FDA clears Insightec's MRI-guided sound wave technology to treat prostate cancer

MRI machine in a hospital
The Exablate Prostate system, guided by MRI technology, directs sound waves toward cancerous prostate tissue, destroying only the malignant tissue and preserving the healthy structures nearby. (nimon/Shutterstock)

While Insightec has raked in hundreds of millions of dollars in VC funding in recent years based largely on the strength of its Exablate Neuro platform, the company continues to expand its focused ultrasound technology beyond the brain.

Most recently, it landed 510(k) clearance from the FDA for Exablate Prostate, which uses Insightec’s signature targeted sound wave tech to destroy cancerous prostate tissue in low- or intermediate-risk patients.

The system directs high-intensity focused ultrasound waves toward the specified tissue, guided throughout the process by an MRI machine for help with both navigating through the patient’s anatomy and monitoring the tissue’s temperature in real-time. Exablate Prostate is designed to destroy only the targeted tissue, preserving the surrounding healthy structures.

Additionally, the acoustic ablation technique requires no incisions and can be performed in a single session, slashing the lengthy recovery time typically required after more invasive cancer treatments.

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In a trial sponsored by Insightec, Exablate Prostate was proven to cause only minimal damage to the healthy tissue surrounding cancerous prostate tissue. It also had low impacts on the patients’ post-op potency and continence.

“Exablate focused ultrasound has been shown to provide effective control of locally confined prostate cancer in select patients based on two-year biopsy outcomes,” Behfar Ehdaie, M.D., primary investigator of the study and a urologic surgeon at Memorial Sloan Kettering Cancer Center, said in a statement.

“Precision ablation, together with MR imaging and thermal feedback, may enable men to consider a tissue-preserving approach and defer or avoid radical therapy,” Ehdaie continued.

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The prostate cancer-focused technology’s FDA clearance comes just a month after Insightec racked up yet another regulatory approval for its Exablate Neuro system. The new indication allows the brain-centric version of the focused ultrasound tech to be used to treat patients with advanced Parkinson’s disease who are experiencing issues with mobility, rigidity and dyskinesia, a complication that causes involuntary muscle movements.

That FDA approval adds to Exablate Neuro’s other indications, which OK the system for use in treating tremors in patients with tremor-dominant Parkinson’s or medication-resistant essential tremor.

Though Exablate Neuro has become Insightec’s flagship product since its first FDA nod in 2016, Exablate Prostate marks a return to the Israeli company’s original focus outside the brain. Dating back to 2004, Insightec initially locked down the agency’s approval to apply its Exablate tech toward the treatment of uterine fibroids and metastatic bone cancer pains.