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

Haifa, Israel (ots/PRNewswire) - INSIGHTEC (https://goo.gl/knr17E)
congratulates Nicklaus Children's Hospital
(https://www.nicklauschildrens.org/home), 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 (https://www.nicklauschildrens.org/news-and-events/press-release
s/insightec-focused-ultrasound-surgery) .

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 411

[email protected]

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