Organ preservation solution company Bridge to Life has acquired Medica SpA’s VitaSmart Hypothermic Machine Perfusion System.
Last month, Bridge to Life announced the completion of more than 5,000 liver perfusions worldwide using its hypothermic oxygenated perfusion (HOPE) liver preservation technique in combination with the Italian company’s VitaSmart system.
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US-based Bridge to Life’s HOPE technique for liver preservation in storage or during transportation, continuously pumping a solution through the organ at temperatures between 1°C and 10°C. This provides an alternative to standard cold storage methods in which organs must be kept at colder temperatures.
Stating that it is thrilled to now own VitaSmart, Bridge to Life CEO Don Webber said the system has enabled clinicians to implement HOPE protocols with ease and efficiency.
“The system’s user-friendly design and minimal monitoring requirements make it a game-changer for organ preservation,” said Webber.
Financial terms of the agreement, which also gives Bridge to Life exclusive global trademark rights and the ability to register the VitaSmart name worldwide, have not been disclosed.
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By GlobalDataThe company is aiming to have a US Food and Drug Administration (FDA) application for VitaSmart ready for submission by the first quarter of 2025.
Webber continued: “The results from the one-year patient follow-up on our pivotal US study are complete and we are extremely impressed with the clinical outcomes, including demonstrated statistical superiority between study and control arms for the primary endpoint (early allograft dysfunction) and shorter length of hospital stay following transplantation.
“This acquisition positions us to expand access to this transformative technology for US transplant centres, organ procurement organisations and, most importantly, patients awaiting viable livers.
“Full ownership of VitaSmart enhances our enterprise value and strengthens our ability to meet global demand.”
The HOPE pivotal study (NCT05045794) evaluated the safety and effectiveness of VitaSmart by comparing clinical outcomes in patients undergoing liver transplantation with ex-vivo liver preservation using static cold storage (SCS) followed by hypothermic oxygenated machine perfusion (HOPE) versus SCS only.
In September 2024, Bridge to Life reported data from three Italian trials for HOPE, demonstrating that the technique improved outcomes in redo-liver transplantation.
