SANUWAVE Health Announces Regulatory Clearance for dermaPACE in Mexico by the Federal Commission for Protection against Sanitary Risks (COFEPRIS) - Seite 2

About Chronic Wounds in Mexico

In Mexico, the compound annual growth rate (CAGR) in wound care in general is projected to be 6.72% for the next five years.  The key contributors to the market growth are an increasing older population and the growing burden of chronic wounds.  According to the National Council for the Evaluation of Social Development Policy 2018, approximately 7.8% of the Mexican population are aged 65 and above.¹ The International Diabetes Federation data, the prevalence of diabetes among Mexican population aged between 20 and 79 years was approximately 10.8% in 2010 and significantly increased to 13.5% in 2019.  Furthermore, it is well known that chronic venous disease (CVD) is a prevalent disease in the Mexican population. Up to 67.8% of Mexicans have some degree of the disease, and out of those, according to the Vein Consult Study, 2.5% of them have Stages C5 and C6, which makes them prone to develop chronic venous ulcers.²  Currently, there are no effective curative treatments for various chronic wounds being utilized in Mexico, which has led to high rates of lower limb amputations. 

About the dermaPACE System

The dermaPACE System is a novel medical system based on shockwave technology, which has been used for nearly 30 years in lithotripsy procedures (destruction of kidney stones) and later in orthopedic treatments.  These early lithotripsy and orthopedic devices provided the earliest evidence that there was an effect on wound healing. Pulsed Acoustic Cellular Expression (PACE) Technology was developed based on this evidence, and the dermaPACE System is the first to utilize PACE-specific proprietary protocols for wound treatment.  The dermaPACE System treatment must be administered by a healthcare professional.  The dermaPACE System is FDA cleared for the treatment of diabetic foot ulcers (DFU) and it is the first and only system based on focused electrohydraulic shockwave principle cleared by the FDA for such indication.   For international markets, the dermaPACE System is CE Marked in Europe for advanced wound care indications and in Canada carries a Health Canada Medical Device class II License. The dermaPACE System is currently licensed or approved for advanced wound care indications in Brazil, Mexico and dozens of countries and regions around the world.