Boston Scientific Expands Renal Denervation Portfolio with $540M SoniVie Acquisition

Boston Scientific has announced its acquisition of SoniVie, a renal denervation company, for up to $540 million. This strategic move positions Boston Scientific to compete in the growing hypertension treatment market alongside industry leaders Medtronic and Recor Medical.

Deal Structure and Market Implications

The acquisition involves an upfront payment of approximately $360 million for the remaining 90% stake in SoniVie, with Boston Scientific already owning a 10% equity stake. An additional $180 million is tied to regulatory milestones. The total deal value, including Boston Scientific's current equity ownership, is estimated at around $600 million.

This acquisition is part of Boston Scientific's recent M&A spree, which includes the purchases of Axonics for $3.7 billion, Silk Road Medical for about $1.28 billion, and Bolt Medical for up to $664 million. The deal is expected to close in the first half of 2025, subject to customary closing conditions.

Technology and Clinical Progress

SoniVie's TIVUS system utilizes ultrasound technology for renal denervation, a minimally invasive procedure aimed at treating hypertension by reducing renal nerve activity. The company claims that its ultrasound-based approach allows for deeper tissue penetration and potentially faster procedures compared to radiofrequency alternatives.

A pilot study of 40 participants in the U.S. and Israel demonstrated promising results, with an average 12.0 mmHg reduction in ambulatory systolic blood pressure after three months. Approximately 78% of patients responded to the treatment. SoniVie has recently initiated a global, sham-controlled pivotal trial to support FDA approval, with plans to follow patients for at least six months.

Competitive Landscape and Market Potential

The renal denervation market is poised for significant growth, with Medtronic estimating that 1% market penetration could equate to about $1 billion in revenue. Both Medtronic and Recor Medical received FDA approvals for their renal denervation systems in November 2023, with Medicare granting temporary reimbursement at the beginning of this year.

The Centers for Medicare and Medicaid Services (CMS) began a national Medicare coverage analysis for renal denervation in January, with a decision expected by mid-October. This potential expansion of Medicare coverage could serve as a catalyst for market growth.

Lance Bates, Boston Scientific's president of interventional cardiology therapies, emphasized the significance of this acquisition, stating, "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."