In 2007, Dr. Koch with others at IU School of Medicine published on the first 20 patients treated with HIFU in United States [Koch MO, Gardner TA, Cheng L et al. Phase I/II Trial of High Intensity Focused Ultrasound for the Treatment of Previously Untreated Localized Prostate Cancer. J Urol. 2007 Dec;178(6):2366-70.]. The study showed that the treatment had few side effects and had the potential to be an effective treatment option for early-stage prostate cancer. They found that ablation of the whole gland can cause temporary swelling and the need for a temporary urinary catheter. This increased the interest in focal or partial-gland ablation. Subsequent studies on HIFU partial gland treatment have demonstrated preservation of erections in close to 90% and a 100% pad-free rate by three months.
The first HIFU system (Sonablate®) was manufactured in Indianapolis in 1996 for a company called Focus Surgery. SonaCare Medical, LLC was established in 2013. Sonablate® became the first device approved by the FDA for HIFU in 2015.