Brazilian Health Regulatory Agency approves MRgFUS for Essential Tremor

Insightec Plans to Expand in Latin America through a partnership with Strattner

HAIFA, Israel and MIAMI, Fl., Feb. 16, 2021 /PRNewswire/ — Insightec®, a global healthcare company focused on creating the next generation of patient care, announced it received market approval by the Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária), and is partnering with Strattner to bring Focused Ultrasound to the Brazilian market.

This approval of the Exablate® 4000 (Exablate Neuro) platform, which uses MR-guided focused ultrasound to precisely ablate tissue deep within the brain without incisions, will enable treatment for Essential Tremor and Tremor-dominant Parkinson’s Disease that has not responded to medications and Neuropathic Pain.

Insightec is working with Strattner, a leading distributor of equipment for minimally invasive and robotic surgery, to reach leading medical centers and help advance adoption of Focused Ultrasound in the Brazilian market.

“Leading neuroscience departments at medical centers around the globe recognize the value of adopting Focused Ultrasound as a treatment option for patient care. We are excited by the opportunities of expansion into Latin America,” commented Maurice R. Ferré MD, Insightec CEO and Chair of the Board of Directors.

Nearly 60 leading medical centers globally treat patients with debilitating hand tremor using Exablate Neuro. Performed in a single session in an MRI suite, many patients experience immediate tremor relief with minimal side effects.

“There are millions of Brazilians suffering from Essential Tremor or Tremor-dominant Parkinson’s Disease and Exablate Neuro Focused Ultrasound has the potential to change their lives, through an incisionless procedure,” said Felipe Strattner, Head of Strategy at Strattner. “We are eager to bring this transformational technology to medical centers across Brazil and help drive medicine forward in our country.”

Exablate Neuro is the first and only focused ultrasound device approved by the U.S. Food and Drug Administration to treat medication-refractory Essential Tremor and Tremor-dominant Parkinson’s Disease.

“Brazil represents a key strategic market in Latin America and this approval strongly positions Focused Ultrasound for future growth in the region,” said J. Michael Quijano, Head of Strategic Partnerships & Business Development, Americas at Insightec.

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 relief to patients with 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.

About Strattner

Strattner has been in the Brazilian medical devices market for 70 years and is responsible for having introduced several groundbreaking technologies into the Brazilian market, in the areas of Surgery, Diagnostic Imaging and Cleaning and Sterilization. Strattner is headquartered in Rio de Janeiro and has commercial offices in 7 additional cities in Brazil.