Insightec, a global healthcare company focused on creating the next generation of patient care, today announced that it has received FDA IDE approval to conduct a pivotal study to evaluate staged, bilateral Focused Ultrasound treatment of patients with medication-refractory Essential Tremor.
| MIAMI and HAIFA, Israel, Feb. 4, 2021 /PRNewswire/ -- Insightec, a global healthcare company focused on creating the next generation of patient care, today announced that it has received FDA IDE approval to conduct a pivotal study to evaluate staged, bilateral Focused Ultrasound treatment of patients with medication-refractory Essential Tremor. Fifteen subjects have been recruited to the study to date.
Focused Ultrasound guided by magnetic resonance imaging (MRI) allows treating a target deep in the brain with no incisions. Insightec’s Exablate Neuro Focused Ultrasound device received U.S. Food and Drug Administration approval in 2016 to treat medication-refractory Essential Tremor in one hand, or unilaterally. The current clinical trial is evaluating the safety and efficacy of bilateral (both sides of the body) treatment in subjects 22 years or older with a diagnosis of medication-refractory Essential Tremor and who had unilateral Focused Ultrasound treatment at least nine months earlier. “When Essential Tremor patients have significant tremor on both sides of their body, a staged, bilateral Focused Ultrasound procedure may offer clinical benefit. This is an important study to evaluate a second Focused Ultrasound treatment performed at least 9 months after the first arm was treated,” commented Howard Eisenberg, MD, the Raymond K. Thompson, MD Chair in Neurosurgery, Professor, Department of Neurosurgery, University of Maryland School of Medicine, and neurosurgeon at the University of Maryland Medical Center. Currently, the clinical trial (NCT04112381) is being conducted at the University of Maryland School of Medicine, Weill Cornell Medicine, University of Pennsylvania, and University of Virginia with additional centers planned. “Incisionless surgery is helping people living with debilitating tremor return to a life of independence,” said Maurice R. Ferré MD, Insightec CEO and Chair of the Board of Directors. “We will continue to collaborate with leading medical centers around the globe and support clinical research to expand treatment options for improved quality of life and quality of care.” Media Contact: Lyndsay Isaksen About Insightec Insightec is a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy. The company’s Exablate® Neuro platform uses Focused Ultrasound, guided by MRI, to provide tremor relief to patients with Essential Tremor and Tremor-Dominant Parkinson’s Disease. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. Insightec is headquartered in Haifa, Israel, and Miami, with offices in Dallas, Shanghai and Tokyo. For more information, please visit: www.insightec.com. Forward-looking Statements This document contains forward-looking statements regarding, among other things, plans, expectations, and future events. In some cases, forward-looking statements can be identified by the following words: “may,” “can,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “promise,” “continue,” “ongoing,” or the negative of these terms. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. Any forward-looking statement is based on information available to INSIGHTEC as of the date of the statement. All written or oral forward-looking statements attributable to INSIGHTEC are qualified by this caution. INSIGHTEC does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in INSIGHTEC’s expectations. “Exablate,” and “Exablate Neuro,” as well as the “INSIGHTEC” logo, whether standing alone or in connection with the word " INSIGHTEC”, are protected trademarks of INSIGHTEC.
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