Medical device developer Butterfly Medical said today it won CE Mark approval in the European Union for its device designed for the in-office treatment of benign prostate hyperplasia.
The Israel-based company’s device is designed to dilate the prostatic urethra without any surgical incisions or prostate tissue removal. The device then secures tightly to the prostate tissue to prevent migration to move the lobes of the prostate out of the way and improve urine flow.
“We are proud to bring a simple, non-surgical treatment option to the millions of men worldwide afflicted by BPH. With our Butterfly Medical device, they are able to receive treatment quickly and easily in their physician’s office. With market acceptance for our medical approach already demonstrated, our closest competitor was sold for over $1 billion, our European market approval puts us right on the map,” Butterfly Medical CEO Idan Geva said in a prepared statement.
The device and associated procedure are designed to be used under local anesthesia and can take less than 10 minutes, according to Butterfly.
“Butterfly is a great example of our approach at Alon Medtech of building successful companies with our entrepreneurs to bring innovative products to large, high growth markets. The CE approval of the Butterfly device is a very important milestone in the life of the company enabling it to access the European market in the very near future,” Butterfly Medical chair Dr. Shimon Eckhouse said in a press release.