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

PR71287

HAIFA, Israel, Nov. 29, 2017 /PRNewswire=KYODO JBN/ --

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

SOURCE: INSIGHTEC