Sonoma Pharmaceuticals, Inc. (NASDAQ: SNOA) shares were rising 11.90% to $3.95 as of this morning’s last pre-market check. SNOA has made a number of encouraging announcements in the last week, which have led to this notable increase in stock value.
New MHRA Registrations Signal the UK Market’s Growth
The Medicines & Healthcare medicines Regulatory Agency (MHRA) recently granted Sonoma Pharmaceuticals permission to register its production facility and five important medicines in the UK. The recently authorized goods include a skin exfoliator, wound hydrogel, a variety of scar management solutions, and a wound irrigation solution based on hypochlorous acid.
With this registration, Sonoma will be able to reach a wider audience and increase its market share in the UK by introducing its cutting-edge Microcyn-based products. The business was excited about the prospects for expansion this clearance offers in the dermatology and wound care industries.
Adopting EU Medical Device Regulations with Success
Sonoma Pharmaceuticals has accomplished a significant regulatory milestone in Europe in addition to registering in the UK. Four of the company’s products were successfully converted to conform to the Medical Device Regulation (MDR) of the European Union. These consist of Pediacyn for atopic dermatitis, Microdacyn60 Wound Care, Microdacyn60 Hydrogel, and the scar gel Epicyn.
Strict requirements for the performance and safety of medical devices are mandated by the MDR, which took the place of the old Medical Device Directive in 2017. A noteworthy accomplishment is Sonoma’s early adherence to these new rules, which guarantees that its goods will satisfy all safety and legal criteria before the December 2028 date.
Evidence of Regulatory Readiness and Product Safety
Sonoma’s dedication to product safety and regulatory vigilance is demonstrated by the successful registration and classification of its products as Class IIb medical devices in Europe. The company’s solid clinical data and capacity to adjust to changing international requirements are clearly demonstrated by the shift to MDR compliance.