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INSIGHTEC: First Patient with Benign Brain Tumor has Focused Ultrasound Procedure at Nicklaus Children’s Hospital

- INSIGHTEC congratulates Nicklaus Children's Hospital, part of the Miami Children's Health System, for performing the first focused ultrasound procedure on a 21-year old patient suffering seizures associated with a benign hypothalamic hamartoma brain tumor.

Hypothalamic hamartoma is a rare, benign (non-cancerous) brain tumor that can cause different types of seizures, cognitive problems or other symptoms. While the exact number of people with hypothalamic hamartomas is not known, it is estimated to occur in one out of 200,000 children and teenagers worldwide.

The medical team at Nicklaus Children's Hospital is performing MR-guided Focused Ultrasound (MRgFUS) using the Exablate Neuro system as part of an FDA-approved feasibility study. The goal of the pilot study is to gather the preliminary safety profile of this incisionless ablative treatment for benign centrally-located intracranial tumors in pediatric and young adults. The MRgFUS procedure involves applying high energy ultrasound waves guided by magnetic resonance imaging (MRI) to heat and ablate the target tumor, without impacting the scalp, skull or surrounding healthy brain tissue.

The medical and research team at Nicklaus Children's is led by Dr. John Ragheb, Director of Division of Neurosurgery; Dr. Travis Tierney, Principal Investigator; Dr. Ian Miller, Director of Epilepsy Program; Dr. Sanjiv Bhatia, neurosurgeon; Dr. Nolan Altman, Director of Radiology; Dr. Prasanna Jayakar, Chairman of the Brain Institute at Nicklaus Children's Hospital; and Dr. Jennifer McCafferty, Director of Research, Miami Children's Research Institute.

"This breakthrough first procedure sets the stage for us to provide incisionless surgery for young patients with benign centrally-located brain tumors. Our team is encouraged by the potential of focused ultrasound technology to positively impact lives," said Prasanna Jayakar, MD, PhD, Chairman of the Brain Institute at Nicklaus Children's Hospital.

"We applaud the team at Nicklaus Children's for their commitment to treating children with various brain conditions. Their pioneering research with our MRgFUS technology offers hope that significant groups of pediatric patients will be able to undergo treatment without any surgical incision, minimizing or eliminating the risk of infection or other surgical complications," said Maurice R. Ferré MD, CEO and Chairman of INSIGHTEC.

"The needs of pediatric patients emphasize some of the important advantages of focused ultrasound. It is incisionless, avoids ionizing radiation, offers less risk of infection and disruption of adjacent normal tissue than surgery, and patients often return to normal activities within days," says Focused Ultrasound Foundation's Chief Medical Officer, Tim Meakem, MD.  "These benefits are especially important in neurosurgery, and researchers around the world are investigating other areas where this innovative care could improve outcomes for patients of all ages. The Foundation congratulates the entire team of Nicklaus Children's Hospital and INSIGHTEC for this breakthrough achievement."

Funds for the study have been provided by the Focused Ultrasound Foundation. Regulatory sponsorship has been provided by INSIGHTEC.

To read the Nicklaus Children's Hospital press release, please click here .

About INSIGHTEC 

INSIGHTEC is the world leader and innovator of MR-guided Focused Ultrasound (MRgFUS). The company's non-invasive therapy platforms, Exablate and Exablate Neuro, are proven technology based on sound clinical evidence for treating essential tremor, painful bone metastases and uterine fibroids. The company is dedicated to improving patient lives by collaborating with physicians, medical institutions, academic researchers and regulatory bodies around the world. For more information, please visit: http://www.insightec.com.

About Nicklaus Children's Hospital 

Founded in 1950 by Variety Clubs International, Nicklaus Children's Hospital - part of Miami Children's Health System - is South Florida's only licensed specialty hospital exclusively for children, with more than 740 attending physicians and over 220 pediatric subspecialists. The 289-bed hospital is renowned for excellence in all aspects of pediatric medicine with several specialty programs routinely ranked among the best in the nation by U.S. News & World Report. The hospital is also home to the largest pediatric teaching program in the southeastern United States and has been designated an American Nurses Credentialing Center (ANCC) Magnet facility, the nursing profession's most prestigious institutional honor. For more information, please visit http://www.nicklauschildrens.org.

About the Focused Ultrasound Foundation 

The Focused Ultrasound Foundation was created to improve the lives of millions of people worldwide by accelerating the development of focused ultrasound, an early-stage, noninvasive, therapeutic technology with the potential to transform the treatment of many serious medical disorders. The Foundation works to clear the path to global adoption by coordinating and funding research, fostering collaboration, and building awareness among patients and professionals. It is dedicated to ensuring that focused ultrasound finds its place as a mainstream therapy for a range of conditions within years, not decades. Since its establishment in 2006, the Foundation has become the largest non-governmental source of funding for focused ultrasound research. More information can be found at http://www.fusfoundation.org.

Media Contact:Carolyn Tiernan Red Lorry Yellow Lorry for INSIGHTEC +1(617)237-0922 x 411Insightec@rlyl.com

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