and Investor
Relations(425) 753-2105dmcfadden@Sonomapharma.com
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