Insightec’s Exablate wins CE Mark approval for prostate treatment, Japanese approval for essential tremor

Insightec this week announced 2 regulatory wins, receiving CE Mark approval in the European Union for its Exablate Prostate for treating locally-confined prostate cancer and Japanese approval for its Exablate Neuro for treating essential tremor.

The Exablate Prostate system uses focused ultrasound to target and ablate tissue in the prostate while minimizing damage to adjacent structures, the company said.

“Focused ultrasound treatment for prostate cancer may offer a novel method to re-think the management of locally-confined prostate cancer in select patients. MR imaging allows real-time visualization and temperature feedback to surgeons to allow for precision in tissue ablation and preservation of healthy tissue,” Dr. Behfar Ehdaie of Memorial Sloan Kettering Cancer Center said in a press release.

Insightec said that treatment with the Exablate Prostate requires no incisions, is performed in a single session and allows patients to return to normal activity normal than invasive procedures.

“Insightec has reached another important strategic milestone. We remain focused on expanding the Exablate technology platform to address multiple clinical indications and treat more patients worldwide,” CEO & board chair Dr. Maurice Ferré said in a prepared release.

The company won Japanese Ministry of Health, Labor and Welfare approval for its Exablate Neuro system, now indicated for the non-invasive treatment of essential tremor in patients who’ve not responded to medication.

“Results of this study show that Exablate Neuro is safe and effective for treating essential tremor. Finding the most effective way to manage tremor symptoms and improve the quality of life is crucial for patients. Patients treated showed immediate tremor control, allowing them to regain ability to perform daily tasks such as eating and writing,” Dr.  Takaomi Taira of Tokyo Women’s Medical University said in prepared remarks.

The Exablate Neuro system is designed to be performed under Magnetic Resonance Imaging guidance, and uses focused ultrasound waves to target and ablate tissue deep within the brain.

“Insightec is committed to the Japanese neurosurgery market. Following the MHLW approval, Insightec Japan can develop its market presence and offer essential tremor patients a non-invasive solution to improve their quality of life,” Insightec Japan country manager Yair Bauer said in a prepared statement.

Approval was granted based on data from a randomized, double-blinded clinical study conducted at 8 medical centers in North America and Asia which demonstrated safety and efficacy of the system.

In August, Insightec released results from a pivotal study of its Exablate Neuro system which met its primary endpoint with patients treated with the system reporting a 47% improvement in a composite tremor score at 3 months. Data from the study were published today in the New England Journal of Medicine.

The 76-patient study looked to evaluate the safety and efficacy of the device to treat essential tremor in patients who were unresponsive to medication, and data from the study was submitted to the FDA as the company seeks approval. If won, the approval would the the 1st for a focused ultrasound device designed to treat essential tremor.

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