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COMPANY

JenaValve

HQ: Irvine, CA source · jenavalve.com ↗

FDA-cleared device company

Location: Irvine, CA · source · Oct 15, 2026

Profile checked Oct 10, 2026

Keywords: Aortic Regurgitation Aortic Valve Insufficiency Aortic Insufficiency Aortic Valve Stenosis Aortic Valve Disease Heart Valve Diseases Ventricular Outflow Obstruction Heart Diseases Cardiovascular Diseases Aortic Valve Regurgitation Aortic Valve Stenosis With Insufficiency Pathologic Constriction Cardiovascular Diseases in Old Age Severe Aortic Stenosis Left Ventricular Dysfunction Aortic Stenosis JenaValve Pericardial TAVR System JenaValve Trilogy Heart Valve System Transcatheter Aortic Valve Implantation Transcatheter aortic valve replacement

8Trials (company is sponsor)1FDA records (2 yrs)

Timeline

  1. FDA FDA PMA approval: Trilogy Transcatheter Heart Valve System — P250024, Mar 17, 2026. Applicant at approval: JenaValve Technology, Inc. source ↗
  2. Trial start Not phased (device or behavioral study): ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™ source ↗
  3. Trial start Not phased (device or behavioral study): The JenaValve ALIGN-AR LVAD Registry source ↗
  4. Trial start —: TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease source ↗
  5. Trial start Not phased (device or behavioral study): The JenaValve ALIGN-AR Pivotal Trial source ↗
  6. Trial start Not phased (device or behavioral study): THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study source ↗
  7. Trial start Not phased (device or behavioral study): JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study source ↗
  8. Trial start Not phased (device or behavioral study): First in Man Study of the JenaValve TAVI Plus System Transfemoral source ↗
  9. Trial start —: JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 8

RecordTitlePhaseStatusStartPrimary completion
NCT06608823ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™Not phased (device or behavioral study)RecruitingJun 18, 20252027-06 (estimated)
NCT05536310TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve DiseaseNot listedTerminatedAug 1, 2023Jul 9, 2024 (actual)
NCT06594705The JenaValve ALIGN-AR LVAD RegistryNot phased (device or behavioral study)Active, not recruitingDec 9, 20242026-08 (estimated)
NCT02732691JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis StudyNot phased (device or behavioral study)Unknown status (ClinicalTrials.gov)Oct 21, 2016May 28, 2019 (actual)
NCT02732704THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation StudyNot phased (device or behavioral study)Active, not recruitingApr 20, 2018Aug 29, 2022 (actual)
NCT04415047The JenaValve ALIGN-AR Pivotal TrialNot phased (device or behavioral study)Active, not recruitingMay 22, 2020Aug 29, 2023 (estimated)
NCT01598844JUPITER Study: Transapical Aortic Valve Implantation for Aortic RegurgitationNot listedCompletedMay 30, 2012Aug 27, 2015 (actual)
NCT02818959First in Man Study of the JenaValve TAVI Plus System TransfemoralNot phased (device or behavioral study)Terminated2013-122014-03 (actual)

FDA records (last 2 years)

Raises and investors new

Form D raises come from the company’s own SEC filing (last 2 years).

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