BOULDER, CO - Sonoma Pharmaceuticals, Inc. (NASDAQ:SNOA), a global healthcare company, announced today it has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Microdacyn® Hydrogel. The product, based on the company's patented Microcyn® technology, has been approved for various wound care applications following more stringent biocompatibility testing.
The FDA's clearance allows the hydrogel to be used by healthcare professionals to manage wounds, including dermal irritations, sores, injuries, ulcers, first and second degree burns, and diabetic ulcers. It also permits over-the-counter (OTC) use for minor skin irritations, lacerations, abrasions, and minor burns, including sunburn management.
This new approval includes a specification for the product's packaging, with the 50mL bottles now having a shelf life of 24 months. The expanded clearance and extended shelf life are expected to enhance the product's market viability and accessibility to patients requiring wound care management.
Amy Trombly, CEO of Sonoma, expressed confidence in the safety and efficacy of the company's wound care products, highlighting the successful passing of the FDA's rigorous testing standards. She emphasized the company's dedication to innovation and maintaining high standards for its products.
Sonoma Pharmaceuticals specializes in developing stabilized hypochlorous acid (HOCl) products for a wide array of medical applications, including wound care, eye, oral and nasal care, dermatology, podiatry, animal healthcare, and non-toxic disinfectants. The company asserts that its products are clinically proven to safely reduce itch, pain, scarring, and irritation without damaging healthy tissue.
The company markets its products globally, either directly or through partners, in 55 countries and continues to seek new distribution partnerships. Sonoma Pharmaceuticals is headquartered in Boulder, Colorado, with manufacturing in Guadalajara, Mexico, and European marketing and sales based in Roermond, Netherlands.
This announcement is based on a press release statement, and the information provided does not include any forward-looking statements or speculative content.
In other recent news, Sonoma Pharmaceuticals has seen a flurry of activity in business expansion and product innovation. The healthcare company has amended its Equity Distribution Agreement with Maxim (NASDAQ:MXIM) Group LLC, enabling the continued sale of its common stock. Simultaneously, Sonoma implemented a 1-for-20 reverse stock split to comply with Nasdaq's minimum bid price requirement, reducing its outstanding common shares from around 20 million to about 1 million.
On the product front, Sonoma received FDA clearance for its over-the-counter Microcyn technology-based solution, expanding its dermatology product range. The company also collaborated with EMC (NYSE:EMC_old) Pharma to introduce a redesigned Ocucyn® Eyelid & Eyelash Cleanser, expanding its eye care product line.
In terms of market reach, Sonoma Pharmaceuticals has entered into significant distribution agreements with Medline Industries and a major global healthcare distributor, aiming to extend the reach of its wound care products across the U.S. The company also introduced its MicrocynAH® animal health line to Menards® home improvement stores nationwide and expanded its Microcyn® Negative-Pressure Wound Therapy (NPWT) Solution in the U.S. market.
A recent study underscored the potential of Sonoma's product, Microdox®, in treating urinary tract infections in children with bladder dysfunction. These are the recent developments at Sonoma Pharmaceuticals.
InvestingPro Insights
Sonoma Pharmaceuticals' recent FDA clearance for Microdacyn® Hydrogel comes at a critical time for the company, as revealed by InvestingPro data. Despite the positive regulatory news, SNOA faces significant financial challenges. The company's market capitalization stands at a modest $4.15 million, reflecting investor caution.
InvestingPro Tips highlight that Sonoma is "quickly burning through cash" and "not profitable over the last twelve months." These factors underscore the importance of the new FDA clearance in potentially boosting revenue and improving the company's financial health. The company's revenue for the last twelve months was $13.55 million, with a revenue growth of 11.81%, indicating some positive momentum.
However, the operating income margin of -31.56% suggests ongoing profitability challenges. This aligns with another InvestingPro Tip stating that "analysts do not anticipate the company will be profitable this year." The extended shelf life of the Microdacyn® Hydrogel could help address these issues by potentially increasing sales and improving operational efficiency.
On a positive note, Sonoma "holds more cash than debt on its balance sheet," which may provide some financial flexibility as it seeks to capitalize on this new market opportunity. The company's price-to-book ratio of 0.7 suggests that the stock might be undervalued relative to its assets, which could be attractive to value-oriented investors considering the recent FDA clearance.
Investors seeking a more comprehensive analysis can access additional InvestingPro Tips, with 5 more tips available for SNOA on the InvestingPro platform.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.