Insightec, an Israeli healthcare company specializing in treatments for essential tremor, as well as Parkinson’s disease and prostate disease, has received FDA approval for its study confirming the first Focused Ultrasound treatment for essential tremor.
Essential tremor is a nervous system condition that causes involuntary and rhythmic shaking typically in the hands.
There is currently no cure for essential tremor. Insightec’s ultrasound treatment has shown to be significantly more effective and less invasive than other available drug based treatments.
Insightec’s ultrasound technology uses sound waves to target and remove tissue with no incisions with a significantly lower risk of infection, and has been used to perform over 11,000 procedures worldwide.
The company’s five year study is the largest long-term, follow-up study of focused ultrasound surgery for essential tremor to date.
The study monitored the participants’ tremor conditions over the course of five years while undergoing Insightec’s ultrasound treatment.
The results of the study demonstrated a sustained and significant improvement in participants’ tremor severity, a high overall improvement in quality-of-life, and no progressive or delayed complications.
“The FDA approval validates the years of work that we have invested into using Focused Ultrasound as a front-line therapy for ET,” said Maurice R. Ferré, MD, CEO and the Chairman of the Board of Directors at Insightec.
“It also substantiates that using MR-guided focused ultrasound to treat essential tremor is safe and effective, as well as long-lasting. We look forward to making further progress in finding more uses for focused ultrasound and building on the success of the treatment of essential tremor.”
The study was published in Journal of Neurosurgery, following the original 2016 paper in New England Journal of Medicine.
Insightec is headquartered in Haifa, Israel and Miami, Florida, with offices in Dallas, Texas, Shanghai, China and Tokyo, Japan.