TransMedics Group, Inc. (TMDX)
TransMedics Group, Inc. operates as a commercial-stage medical technology enterprise, committed to transforming the landscape of organ transplant therapy for patients worldwide grappling with end-stage organ failure. At the core of their offerings is the Organ Care System (OCS), an innovative, portable solution engineered to perfuse, optimize, and continuously monitor donor organs. This system leverages exclusive, tailored technology to meticulously recreate near-physiological conditions for these vital organs while they remain outside the human body. The OCS suite encompasses specialized modules: OCS LUNG, which facilitates the preservation of standard criteria donor lungs for double-lung transplants; OCS Heart, designed for the extracorporeal perfusion and maintenance of donor hearts; and OCS Liver, dedicated to the preservation of donor livers. Founded in 1998, TransMedics is headquartered in Andover, Massachusetts.
Sector: Electromedical & Electrotherapeutic Apparatus
Industry: Medical - Devices
TransMedics Group, Inc.
Trials need funding. See this company's dilution risk and cash position.
- Not applicableCompleted
Randomized Study of Organ Care System Cardiac for Preservation of Donated Hearts for Eventual Transplantation
Organ Care System, Cold Cardioplegia Solution
Heart Failure
NCT00855712Enrollment128StartMar 2009Primary CompletionOct 2013CompletionNov 2013 - Not applicableCompleted
International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation
OCS Lung, Cold flush and storage
Lung Preservation
NCT01630434Enrollment320StartNov 2011Primary CompletionSep 2014CompletionApr 2016 - Not applicableCompleted
International EXPAND Lung Pivotal Trial
OCS Lung Preservation
Lung Transplant
NCT01963780Enrollment79StartNov 2013Primary CompletionNov 2016CompletionApr 2018 - Not applicableCompleted
International EXPAND Heart Pivotal Trial
Preservation of Hearts for Transplantation
Heart Transplant
NCT02323321Enrollment75StartSep 2015Primary CompletionApr 2018CompletionMar 2019 - Not applicableCompleted
Trial of the TransMedics Organ Care System™ Liver For Preserving and Assessing Donor Livers for Transplantation
OCS Liver
Liver Preservation
NCT02449694Enrollment25StartMay 2016Primary CompletionSep 2017CompletionJan 2018 - Not applicableCompleted
OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation
OCS™ Liver System, Control
Liver Transplantation, Liver Preservation for Transplant
NCT02522871Enrollment300StartJan 2016Primary CompletionOct 2019CompletionNov 2021 - Not applicableTerminated
OCS Lung System EXPAND II Trial
OCS Lung Preservation
Lung Transplantation
NCT03343535Enrollment46StartMar 2018Primary CompletionAug 2019CompletionJul 2022 - ObservationalActive, not recruiting
OCS™ Lung TOP Registry For Donor Lungs for Transplantation
OCS Lung System
Lung Transplantation
NCT03639025Enrollment458StartDec 2018Primary CompletionNov 2025est.CompletionNov 2029est. - Not applicableCompleted
Donors After Circulatory Death Heart Trial
OCS Heart System, Cold Storage
Heart Transplant
NCT03831048Enrollment180StartNov 2019Primary CompletionApr 2021CompletionSep 2021 - Not applicableCompleted
Heart EXPAND Continued Access Protocol
OCS Heart System
Heart Transplant
NCT03835754Enrollment75StartApr 2019Primary CompletionSep 2021CompletionAug 2022 - ObservationalCompleted
INSPIRE Continuation Post-Approval Study
OCS Lung System
Bronchiolitis Obliterans
NCT03868904Enrollment220StartJun 2019Primary CompletionOct 2021CompletionOct 2021 - Not applicableCompleted
OCS Liver PROTECT Continued Access Protocol
OCS Liver System
Liver Transplant
NCT04186221Enrollment74StartFeb 2020Primary CompletionFeb 2021CompletionFeb 2023 - ObservationalCompleted
OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection
OCS Lung System
OCS Lung System
NCT04194398Enrollment79StartDec 2018Primary CompletionSep 2021CompletionSep 2021 - Not applicableTerminated
OCS Liver DCD Trial
OCS Liver System
Liver Transplant
