Medical device developer BRH Medical said today it won FDA 510(k) clearance for its BRH-A2 device designed to reduce pain and improve deep wound healing through the use of ultrasound and electric fields.
The Israel-based company’s BRH-A2 device is designed to engage and stimulate the wound from below the wound bed using both an ultrasound and electric field system which varies in frequency and intensity over the course of the treatment.
“It has always been my desire to develop a product that would truly help cure people. Our grateful patients are proof of the effectiveness of the technology,” CTO & device inventor Ilan Feferberg said in prepared remarks.
The portable wound treatment system is designed to be used together “with any treatment modality,” BRH Medical said.
“FDA clearance for the BRH-A2 represents an important milestone for our company and provides an important key to opening the huge potential of the market in the United States for our product. We are now exploring the most efficient way to penetrate the market, and are currently focusing on identifying strategic partnerships. The market for products that ease the pain of chronic wounds is large and growing. Our vision is to become the gold standard for treatment of chronic wounds of all kinds, including pressure wounds, diabetic leg wounds and wounds caused as a result of ischemia,” CEO Motti Oderberg said in a prepared statement.