J&J’s $1.7 billion bet on Israeli heart device falters after FDA panel vote
Advisors reject effectiveness of V-Wave’s implant, threatening the contingent value of last year’s acquisition.
When Johnson & Johnson acquired Israeli heart-device maker V-Wave in 2024, the structure of the deal made clear where the true value lay. Just $600 million was paid upfront. The remaining $1.1 billion, two-thirds of the potential $1.7 billion payout, depended entirely on the device clearing regulatory and commercial milestones, the most central of which was securing U.S. Food and Drug Administration approval.
That milestone now appears increasingly out of reach.
A U.S. Food & Drug Administration advisory panel voted unanimously last week that the benefits of V-Wave’s Ventura Interatrial Shunt System do not outweigh its risks, a pointed rebuke for a device that once held the FDA’s breakthrough designation and was championed as a first-in-class solution for heart failure. Panelists also voted unanimously that there was no “reasonable assurance” the device is effective, undercutting the clinical foundation of the acquisition itself.
The vote followed a detailed review of RELIEVE-HF, a randomized trial of more than 500 patients. While the implant met its primary safety endpoint, the effectiveness data fractured sharply across patient groups: patients with reduced ejection fraction (HFrEF) showed improvement, while those with preserved ejection fraction (HFpEF) experienced worse outcomes.
The panel’s conclusion, unanimous on risk-benefit and on lack of demonstrated effectiveness, shifts the trajectory of the V-Wave acquisition from high-stakes bet to uncertain path.
“The signal is favorable, but we still need more data,” panelist Amit Shanker, MD, said, noting the study’s limited statistical power for subgroup conclusions.
The FDA typically follows its advisory panels’ recommendations, and while approval technically remains possible, the likely scenarios are narrowing. If the agency approves the device at all, panelists said, it would be restricted to the HFrEF population, excluding the broader market for which V-Wave’s technology was designed. If not approved, the company may be asked to run a larger randomized trial, an undertaking that would delay commercialization for years.
Either outcome directly affects the acquisition’s economics.
The 2024 deal, announced as part of Johnson & Johnson’s broader push to replace revenue that will be lost when its blockbuster drug Stelara faces increased competition, was billed at “up to $1.7 billion.” But that valuation was always conditional. Without FDA clearance, the bulk of the contingent $1.1 billion will almost certainly not be paid, effectively freezing the deal at its $600 million base price.
