Sonoma Pharmaceuticals Announces FDA Approval for Antimicrobial Post-Therapy Gel
PETALUMA, Calif., April 05, 2018 (GLOBE NEWSWIRE) -- 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 Resurfacing
According 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.
Except 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.
VP of Public and Investor Relations
Released April 5, 2018