NanoVibronix (NSDQ:NVBXU) said today that it won approval from Health Canada to sell its WoundShield device in Canada. The Elmsford, N.Y.-based company has also won CE mark approval for the device in the European Union.
The WoundShield system is a patch-based ultrasound device that increases local capillary perfusion and tissue oxygenation to facilitate soft tissue regeneration, according to NanoVibronix. The company’s device uses low-frequency ultrasound waves to accelerate wound healing, prevent biofilms from forming and disrupt bacteria colonization.
NanoVibronix’s portfolio of devices, including WoundShield and PainShield, can be administered at home without the help of a medical professional.
“We are very pleased with Health Canada’s approval to sell the WoundShield in Canada,” CEO Brian Murphy said in prepared remarks. “We believe that the Canadian market represents an attractive opportunity for our WoundShield system with more than 280 thousand patients suffering from persistent wounds, while diabetic foot ulcers are estimated to affect 25 percent of patients with diabetes. With chronic wounds affecting 5.7 million patients in the U.S., the total global wound device market is expected to reach $20 billion in 2016. WoundShield has also received a CE Mark for marketing clearance in Europe, where we are focusing on new sales and marketing initiatives. We will also pursue the necessary approvals to commence marketing in the U.S. Our strategy for selling WoundShield in the U.S. and Canada is to find a strong partner in the wound care market.”