Insightec: The Taiwanese Food and Drug Administration (TFDA) Approved Exablate Neuro for the Treatment of Essential Tremor

Haifa, Israel (ots/PRNewswire) -

INSIGHTEC (http://www.insightec.com/), the leader in MR-guided
Focused Ultrasound (MRgFUS) therapy, announced today that the
Taiwanese Food and Drug Administration (TFDA) has approved its
Exablate Neuro system for the treatment of essential tremor in
patients who do not respond to medication.

Exablate Neuro uses focused ultrasound waves to precisely target
and ablate tissue deep within the brain with no incisions. The
treatment is done under Magnetic Resonance Imaging (MRI) guidance
which provides real-time imaging and temperature monitoring. Due to
its non-invasive nature, the treatment carries minimal risk of
surgical complications such as infections or bleeding. The treatment
is performed in a single session with no anesthesia, allowing
patients to experience immediate tremor improvement.

The approval was based on data from a randomized, double-blind
clinical study conducted in eight medical centers in North America
and Asia. The study demonstrated the safety and efficacy of
non-invasive thalamotomy with Exablate Neuro.

"This newly TFDA approved Exablate Neuro provides a new treatment
option for patients with essential tremor without some of the
complications associated with surgery," said Dr. Liu, President of
Taiwan Society for Stereotactic Functional Neurosurgery and
Radiosurgery. "Furthermore, this technology holds promise for
additional neurosurgical procedures," he concluded.

"INSIGHTEC is committed to expanding its footprint into global
markets," said Qui Peng, Country Manager, Greater China at INSIGHTEC.
"We are very pleased that Taiwanese essential tremor patients now
have access to a non-invasive treatment which can greatly improve
their quality of life," he added.

Exablate Neuro is also approved by the Japanese Ministry of
Health, Labor and Welfare (MHLW), Korean Food and Drug Administration
(KFDA) the US Food and Drug Administration (FDA) and Health Canada
for the treatment of essential tremor. Exablate Neuro is also
approved in Europe and Israel.

ABOUT INSIGHTEC

INSIGHTEC is the world leader and innovator of MR-guided Focused
Ultrasound (MRgFUS). The company's non-invasive 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

Media Contact

Xen Mendelsohn Aderka, VP of Marketing

Xenm(at)Insightec(dot)com

+972-4-8131309

ots Originaltext: InSightec
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