Recruitment completed for NOVEL study in the US on STEEN Solution™ and XPS™
Inclusion of all 220 (110 + 110) patients is now completed in the NOVEL study which is being carried out in the US on STEEN Solution™ and XPS™. This clinical study will form the basis of the company’s PMA (Pre-market Approval) application to the FDA. Approximately 40 percent of all lung transplantations in the world are done in the US and STEEN Solution™ and XPS™ have already been approved for sales in the US under an HDE (Humanitarian Device Exemption) approval.In March 2014 the Advisory Panel convened by the FDA voted unanimously, by 10 votes to 0, that the XPS™ System with STEEN