JERUSALEM, April 27, 2015 /PRNewswire/ --
BRH Medical, Ltd., today announced that it has successfully completed filing of a Pre-Marketing Notification Application (510k) with the US Food and Drug Administration (FDA) for its BRH-A2 Wound Management System. BRH Medical expects feedback from the FDA during the next quarter and anticipates entering the US market with BRH-A2 following FDA pre-market clearance. Additional pre-market regulatory filings are anticipated during 2015.
Motti Oderberg, CEO for BRH Medical, commented, "We are thrilled to have reached this milestone. We anticipate significant clinical interest in BRH-A2 when we receive pre-market clearance. We look forward to making this important therapy available in the US."
The BRH-A2 has been used outside the US to treat chronic skin ulcers using a modulated combination of therapeutic ultrasound and electrostimulation. BRH Medical believes the result of this therapy alters the overall effect on the cellular structures, potentially accelerating the rate of ulcer wound healing. In clinics across Europe and Israel, the BRH-A2 has shown effectiveness at healing chronic leg ulcers and diabetic foot ulcers. It is currently being tested in a clinical study in the US for the healing of pressure ulcers.
About the BRH-A2 Therapy System
The BRH-A2 combines the benefits of therapeutic ultrasound with electrostimulation and modulates them both individually and in combination during the treatment period. This mode of operation is designed to create a "micro-circulation" effect, a massage-like process within the tissues and blood vessels of the impacted medium, increasing the blood flow to significantly increase the healing rate.
About the Chronic Ulcer Management Market
Chronic leg ulcer is defined as a defect in the skin below the level of knee persisting for more than six weeks and shows no tendency to heal after three or more months. Chronic ulceration of the lower legs is a relatively common condition amongst adults, one that causes pain and social distress. The condition affects 1% of the adult population and 3.6% of people older than 65 years. The common causes are venous disease, arterial disease, and neuropathy.
About BRH Medical, Ltd.
BRH Medical, founded in 2010, a development stage medical device company, is focused on providing innovative therapies for the management and the treatment of development of chronic skin ulcers. The flagship product, BRH-A2, is a medical device which combines therapeutic ultrasound and low frequency electrostimulation to enhance local subcutaneous microcirculation, which the company believes will promote tissue healing. BRH-A2 systems are currently being employed at clinics worldwide to manage and treat patients with chronic skin ulcers.
1. Ulcers, vol. 2013, Article ID 413604, 9 pages, 2013. doi:10.1155/2013/413604
Please visit http://www.brhmedical.com for more information.
Pending 510k, not available for sale within the United States.
Motti Oderberg, CEO
BRH Medical, Ltd.
SOURCE BRH Medical, Ltd.