FDA Cleares BRH-A2 to Treat Serious Wounds Using Electric Fields and Ultrasound

BRH Medical, a company based in Jerusalem, Israel, won FDA clearance for its BRH-A2 system that uses ultrasound and electricity to heal deep and chronic wounds. Using the two methods allows to speed up the healing of the wound while reducing pain during treatment. Both electric fields and ultrasound energy are delivered into and under the wound, treating it from all sides. To cover a wide range of treatment options in one session, the device varies the frequency and strength of the electric and ultrasound stimulations. The device can be used in combination with other therapeutic methods, such as negative pressure therapy.

Since most patients receive multiple treatments, the device includes a patient and wound management system for keeping track of how things are progressing over time. It can also be used to measure ulcers, including ones with poorly defined edges.

More about BRH Medical’s technology, according to its website:

The BRH-A2 device implements a unique combination of therapeutic ultrasound and electrostimulation in modulating cycles of independent and joint activity. Determining the most effective levels of stimulation for optimal treatment parameters are the result of hundreds of hours of scientific experimentation and laboratory simulations.

The BRH-A2 device combines the two modalities, and modulates them both individually and in combination during the treatment period. The result of this unique activity alters the overall effect on the cellular structures and also modifies the directions of cellular and subcellular aggregation.

A proven effect of ultrasound is to stimulate fibroblasts to create collagen, and also to lay the new collagen in a more ordered pattern, resulting in a better weave for epithelialization. Electrostimulation is known to pull taut the fibroblasts and resultant collagen,  yielding a stronger weave. The end result of using the two technologies is a more ordered and tighter collagen weave.