Boston Scientific is diving into the field of renal denervation, with a $540 million deal for SoniVie and its ultrasound-based therapy for stubbornly high blood pressure.
The acquisition sets up the company to potentially compete against Medtronic and Recor Medical—whose respective FDA-approved procedures received temporary reimbursements from Medicare at the top of this year while the government payer considers establishing national coverage, with a decision expected by mid-October.
Boston Scientific previously purchased a 10% stake in SoniVie, as the Israel- and Minnesota-based company works to develop its TIVUS system.
Its minimally invasive catheter is designed to reach the arteries feeding the kidney and isolate any of the surrounding, overactive nerves that may be driving hypertension, especially in patients that have not seen success with multiple blood pressure medications.
“Renal denervation for hypertension is an exciting medical advancement for the millions of patients it may help and is supported by positive results from contemporary clinical trials and ongoing research,” Lance Bates, Boston Scientific’s president of interventional cardiology therapies, said in a statement.
“We believe the addition of the differentiated, ultrasound-based TIVUS system can complement our expansive interventional portfolio with a minimally invasive therapy for patients with hypertension and provides opportunity for future advancements in this space,” Bates added.
The companies expect the buyout to close before the end of June, with a $360 million upfront payment for the 90% remaining stake, plus up to an additional $180 million tied to TIVUS clearing regulatory milestones. Including its current equity ownership, Boston Scientific estimates the total deal value to be around $600 million.
Last year, SoniVie put forward a pilot study of 40 participants in the U.S. and Israel, showing an average 12.0 mmHg reduction in ambulatory systolic blood pressure after three months, with about 78% of patients responding to the treatment.
A global, sham-controlled pivotal trial, aimed at obtaining FDA approval, was recently launched as well, and plans to follow patients for at least six months.
The company said its approach differs from Medtronic’s radiofrequency- and Recor’s ultrasound-powered devices in that TIVUS does not need to be in anchored contact with the vessel wall, which allows the flow of blood to cool down the heat generated by the catheter.
Medtronic’s Symplicity Spyral platform previously demonstrated a 18.7 mmHg drop in 24-hour systolic blood pressure three years after the one-time procedure. Meanwhile, a study from Recor, a division of the Tokyo-based Otsuka Medical Devices, showed its Paradise system could cut systolic BP by about 8 mmHg after two months.
Both companies’ approaches were approved by the FDA in November 2023.