2017年4月21日

INSIGHTEC

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

PR68259

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

    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. 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
[
https://www.nicklauschildrens.org/news-and-events/press-releases/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
    Insightec@rlyl.com

SOURCE: INSIGHTEC