Insightec Receives IDE Approval for Study of Exablate Prostate System’s High-Intensity Focused Ultrasound Technology

June 30, 2022—Insightec announced that it has received FDA approval for an investigational device exemption for a clinical comparative study of the company’s Exablate Prostate system used to treat diseased prostate tissue. The study will evaluate the safety and efficacy of focal treatment using high-intensity focused ultrasound when compared to active surveillance in men with prostate cancer.

The study’s Principal Investigator is Behfar Ehdaie, MD, a urologic surgeon at Memorial Sloan Kettering Cancer Center in New York, New York.

“We are excited to continue this important research that can impact the standard of care for prostate cancer treatment,” commented Dr. Ehdaie in the company’s press release. “Exablate focused ultrasound has been shown to provide an accurate, safe, and effective option to engage the prostate gland directly in select patients based on 2-year biopsy outcomes. The new trial will build on this success and help further enhance treatment options.”

The company noted that a previous Insightec-sponsored clinical trial led by Memorial Sloan Kettering Cancer Center for the Exablate Prostate system reported minimal damage to adjacent structures and low rates of impact on potency and continence, supporting function and quality of life for patients. The new comparative study builds on the evidence of this clinical trial and aims to further enhance prostate treatment options and improve clinical outcomes.

Results from the new study will define the role of focal therapy to delay and avoid radical therapy for men with prostate cancer and support expanded clinical adoption of the technology and increased access for patients through insurance reimbursement, advised the company.

According to the company, the Insightec Exablate Prostate system uses sound waves to ablate targeted tissue in the prostate. The treatment is performed under MRI guidance for high-resolution visualization of the patient’s anatomy for precise targeting and real-time temperature monitoring. The single-session treatment does not require incisions and allows patients to quickly return to normal activity with minimal complications.

Insightec announced FDA 510(k) clearance for the Exablate Prostate on December 1, 2021, and announced the first commercial patient treatment with the device on February 3, 2022.