All patients included in the NOVEL trial in the USA with STEEN Solution™

The NOVEL trial is a multicenter study performed at 6 sites in USA and was designed to safely increase the percentage of usable lungs from the donor pool. In the study, clinical outcomes associated with ex-vivo lung perfusion (EVLP) of initially rejected or marginal lungs were compared with contemporary matched controls. A total of 42 patients received transplants using the STEEN Solution™ method and was matched with 42 control patients. The initial results indicate that initially rejected lungs that were perfused with Steen Solution™ perform as well as lungs that initially were deemed good for use. This is in line with experiences from centers in Europe and Canada where EVLP with STEEN Solution™ is in clinical practice.

At the International Society of Heart and Lung Transplantation (ISHLT) conference in Montréal, the interim results were presented and confirmed previous single center experiences that initially rejected lungs evaluated with Ex Vivo Lung Perfusion (EVLP) perform similarly to standard criteria lungs after transplantation. The results also indicate that the use of EVLP to screen the marginal donor pool is safe. At the same conference, the combined outcome data from Toronto (Canada), Vienna (Austria) and Paris (France) were presented with 140 assessed and 114 transplanted lungs. More than 240 patients have now received lungs evaluated with STEEN Solution™ method which would have otherwise remained unused without this technology.

“The clinical results from the study are very encouraging and demonstrates that STEEN Solution™ safely makes many more organs available for this life-saving treatment of patients with end-stage lung deceases” says Dr Magnus Nilsson, CEO of XVIVO Perfusion.

July 9, 2013

Gothenburg
XVIVO Perfusion AB (publ)
Magnus Nilsson
CEO