The fourth of the total of twelve patients included in the USA study for STEEN Solution™, and which enables sales approval in the important USA market, has now received a transplant. The first transplantation was carried out in September and four transplantations have thus now been carried out at four centres. A fifth centre, Duke University, has been included in the study, and it is anticipated that they will be able to start within approximately one month there.
A study is being carried out at present in the USA, comprising 12 patients who are being given transplants after treatment of donor lungs using STEEN Solution™. Five well-reputed lung transplant centres in Baltimore, New York, Boston, Denver and Durham are participating. The study has been devised in consultation with the FDA and complements the previously published Canadian study on 22 patients.
Sales approval in the USA is expected if the study obtains results that correspond to those obtained in the study carried out in Canada. Approval would mean that STEEN Solution™ could begin to be used clinically in the USA, which would then open up a large market, as approximately half of all lung transplants in the world are done in the USA.
The STEEN Solution™ method involves a fluid (STEEN Solution™) being pumped at body temperature through the organ’s blood vessels, whereupon the organ is given the chance to recover and is tested for function. The study includes lungs that were initially assessed not to be sufficietntly functional for use in transplantation. Using the STEEN Solution™ method the number of organs available for transplantation can thereby be increased and fatalities and the time on the waiting list reduced.
“After having met and overcome more bureaucratic problems than we had expected to start the study, we have now relatively quickly got through a third of the study, which is a big step towards sales approval in the USA,” says Magnus Nilsson, CEO.
Gothenburg, October 11, 2011
VITROLIFE AB (publ)
Queries should be addressed to:
Magnus Nilsson, CEO, phone +46 31 721 80 61
Anne-Lie Sveder, CFO, phone +46 31 721 80 13