XVIVO has been granted Breakthrough Device Designation from the
The US is the largest liver transplant market globally with more than 8,600 livers transplanted in 2021[1]. In that year, the US performed more transplants than the next three largest markets combined (
The overall goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to life-saving technologies by expediting their development, assessment, and review, through the FDA. As part of this program, the FDA will provide XVIVO with priority review and interactive communication (“sprint discussions”) which provide a faster mechanism for communication with FDA compared to Pre-Sub meetings. This enables device development and review to move forward in an efficient manner and achieve a faster path to market access. The Breakthrough Devices Program not only expedites FDA review but also has the potential to facilitate
“In line with our strategy to become the market leader within abdominal transplantation we have taken a decision to commercialize our liver technology in the US. FDA’s decision to grant a breakthrough designation indicates that the technology is innovative with the potential to be an improvement upon what is available on the market today. With more than 10 years of clinical experience, the Liver Assist is the most used device globally for machine perfusion of livers. As we believe in the extended life of organs we are very much looking forward to expanding this technology in the US after an FDA approval” says
[1] OPTN (Organ procurement and transplantation network –
[2] GODT (Global observatory on organ donation and transplantation)
[3] XVIVO Market Intelligence & Forecast
[4] XVIVO Market Intelligence & Forecast
[5] https://www.nejm.org/doi/full/10.1056/NEJMoa2031532
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