SoniVie is an Israeli medical device company developing the TIVUS™ (Therapeutic Intra-Vascular Ultrasound) System, a catheter-based technology for nerve denervation to treat hypertensive disorders, primarily renal artery denervation (RDN) for uncontrolled hypertension and previously pulmonary arterial hypertension (PAH).[1][2][5] The system uses high-frequency, non-focused ultrasound energy delivered through blood vessels without anchoring to artery walls, enabling continual blood flow for cooling while ablating perivascular nerves to reduce sympathetic nerve activity, relax blood vessels, and lower blood pressure.[2][5][6] It serves patients with drug-resistant hypertension—affecting millions globally—addressing unmet needs where medications fail, with early clinical data showing blood pressure reductions and three FDA Breakthrough Device Designations.[1][5][7] Growth momentum includes completed enrollment in the U.S./Israel REDUCED-1 IDE pilot trial (40 patients), initiation of the global THRIVE IDE pivotal trial, and a March 2025 acquisition agreement by Boston Scientific for $360M upfront (90% stake) plus up to $180M in milestones, validating its potential.[2][4][5][7]
Founded in 2014 in Rosh HaAyin, Israel (with a Boston office), SoniVie emerged from Cardiosonic's foundational TIVUS technology for RDN in hypertension treatment.[1][5] The idea built on ultrasound-based nerve ablation to target overactive renal nerves driving high blood pressure, expanding from PAH (first-in-human trials showing strong results) to broader pulmonary hypertension and now renal applications.[1][5] Pivotal early moments include 2019 FDA Breakthrough Designation for PAH, positive 2023-2024 IDE pilot data, and Boston Scientific's strategic 10% equity investment, culminating in the 2025 acquisition deal amid surging RDN market interest post-competitor approvals.[1][2][5][7]
SoniVie rides the renal denervation renaissance, ignited by 2023 FDA approvals for ReCor's Paradise (ultrasound) and Medtronic's Symplicity Spyral (radiofrequency), addressing a massive unmet need in drug-resistant hypertension affecting millions.[2][7] Timing aligns with clinical trial successes proving durable blood pressure reductions via nerve ablation, amid rising cardiovascular disease burdens and demand for minimally invasive alternatives to lifelong meds.[7] Market forces favor it: FDA Breakthrough status speeds paths to approval/reimbursement; Boston Scientific's acquisition (as a prior investor) accelerates commercialization and expands to hypertensive disorders beyond kidneys.[2][5] SoniVie influences medtech by validating intravascular ultrasound for sympathectomy, potentially inspiring expansions in pulmonary/heart failure therapies and intensifying competition in a burgeoning RDN sector.[1][5]
Post-acquisition, SoniVie integrates into Boston Scientific's interventional cardiology portfolio, prioritizing THRIVE pivotal trial completion for FDA approval—likely 2026-2027 given momentum and Breakthrough status.[2][5] Rising hypertension prevalence, RDN evidence buildup, and ultrasound's edge in safety/depth will shape success, with radial access enabling broader adoption.[5][7] Its influence evolves from scrappy innovator to scaled therapy, potentially transforming millions' access to nerve modulation while eyeing PAH revival—cementing TIVUS as a hypertension game-changer from Israel's medtech hub.[1][2]
SoniVie has raised $60.0M in total across 1 funding round.
SoniVie's investors include Andera Partners, OrbiMed.
SoniVie has raised $60.0M across 1 funding round. Most recently, it raised $60.0M Series C in January 2023.
| Date | Round | Lead Investors | Other Investors |
|---|---|---|---|
| Jan 1, 2023 | $60.0M Series C | Andera Partners, OrbiMed |
