Parkinson’s Disease is expected to affect more than 1.2 million Americans by 2030. While medications remain the primary way to treat patients, many of them eventually experience side effects or diminishing effectiveness, prompting the need for more options.
Insightec, the Miami-based innovator in focused ultrasound to transform patient care, announced July 8 the U.S. Food and Drug Administration approved the use of its Exablate Neuro platform for staged bilateral pallidothalamic tractotomy treatment in patients living with advanced Parkinson’s disease.
Exablate Neuro uses focused ultrasound, technology that Insightec pioneered in Israel, to precisely treat targeted areas in the pallidothalamic tract, guided by MRI. The procedure is incisionless and does not require implanted hardware. This new indication covers both the initial and the subsequent staged procedure, enabling comprehensive bilateral treatment and expanding therapeutic options for Parkinson’s patients suffering from severe motor symptoms such as rigidity, bradykinesia, and dyskinesia who haven’t found relief from medication, the company said in its announcement of the approval.
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“With this new indication, we’re advancing care for movement disorders and opening the door to life-changing treatment for those who need it now and in the years ahead,” said Maurice R. Ferré, CEO and chairman of Insightec and a serial medtech entrepreneur who previously co-founded Mako Surgical, a robotic surgery company acquired by Stryker for $1.6 billion in 2013.
Insightec plans to offer the bilateral procedure in select centers during 2025, as it continues to work on making the reimbursement process easier and the procedure available to more people.
“This milestone reflects our commitment to expanding access to safe, effective, and incisionless treatment options for people living with Parkinson’s disease,” said Ferre.
The Exablate Neuro platform previously received FDA approval for several other indications for essential tremor and/or Parkinson’s. So far, more than 25,000 patients have been treated with Insightec’s Exablate technology for a variety of movement disorder indications at 197 centers worldwide, including 84 in the United States. In the future, the technology could be used to treat Alzheimer’s and other diseases of the brain.
Insightec was founded in Israel in 1999. Ferré was named Insightec CEO in 2016 and has always run the company from Miami. Ferré is also a founding board member of Endeavor Miami, co-founder of Miami-based DermaSensor, and has been a leader in efforts to grow Miami’s strength in medtech, one of South Florida’s strongest tech sectors.
A year ago, Insightec raised $150 million in an equity round led by Fidelity Management. The company has secured more than $800 million in equity and debt financing since its founding.
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This story was originally published by Refresh Miami, a WLRN News partner. Refresh Miami is the oldest and largest tech and startup community in Miami with over 16,000 members.
This was shown first on: https://www.wlrn.org/health/2025-08-01/miami-based-company-receives-fda-approval-of-parkinsons-treatment
