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


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


HAIFA, Israel, Apr. 21, 2017, /PRNewswire=KYODO JBN/ --

    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. Ferre 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




    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:

    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


    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


    Media Contact:

    Carolyn Tiernan

    Red Lorry Yellow Lorry for INSIGHTEC

    +1(617)237-0922 x 411