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HistoSonics Starts Clinical Trial For Non-Invasive Prostate Treatment

ANN ARBOR (WWJ) -- Ann Arbor-based HistoSonics Inc. announced the first experimental treatment of a research volunteer with its Vortx RX device, designed to treat benign prostate enlargement non-invasively.

The Vortx RX is based on histotripsy technology, a non-thermal focused ultrasound therapy that mechanically liquefies targeted tissues.

Urologist Timothy Schuster, M.D., of ProMedica Genito-Urinary Surgeons in Toledo, Ohio performed the first Vortx RX experimental treatment.

The Vortx RX is an investigational device and is limited by law to investigational use by qualified investigators in the U.S. and Canada.

BPH is a common condition in mature men that is caused by enlargement of the prostate. The condition causes difficult and frequent urination and, if left untreated, can lead to significant kidney problems. More than 50 percent of men over 50 years of age and 80 percent of men 80 or older are affected by BPH. Over 2 million men in the U.S. seek treatment annually. Most are treated with drugs; however, approximately 350,000 require surgical or minimally invasive procedures each year.

The U.S. pilot clinical study will enroll a total of 25 men with BPH symptoms at two sites. The primary goal of this pilot clinical study is to demonstrate safety of the Vortx RX in treatment of BPH.

A similar pilot study is getting under way in Canada that will enroll up to 20 men.

Established in 1986, ProMedica is a locally owned, nonprofit healthcare organization serving northwest Ohio and southeast Michigan. ProMedica includes 11 member and affiliate hospitals, oversees 306 facilities in 27 counties and provides care for 2.6 million patient visits annually.

HistoSonics is developing Vortx RX systems to deliver histotripsy as a non-invasive, image-guided focused ultrasound therapy that mechanically homogenizes target tissue resulting in cellular destruction. Histotripsy technology was originally developed at the University of Michigan where pre-clinical research within the Departments of Biomedical Engineering and Urology has demonstrated feasibility for tissue ablation throughout the body, blood clot thrombolysis for treatment of deep vein thrombosis, cardiac tissue ablation and lithotripsy. Histotripsy technology and intellectual property have been licensed from the University of Michigan.

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