India Ministry of Health and Family Welfare Approves Exablate Neuro Focused Ultrasound Platform
PR91753
HAIFA, Israel and MIAMI, Fla., Sept. 20, 2021 /PRNewswire=KYODO JBN/ --
Insightec(R) [ http://www.insightec.com/ ] , a global healthcare company
focused on transforming patient care, announced its incisionless neurosurgery
platform, the Exablate(R) 4000, has received market approval by the Central
Drugs Standard Control Organization (CDSCO), part of the Ministry of Health and
Family Welfare of India.
The Exablate 4000 (Exablate Neuro) platform uses MR-guided focused ultrasound
to precisely ablate a small target deep within the brain without incisions. The
approval will enable treatment of patients in India living with Essential
Tremor, Tremor-dominant Parkinson's Disease and Neuropathic Pain.
"This approval adds to the growing recognition of the value of Focused
Ultrasound for global healthcare systems," commented Maurice R. Ferre MD,
Insightec CEO and Chairman of the Board of Directors. "More importantly,
expanded access to our technology is helping to transform the lives of people
living with debilitating medical conditions."
Essential Tremor is a neurological condition that causes uncontrollable shaking
in an estimated 41 million people worldwide. More than 80 medical centers
around the globe are treating Essential Tremor patients with the Exablate Neuro
on a regular basis. Performed in a single session in an MRI suite, many
patients experience immediate tremor relief in the treated hand with minimal
side effects.
"This technology offers appropriate patients immediate tremor control with a
less invasive procedure that requires no incisions or anesthesia with minimal
complications," said Prof. Paresh Doshi, Director of Neurosurgery at Jaslok
Hospital and Research Centre and Group Advisor Functional Neurosurgery, Apollo
Group of Hospitals, President of The Neuromodulation Society of India and Past
President of the Indian Society for Stereotactic and Functional Neurosurgery.
"Global clinical studies have demonstrated the procedure as approved is safe
and helps patients to regain daily function."
About Insightec
Insightec is a global healthcare company creating the next generation of
patient care by realizing the therapeutic power of acoustic energy. The
company's Exablate Neuro platform focuses sound waves, safely guided by MRI, to
provide tremor treatment to patients with medication-refractory Essential
Tremor and Tremor-dominant Parkinson's Disease. Research for future
applications in the neuroscience space is underway in partnership with leading
academic and medical institutions. Insightec is headquartered in Haifa, Israel,
and Miami, with offices in Dallas, Shanghai and Tokyo.
Follow us on Facebook [ https://www.facebook.com/INSIGHTEC.MRgFUS/ ], LinkedIn
[ https://www.linkedin.com/company/insightec/ ] and Twitter [
https://twitter.com/INSIGHTEC ] or visit www.insightec.com for more information.
Forward-looking Statements
This document contains forward-looking statements regarding, among other
things, plans, expectations, and future events. In some cases, forward-looking
statements can be identified by the following words: "may," "can," "will,"
"could," "would," "should," "expect," "intend," "plan," "anticipate,"
"believe," "estimate," "predict," "project," "potential," "promise,"
"continue," "ongoing," or the negative of these terms. Forward-looking
statements involve known and unknown risks, uncertainties and other important
factors that could cause actual results to differ materially from what is
expressed or implied by the statements. Any forward-looking statement is based
on information available to Insightec as of the date of the statement. All
written or oral forward-looking statements attributable to Insightec are
qualified by this caution. Insightec does not undertake any obligation to
update or revise any forward-looking statement to reflect any change in
circumstances or in Insightec's expectations.
"Exablate," and "Exablate Neuro," as well as the "INSIGHTEC" logo, whether
standing alone or in connection with the word " Insightec", are protected
trademarks of Insightec.
Insightec Media Contact
G&S Business Communications for Insightec
Elizabeth Mannheimer
+1 917.595.3034
emannheimer@gscommunications.com
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Source: Insightec
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