The pipeline for clinical studies using focused ultrasound to treat brain conditions is more robust than ever. Neal Kassell, MD, chairman of the Focused Ultrasound Foundation says this is key to his positive 2013 outlook for the field of focused ultrasound.
Asserting that the brain is the most complex and most difficult organ to treat, he says, “Developing safe and effective treatments for brain conditions is the best way to validate focused ultrasound technology and to accelerate its application throughout the body. It doesn’t take an enormous leap of faith to understand that if you can treat something deep in the brain with extreme precision and accuracy—safely and effectively—in a patient who’s wide awake, with no anesthesia, that you can use focused ultrasound in other areas of the body.”
Neurosurgeon Jeff Elias, MD, neurological physical therapist Diane Huss, PhD and their colleagues at UVA expect to complete the treatment phase of the Parkinsonian tremor study and launch the pivotal trial for Essential Tremor during 2013.
Two things occurred in late 2012 to set the stage for the important brain indication advancements expected this year. First, InSightec – the only vendor with a focused ultrasound brain system – received CE-marking for its ExAblate Neuro. Second, the company’s new CEO, Jim Davis, indicated that rapid progress in developing treatments for neurological disorders is one of his top priorities. As Davis noted, “While we are thrilled with our recent CE marking, we are about to embark on some very important clinical trials that will provide additional evidence around the clinical efficacy of the procedures.”
Brain indications – what’s expected in 2013
- Launch of multi-center pivotal clinical trial for Essential Tremor led by University of Virginia (UVA) neurosurgeon W. Jeffrey Elias, MD.
- Commencement of Focused Ultrasound Foundation-funded clinical studies for brain tumors and Parkinsonian dyskinesia.
- Conclusion of the treatment phase of the Foundation-funded Parkinsonian tremor study at UVA.
- Conclusion of the Foundation-funded Essential Tremor pilot clinical study at Sunnybrook Health Sciences Centre in Canada
- Publication of the ground-breaking Foundation-funded Essential Tremor pilot clinical trial conducted at UVA from 2011-2012.
- Growth in the number of sites equipped to perform focused ultrasound brain treatments and participate in clinical trials.
Other key developments on the horizon:
- Men’s Health – Focused ultrasound device makers EDAP and SonaCare Medical (formerly U.S. HIFU) move closer to entering the American prostate cancer treatment market by submitting Premarket Approval filings.
- Women’s Health – Publication of data from Foundation-funded national survey sheds new light on women’s uterine fibroid treatment preferences.
- Foundation milestones –
– Research Award Program funding passes the $3 million mark.
– Journal of Therapeutic Ultrasound (co-sponsored with the International Society for Therapeutic Ultrasound and BioMed Central) begins publication.– Announcement of two new Focused Ultrasound Centers of Excellence.
Written by Ellen C., McKenna