Partner News | Published: Wednesday, April 16, 2025
About the Company
SoniVie, a pioneering medical technology company, has developed the Therapeutic IntraVascular Ultrasound (TIVUS™) System for renal artery nerve denervation using transluminal ultrasound. The TIVUS™ System is a high-intensity, non-focused ultrasound catheter system designed to enable denervation of nerves adjacent to the arterial vessel wall. SoniVie's clinical trial objective was to evaluate the safety and effectiveness of the TIVUS™ System for renal artery denervation
in patients with uncontrolled stage 2 hypertension.
The HeartX Experience
SoniVie and the HealthTech Arkansas Accelerator connected in 2021, before the program rebranded as HeartX. The SoniVie pilot study was a multi-center trial conducted across the U.S. St. Bernards Healthcare (SBHC) and Arkansas Heart Hospitals, two HeartX partner sites, played a valuable role in the study, with Arkansas Heart Hospital enrolling the first U.S. patient on May 5, 2023. By the end of 2023, SoniVie successfully completed enrollment of 25 patients across all trial sites, with the two HeartX-supported sites ranking among the top three enrolling sites.
The impact of the accelerator program extended beyond enrollment. The program’s infrastructure and network facilitated disciplined trial execution across the patient follow-up phase. This success led SoniVie to continue its collaboration with accelerator sites for its subsequent clinical trials, reinforcing the value of the program in advancing innovative cardiovascular solutions.
SoniVie’s groundbreaking work and clinical progress have culminated in the recent agreement to be acquired by Boston Scientific, a global leader in medical technology. This acquisition is a testament to the impact of the TIVUS™ System and the valuable role HeartX played in accelerating SoniVie's journey. By providing the necessary support, infrastructure and access to disciplined trial sites, HeartX contributed to the development pathway for SoniVie, paving the way for this landmark case for acquisition. The partnership between SoniVie and HeartX showcased the program’s effectiveness in propelling pioneering cardiovascular innovations to the forefront of the healthcare industry.
Testimonials
"We look forward to continued success through the HealthTech Arkansas clinical trials. Access to the SoniVie trial provided our hospital and cardiologists the opportunity to be early investigators in the renal denervation arena. We are entering the second phase of the trial now at SBMC. SBMC and our community appreciate the opportunity to provide access to this new technology through clinical trials." - Max Arroyo, MD, Principal Investigator, St. Bernards Healthcare.
"Being part of the SoniVie trial was a great experience. This technology offers a novel way to treat a huge public health problem—hypertension—with better control and less medication. Enrolling the first patient in North America at our hospital, thanks to the HeartX program, was a proud moment. The study saw good clinical success, and I believe this approach has a real opportunity to improve outcomes for a large number of patients. We’re hopeful this will lead to FDA approval and broader adoption in clinical practice.” - Andre Paixao, MD, Principal Investigator, Arkansas Heart Hospital.
About HeartX
HeartX, powered by HealthTech Arkansas and MedAxiom, is a cardiovascular-focused healthcare accelerator that facilitates guaranteed hospital pilot projects and clinical trials for accomplished, early-stage companies bringing new cardiovascular innovations to market. Together, HealthTech Arkansas and MedAxiom use their respective expertise to bring the latest cardiovascular healthcare innovations to the patients who need them most. Learn more.
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