创新焦点：肾去极化（英）2025

EMERGING TECH RESEARCHInnovation Spotlight: Renal Denervation PitchBook Data, Inc. Nizar TarhuniExecutive Vice President ofResearch and Market Intelligence Paul CondraGlobal Head of PrivateMarkets Research James UlanDirector of EmergingTechnology Research Proposed CMS coverage is set to catalyze adoption Institutional Research Group PitchBook is a Morningstar company providing the most comprehensive, mostaccurate, and hard-to-find data for professionals doing business in the private markets. Analysis Aaron DeGagne, CFASenior ResearchAnalyst, Healthcareaaron.degagne@pitchbook.com Innovation overview Data Sara GoodData Analyst Renal denervation (RDN) is emerging as a pivotal innovation in the treatmentof high blood pressure, also known as hypertension. In July, the US Centers forMedicare & Medicaid Services (CMS) proposed national coverage for RDN forcases of uncontrolled high blood pressure—a major milestone for the field. CMSreimbursement would significantly expand patient access to the treatment andlikely lead private insurers to follow suit, positioning RDN for broader adoptionacross both the US and global healthcare systems. pbinstitutionalresearch@pitchbook.com PublishingDesigned byDrew Sanders Published on August 12, 2025 RDN lowers blood pressure by disrupting overactive sympathetic nerves that runalongside the renal arteries, thereby reducing blood flow and lowering blood pressure.This is accomplished via two primary modalities: ultrasound-based renal denervation(uRDN) and radio-frequency-based renal denervation (rfRDN). Two major players leadthe RDN market: Medtronic, which offers an rfRDN system, and Recor Medical, whichhas developed a uRDN platform. Both Medtronic’s Symplicity Spyral system and RecorMedical’s Paradise system received US Food and Drug Administration (FDA) approvalin November 2023, though both devices have been available in Europe—and have hadthe European Conformity (CE) marking—for well over a decade. Contents Innovation overview1Deal activity2Market analysis3Select providers4 Our most recent update on RDN was published in ourQ4 2023 Medtech Report,which followed the FDA approvals for Medtronic and Recor Medical’s RDN systems.Medtronic’s Symplicity Spyral device had already been CE marked and available inEurope, and it was approved in the US despite failing to meet its primary efficacyendpoint in a study released in November 2022, creating skepticism about whetherinsurers would ultimately support coverage for the treatment. However, there hasbeen more positive momentum recently, as both Recor Medical and Medtronic weregranted transitional pass-through (TPT) payment status, which offers temporaryreimbursement to encourage hospital adoption of newly FDA-approved devices.The companies’ TPT payment status began on January 1, 2025, and will run for threeyears, giving both companies a meaningful first-mover advantage. Other notableplayers in the space include DeepQure and Boston Scientific, the latter of whichacquired VC-backed SoniVie for $600 million in March 2025. With efficacy data stillvarying across platforms, multiple device types will likely gain traction in the USmarket, which could exceed $1 billion over the next decade. CMS’s final determination on reimbursement is expected by October 2025. Theproposal, which recommends coverage for both uRDN and rfRDN systems, is openfor a second month-long period of public comment; comments submitted so farby industry stakeholders and providers have been overwhelmingly supportive. Weascribe a high likelihood (above 90%) that CMS will move forward with a positivecoverage decision, considering the current lack of treatment options available foruncontrolled high blood pressure and the high degree of safety for RDN procedures.Still, concerns remain about patient nonresponse to RDN treatment, which isestimated to be as high as 30%.1 Deal activity RDN startups have raised $418.7 million in VC funding since 2015. Annual fundingpeaked at $95.3 million in 2021, aligning with the height of the cycle for VC fundingbroadly. The $418.7 million total includes capital raised by now-acquired startupsSoniVie and Recor Medical, which previously raised about $150 million of fundingcombined. The total amount raised in RDN is a solid level of funding for a marketwith limited penetration and a relatively small number of emerging companies. Weanticipate an uptick in funding and investor interest if CMS decides to cover thetreatment later this year. The largest deals in the RDN space since 2014 have included Ablative Solutions’$91.4 million Series D2 (in 2022); SyMap Medical’s $80 million Series E (in 2021); andSoniVie’s $60 million Series C (in 2023), which preceded its acquisition by BostonScientific. Investor participation has been diverse, which is expected for a nichemarket, though three investors—TechWald Holding, Aphelion Capital, and FairviewHealth Services—have each participated in three separate deals in the sector.Strategic inves