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XVIVO has received approval from the Swedish MPA to begin clinical studies with the company’s new products for heart preservation

XVIVO has received approval from the Swedish Medical Products Agency (MPA) to begin the clinical study with XVIVO's heart preservation products. This means that the study can be started in Sweden and that applications to the other EU countries that will participate in the study can be submitted to the national ethics committees.

XVIVO's heart preservation study is a randomized study planned to include eight centers in seven European countries and comprises a total of 138 patients (69 + 69 patients). The aim of the study is to clinically show that the technology is safe and improves the preservation of the donated heart during transport. The clinical study is an important step for regulatory submission in Europe for the heart preservation products.

The products for heart preservation consist of a portable machine with associated sterile disposable products, as well as a patented innovative solution that perfuse and oxygenate the heart during transportation and preservation. The technology is developed by Professor Stig Steen at Igelösa Life Science and it is a work that started approximately ten years ago. Over the past two years, XVIVO has further developed the products and setup large-scale production of the heart preservation fluid.

Approximately 7,500 heart transplants are performed in the world each year and the limiting factor for more heart transplants being performed is the lack of donated hearts and that the generally accepted maximum transport time today is approximately four hours. The new preservation method includes a machine that supplies the heart with important substances in an oxygenated solution before transplantation. Published pre-clinical experiments using the new method has shown that the preservation time for the donated heart could be significantly extended and that the donated heart´s function could be better preserved. Professor Johan Nilsson has earlier this year presented the good results from the first six patients from the heart transplant study performed at Lund University Hospital. The results of the study indicate that the method is safe to use clinically.

“The approval of the application for clinical studies for our heart preservation products by the Swedish MPA is an important milestone passed. The company intends to continue working intensively to clinically document this groundbreaking heart preservation technology in order to reach regulatory approval in all major markets, which will enable more patients to have a life-saving heart transplant.,” says Magnus Nilsson, CEO of XVIVO Perfusion.

May 15, 2019
XVIVO Perfusion AB (publ)
Magnus Nilsson, CEO

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