Medical technology company Xvivo Perfusion AB (STO:XVIVO) announced on Friday the submission of the PMA (Premarket Approval) application for the XPS with STEEN Solution to the FDA.

Reportedly, the NOVEL Extension Clinical trial, that completed enrolment in 2017, constitutes the basis of the company's PMA application. This clinical trail was a six-year effort with the company's largest multicentre study ever performed in the largest market in the world and is therefore an important milestone for the company.

XPS is an integrated system that provides clinicians the flexibility to evaluate lungs before transplantation by means of a standardised and simplified procedure. The XPS System with STEEN Solution allows marginal quality lungs, that initially failed to meet standard transplant criteria, to be perfused and ventilated at normothermic conditions for up to four hours, thus providing an opportunity for surgeons to reassess transplant suitability.

According to the company, the XPS and STEEN Solution are used worldwide with good clinical results. The XPS and STEEN Solution have already been CE-marked and thus approved for sales on the European market and are also approved for sales in Canada and Australia.

In March 2014, the FDA Advisory Panel voted unanimously 10-0 that the XPS System with STEEN Solution met the requirements for HDE (Humanitarian Device Exemption) approval by proving safety. In August 2014, XVIVO Perfusion received HDE approval from the FDA for the XPS with STEEN Solution for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex-vivo function of the lungs can be reassessed for transplantation.

HDE approval entails certain restrictions, amongst other things that no more than 8,000 patients may be treated per year under HDE approval and that separate institutional IRB approval may be required for treatment. A PMA will no longer entail any such restrictions, the company added.

Xvivo Perfusion develops solutions and systems for assessing and preserving organs outside the body and for selecting usable organs and maintaining them in optimal condition pending transplantation.