Sonoma Pharmaceuticals Receives U.S. FDA Clearance of Loyon® Skin Descaler for Relief of Scaling Associated with Various Dermatoses
PETALUMA, Calif., March 29, 2017 (GLOBE NEWSWIRE) -- 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 Statements
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 (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
Released March 29, 2017