
The Sonalleve device was approved under a Humanitarian Device Exemption (“HDE”), reducing the need to demonstrate effectiveness in addition to safety. However, in the release, the FDA noted, “Clinical results support the probable benefit of Sonalleve MR-HIFU system for the ablation of painful osteoid osteoma. Efficacy was evaluated in a study of nine patients treated with MR-HIFU, without technical difficulties or serious adverse events. There was a statistically significant decrease in their pain scores within four weeks of treatment. No pain medication usage was achieved in 8 of 9 patients after four weeks.”
“Obtaining the first regulatory approval for Sonalleve® in the U.S. is a significant milestone for the Company and we are making preparations for the US commercial launch in 2021,” said Arun Menawat, Profound’s CEO and Chairman. “Osteoid osteoma is a benign bone tumor that occurs most often in young children and adolescents. It causes severe pain, especially at night. This noninvasive treatment option is like a ‘Star Trek’ story that destroys the tumor without incision or radiation.”

More work is underway for OO. The Foundation is supporting an ongoing comparative trial being conducted at the University of California San Francisco and Stanford University. That study is investigating the use of another focused ultrasound device manufactured by Insightec. Another NIH funded clinical trial is also open at Children's National Hospital and using the Sonalleve device for painful OO treatment in children and young adults.
Focused ultrasound is also FDA approved to treat essential tremor, tremor-dominant Parkinson’s disease, uterine fibroids, pain from bone metastases, and the prostate.
See the FDA Announcement >
See Profound’s Press Release >