Sonablate announces first patient enrolled in HIFIVE U.S. clinical trial for ablation of incompetent veins

HIFIVE is a single arm, single institution, Phase I trial to assess the safety and performance of Sonablate high-intensity focused ultrasound for treating incompetent veins including vascular malformations

CHARLOTTE, N.C., Oct. 28, 2024 (GLOBE NEWSWIRE) — Sonablate Corp., current makers of the Sonablate HIFU system for prostate tissue ablation, today announced the first patient enrolled in the HIFIVE U.S. clinical trial under principal investigator, Dr. Naiem Nassiri, MD. As part of this new trial, effective HIFU delivery to a symptomatic, incompetent great saphenous vein was safely performed by Dr. Nassiri at The Vascular Care Group in Darien, CT using the Sonablate probe. The clinical trial, which is an FDA-approved, Industry-sponsored Investigational Device Exemption trial (NCT06642051), is being overseen and conducted by Vascular Breakthroughs Research, an affiliate of The Vascular Care Group.

“This is an exciting moment,” said Dr. Nassiri. “High intensity focused ultrasound, or HIFU, has the potential to be a non-invasive treatment option in the specialty of vascular surgery. This is the first, in-human use of the Sonablate probe globally for treating vascular malformations.”

Incompetent veins include refluxing superficial veins of the periphery and include vascular malformations. They impact normal venous flow patterns and can lead to chronic venous insufficiency (CVI), a painful condition that currently affects millions of people in the US and even more globally.

The Sonablate HIFU system is intended to be used in this study to ablate, or eliminate, incompetent veins of the periphery, which includes the legs, abdomen, chest or back. Typically, this condition is treated with invasive techniques such as needle penetration and wire or catheter insertions that require extensive and uncomfortable anesthetic preparations of the targeted vein. But, HIFU is a completely extracorporeal, non-invasive approach, meaning that no part of the treating instrument probe enters the body for delivery of ultrasonic therapeutic energy.

“This achievement represents the culmination of years of research and development,” said Naren Sanghvi, Chief Science Officer of Sonablate. “We are excited to introduce our innovative solutions to the vascular community, empowering these specialists with tools that can lead to faster recovery times and improved patient safety.”

“We are committed to leading the charge in medical innovation,” said Richard Yang, CEO of Sonablate. “We already have years of experience in using HIFU to treat certain conditions of the prostate, and we are excited to continue collaborating with healthcare providers to drive advancements that benefit patients and practitioners alike.”

For more information about Sonablate and its innovative medical technologies, please visit www.sonablate.com.

CONTACT: For additional information or to schedule an interview, please contact Peter Dominick at (408) 368-7366 or email [email protected]