Sonablate Opens Phase 1 Trial of HIFU Ablation of Incompetent Veins

October 21, 2024—Sonablate Corp. announced the first patient was enrolled in the phase 1 HIFIVE United States clinical trial of the Sonablate high-intensity focused ultrasound (HIFU) system for treating incompetent veins of the periphery, including vascular malformations, with a completely extracorporeal, noninvasive approach.

Currently, the Sonablate HIFU device is used commercially for prostate tissue ablation with 510(K) clearance in the United States, CE Mark approval in Europe, and NMPA clearance in China, as well as regulatory authorization in more than 50 additional countries, advised the company.

According to Sonablate, the company-sponsored, single-center HIFIVE trial is being conducted under an FDA-approved investigational device exemption. The trial is overseen and conducted by the Vascular Breakthroughs Research, an affiliate of The Vascular Care Group. The principal investigator is Naiem Nassiri, MD, a vascular surgeon with The Vascular Care Group in Darien, Connecticut.

Dr. Nassiri enrolled the first patient in the trial. He safely performed a HIFU delivery to a symptomatic, incompetent great saphenous vein using the Sonablate probe, reported the company.

“This is an exciting moment,” commented Dr. Nassiri in the company’s press release. “High-intensity focused ultrasound, or HIFU, has the potential to provide many benefits within the specialty of vascular surgery, and I’m proud to have foreseen and implemented this technology for an extracorporeal means of treating incompetent veins of the periphery.”

Dr. Nassiri continued, “This is the first-in-human use of the Sonablate probe for this application and will be the first such application globally using this platform for treating vascular malformations.”