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Key Points The Sonablate high-intensity focused ultrasound (HIFU) system is being tested for this new indication.  Vascular surgeon Naiem Nassiri, MD, will enroll 30 participants in the clinical trial.  The first participant has been treated in a clinical trial assessing the safety of using high-intensity focused ultrasound (HIFU) to treat patients with incompetent veins of the extremities, including vascular malformations.  Incompetent veins – including vascular malformations – involve abnormal flow patterns that can lead to venous insufficiency, a painful condition that affects millions of people in the US. The clinical trial seeks to address deep and superficial venous reflux, varicose veins, venous ulcers, and vascular malformations.    Up to 30 participants with incompetent veins of the extremities will be treated with the Sonablate HIFU system to noninvasively ablate culprit incompetent veins. The Sonablate HIFU system uses extracorporeal imaging to localize and aim the Sonablate HIFU probe. This FDA-approved Investigational Device Exemption (IDE) clinical trial, called HIFIVE (High-Intensity Focused ultrasound for treatment of Incompetent Veins of the Extremity), is led by Naiem Nassiri, MD, a vascular surgeon with The Vascular Care Group (TVCG) in Darien, Connecticut.    Dr.  Nassiri and his research Team from The Vascular Breakthroughs, LLC will monitor participants at regular intervals up to 30 days to primarily assess safety of the device, and to secondarily assess for device efficacy in ablating or destroying diseased, incompetent veins.    “This achievement represents the culmination of years of research and development initiated by Dr. Nassiri and Sonablate Corp.,” said Naren Sanghvi, Sonablate’s Chief Scientific Officer. “We are excited to introduce Dr. Nassiri’s innovative solutions to the vascular community, empowering this specialty that can lead to faster recovery times and improved patient safety utilizing the Sonablate image guided HIFU.”  This is the first time that the Sonablate HIFU device is being used to treat vascular disease in humans, but it has had a long history of addressing other diseases. In 2015, it was the first focused ultrasound device to be FDA-cleared in the US for the ablation of prostate tissue, meaning the technology could be used to treat conditions like prostate cancer and benign prostatic hypertrophy. Today, the device is approved for those conditions in more than 50 countries worldwide and has treated thousands of patients with prostate cancer.  For Patients  To learn more about the CVI clinical trial, please visit the clinical trial website or contact the clinical research nurse coordinator at (203) 548-7860, ext. 998, or email mmyslinski@vascularbreakthroughs.com.  Read Sonablate’s Press Release  

Key Points SONIRE Therapeutics’ focused ultrasound system uses cavitation bubbles that increase the heating efficiency and visualization in treating pancreatic cancer. The FDA’s Breakthrough Devices Program allows fast-tracking of certain novel devices and expedites patient access to treatments.   Focused Ultrasound company SONIRE Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its next-generation high-intensity focused ultrasound (HIFU) therapy system (development code : Suizenji) for the treatment of pancreatic cancer.   Pancreatic cancer is notoriously challenging to treat, and, according to the National Cancer Institute, the five-year survival rate is only about 12%.   SONIRE’s Suizenji system was developed based on a device used in a clinical study for pancreatic cancer in Japan in 2017. It uses cavitation bubbles that increase the heating efficiency, enabling effective thermal therapy with lower acoustic energy. The bubbles also aid in visualizing the treatment area on ultrasound imaging.  Last year, the company launched a multicenter, randomized clinical trial for unresectable pancreatic cancer in Japan. The trial is assessing whether participants who receive HIFU therapy in addition to chemotherapy experience prolonged survival when compared with participants who receive chemotherapy alone.   The Breakthrough Devices Program was established by the FDA in 2018 to fast-track novel devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.  “The program offers device manufacturers an opportunity to work directly with the FDA through the premarket review stage of the approval process,” explains Jessica Foley, PhD, the Foundation’s chief scientific officer and managing director of government affairs. “The goal is to expedite patient access to devices that provide more effective treatment or diagnosis, through a more rapid assessment and review process, while preserving the FDA’s standards of approval.”  Five other focused ultrasound companies have earned Breakthrough Device Designation for their products: HistoSonics for its EdisonTM histotripsy platform, Acoustiic  for its ultrasound arrays, Carthera for its SonoCloud-9 device for glioblastoma, Cordance Medical for its NeuroAccess liquid biopsy device, and EDAP TMS for its Focal One platform.   Read SONIRE’s Press Release  Learn more about SONIRE  

Videos of the presentations, which feature featuring leading urologists and industry representatives, are now available.

ARPA-H was established only a couple of years ago, in May 2022, but its impact on healthcare research and industry has already been notable. We encourage the entire focused ultrasound community to explore how their projects and companies could benefit from ARPA-H funding. Read on for answers to frequently asked questions that the FUS Partners team has fielded from the community.