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COMPANY

Paragonix Technologies

paragonixtechnologies.com ↗

FDA-cleared device company

Profile checked Oct 10, 2026

Keywords: Pancreas (Including SPK) Transplantation Pancreas Diseases Pancreas Transplant Rejection Interstitial Lung Disease COPD Cystic Fibrosis Pulmonary Fibrosis Pulmonary Arterial Hypertension Emphysema Liver Diseases Liver Dysfunction Liver Transplant Disorder Liver Transplant Rejection Lung Transplant Rejection Heart Diseases Heart Failure Congenital Heart Defects PancreasPak LIVERguard SherpaPak Cardiac Transport System

5Trials (company is sponsor)2FDA records (2 yrs)

Timeline

  1. Trial start —: Global Utilization And Registry Database for Improved preservAtion of doNor Pancreata (GUARDIAN-PANCREAS) source ↗
  2. FDA FDA 510(k) clearance: BAROguard Donor Lung Preservation System — K254305, Jan 30, 2026. Applicant at approval: Paragonix Technologies, Inc. source ↗
  3. FDA FDA 510(k) clearance: KIDNEYvault Portable Renal Perfusion System — K234060, Oct 23, 2024. Applicant at approval: Paragonix Technologies. source ↗
  4. Trial start —: Analysis of Volatile Organic Compounds in the Breath of Lung Transplant Rejection Patients Using Infrared Spectroscopy source ↗
  5. Trial start —: Global Utilization And Registry Database for Improved preservAtion of doNor Livers source ↗
  6. Trial start —: Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs source ↗
  7. Trial start —: Global Utilization And Registry Database for Improved heArt preservatioN source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 5

RecordTitlePhaseStatusStartPrimary completion
NCT07487194Global Utilization And Registry Database for Improved preservAtion of doNor Pancreata (GUARDIAN-PANCREAS)Not listedNot yet recruiting2027-012031-06 (estimated)
NCT04930289Global Utilization And Registry Database for Improved preservAtion of doNor LUNGsNot listedEnrolling by invitationOct 15, 2021Jun 15, 2028 (estimated)
NCT05082077Global Utilization And Registry Database for Improved preservAtion of doNor LiversNot listedEnrolling by invitationMar 15, 20222027-08 (estimated)
NCT06309628Analysis of Volatile Organic Compounds in the Breath of Lung Transplant Rejection Patients Using Infrared SpectroscopyNot listedTerminatedSep 21, 2023May 9, 2025 (actual)
NCT04141605Global Utilization And Registry Database for Improved heArt preservatioNNot listedEnrolling by invitationFeb 14, 2020Dec 31, 2027 (estimated)

FDA records (last 2 years)

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LinkedIn page linked from the company's own site: source · seen 2026-10-12

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