HAIFA, Israel, October 22, 2015 /PRNewswire/ --
INSIGHTEC, the leader in MR guided Focused Ultrasound (MRgFUS) therapy announces today that it has submitted a pre-market approval application (PMA) to the U.S. Food and Drug Administration (FDA) for its Exablate Neuro treatment of Essential Tremor.
Exablate Neuro uses high intensity focused ultrasound to thermally ablate the target tissue and continuous MRI to visualize the anatomy, plan treatment and monitor treatment outcomes. In the brain, MRgFUS is used to perform a non-invasive thalamotomy through intact skull to relieve tremor in patients with Essential Tremor.
Essential tremor is the most common movement disorder, affecting more than five million people in the United States, and millions more worldwide. It is a progressive and debilitating neurological condition that causes a rhythmic trembling of the hands, head, voice, legs or trunk.
Exablate Neuro noninvasive ablation was investigated as a treatment alternative for these patients. The PMA submission was based on a two arm randomized controlled trial comparing patients undergoing Exablate MRgFUS treatment with patients undergoing a placebo treatment. Patients in the placebo treatment arm were later allowed to undergo an Exablate Neuro treatment. The FDA granted the Expedited Access Pathway designation.
"This is another major achievement, our third clinical indication submitted for FDA approval and the first PMA for Neurosurgery," said Dr. Kobi Vortman, CEO and Founder of INSIGHTEC. "This represents our continued commitment to transform MRgFUS from an investigational technology to a standard of care treatment option for neurological patients," he concluded.
"This is the first transcranial MRgFUS treatment being reviewed for FDA approval. It follows years of development with significant technological breakthroughs," said Eyal Zadicario INSIGHTEC's VP R&D and Neuro Program. "We believe that this is only the starting point in many neurosurgery developments to come our way in the coming future," he concluded.
Funding for the study has been provided by the Focused Ultrasound Foundation and BIRD (US-Israel Binational Industry R&D) and INSIGHTEC.
Participating medical sites:
University of Virginia, Stanford University Hospital, University of Maryland, Brigham and Women's Hospital, Swedish Medical Center, Yonsei University College Of Medicine (Korea), Sunnybrook Hospital, Tokyo Women's Medical University, Tremor Research Group - Core Lab.
INSIGHTEC is a world leader in MR-guided Focused Ultrasound (MRgFUS). The Company, founded in 1999, develops and distributes a noninvasive therapy platform that is transforming medicine. INSIGHTEC is continuously expanding its applications ranging from functional neurosurgery to oncology and gynecology. MRgFUS is embraced by world-renowned physicians in more than 120 leading medical facilities around the world, who value both its clinical and economic value.
The Company has received numerous innovation awards, including the Wall Street Journal, European Union and TIME magazine among others. INSIGHTEC is privately held by GE Healthcare, Elbit Imaging, York Capital Management, GEOC Hengtong Investment Limited Partnership and MediTech Advisors.
For more information, please visit: http://www.insightec.com
Xen Mendelsohn Aderka
VP of Marketing