NCT04194437Enrollment9StartJul 2020Primary CompletionMar 2022CompletionDec 2024 - Not applicableCompleted
Donor After Circulatory Death Heart CAP Trial
Transplant
Heart Transplant
NCT04615182Enrollment90StartNov 2020Primary CompletionDec 2021CompletionJun 2022 - ObservationalActive, not recruiting
OCS Heart Perfusion Post-Approval Registry
OCS Heart System
Transplant
NCT05047068Enrollment350StartSep 2021Primary CompletionDec 2025est.CompletionDec 2029est. - ObservationalActive, not recruiting
OCS Liver Perfusion (OLP) Post-Approval Registry
OCS Liver
Liver Transplant
NCT05074160Enrollment166StartOct 2021Primary CompletionMar 2024CompletionJun 2026est. - ObservationalActive, not recruiting
OCS Heart EXPAND + CAP Continued Follow-Up
OCS Heart
Heart Transplant
NCT05096299Enrollment150StartSep 2015Primary CompletionAug 2026est.CompletionAug 2026est. - ObservationalCompleted
OCS Liver PROTECT Continuation Post-Approval Study
OCS Liver
Liver Transplant
NCT05096741Enrollment300StartJan 2016Primary CompletionNov 2021CompletionNov 2021 - ObservationalCompleted
OCS Liver PROTECT Continued Access Protocol (CAP) Continuation Post-Approval Study
OCS Liver
Liver Transplant
NCT05096754Enrollment74StartFeb 2020Primary CompletionFeb 2023CompletionFeb 2023 - ObservationalActive, not recruiting
OCS DCD Heart + CAP Continued Follow-Up
OCS Heart
Heart Transplant
NCT05741723Enrollment276StartNov 2019Primary CompletionOct 2026est.CompletionOct 2026est. - ObservationalRecruiting
US National OCS Heart Perfusion (OHP) Registry
OCS Heart
Heart Transplant
NCT05915299Enrollment100,000StartAug 2023Primary CompletionAug 2029est.CompletionAug 2033est. - ObservationalRecruiting
US National OCS Liver Perfusion (OLP) Registry
OCS Liver
Liver Transplant
NCT05940857Enrollment100,000StartOct 2021Primary CompletionOct 2031est.CompletionOct 2031est. - ObservationalRecruiting
US National TOP Registry
OCS Lung
Lung Transplant
NCT06513091Enrollment10,000StartJan 2025Primary CompletionNov 2034est.CompletionNov 2039est. - Not applicableRecruiting
Enhancing Heart Allograft Function With the OCS Heart System Trial
OCS Heart, Static Cold Storage (SCS)
Heart Transplant
NCT07145515Enrollment655StartJan 2026est.Primary CompletionJan 2027est.CompletionJul 2027est.
| Drug / Therapy | Link | ||
|---|---|---|---|
| Not applicable | Completed | Organ Care System, Cold Cardioplegia Solution | NCT00855712 |
| Not applicable | Completed | OCS Lung, Cold flush and storage | NCT01630434 |
| Not applicable | Completed | OCS Lung Preservation | NCT01963780 |
| Not applicable | Completed | Preservation of Hearts for Transplantation | NCT02323321 |
| Not applicable | Completed | OCS Liver | NCT02449694 |
| Not applicable | Completed | OCS™ Liver System, Control | NCT02522871 |
| Not applicable | Terminated | OCS Lung Preservation | NCT03343535 |
| Observational | Active, not recruiting | OCS Lung System | NCT03639025 |
| Not applicable | Completed | OCS Heart System, Cold Storage | NCT03831048 |
| Not applicable | Completed | OCS Heart System | NCT03835754 |
| Observational | Completed | OCS Lung System | NCT03868904 |
| Not applicable | Completed | OCS Liver System | NCT04186221 |
| Observational | Completed | OCS Lung System | NCT04194398 |
| Not applicable | Terminated | OCS Liver System | NCT04194437 |
| Not applicable | Completed | Transplant | NCT04615182 |
| Observational | Active, not recruiting | OCS Heart System | NCT05047068 |
| Observational | Active, not recruiting | OCS Liver | NCT05074160 |
| Observational | Active, not recruiting | OCS Heart | NCT05096299 |
| Observational | Completed | OCS Liver | NCT05096741 |
| Observational | Completed | OCS Liver | NCT05096754 |
| Observational | Active, not recruiting | OCS Heart | NCT05741723 |
| Observational | Recruiting | OCS Heart | NCT05915299 |
| Observational | Recruiting | OCS Liver | NCT05940857 |
| Observational | Recruiting | OCS Lung | NCT06513091 |
| Not applicable | Recruiting | OCS Heart, Static Cold Storage (SCS) | NCT07145515 |
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