Sonoma Pharmaceuticals, Inc., (Nasdaq: SNOA) on Thursday said it secured U.S. Food and Drug Administration approval for a gel designed to fight infection and speed healing after laser skin therapy and chemical peels.
The news helped boost the price of the Petaluma-based company's stock early in the trading session.
The new 510(k) clearance from the FDA is for an antimicrobial gel intended for the management of post-nonablative laser therapy procedures and post-microdermabrasion therapy as well for use following superficial chemical peels, according to the Petaluma-based company. It may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns.
The products are marketed under the name Intraderm Pharmaceuticals (intraderm.com, 855-317-1107), a division of Sonoma Pharmaceuticals.
"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."
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.
"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," said clinical tester Michael Gold, a board-certified dermatologist and cosmetic surgeon, in a statement. He founded Gold Skin Care Center, Advanced Aesthetics Medical Spa, The Laser & Rejuvenation Center, and Tennessee Clinical Research Center, all located in Nashville, Tennessee. "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."
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 percent 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).
Formerly Oculus Innovative Sciences, Sonoma Pharmaceuticals makes treatments for dermatology, advanced tissue care and animal health. It claims its products have been used to treat over 5 million patients.
The price of Sonoma Pharmaceuticals stock was up 30 percent in presession trading Thursday and was up 12.45 percent to $4.15 a share just before 10 a.m. Pacific Time. The company's stock price is down 40 percent from $6.97 12 months ago.