XVIVO: can multiply sales by US-APPROVAL – CEO – Dagens Industri

XVIVO: can multiply sales by US-APPROVAL – CEO – Dagens Industri

XVIVO: can multiply sales by US-APPROVAL – CEO

                  2014-08-13 12:28
             

 STOCKHOLM (AFX) A Breakthrough for Xvivo, which means great opportunities for growth and paving the way for the introduction of other types of varmperfusionsprodukter.  To summarize Xvivos CEO Magnus Nilsson Tuesday's market approval for products and XPS STEEN Solution at the American FDA.  "It's a major breakthrough, the largest in its history," says Magnus Nilsson in an interview with the News Agency Direkt, and continues:  "To get an approval in the United States is the great proof that the product has gone through a hefty check. Obtaining approval of the toughest authority in the world even spilling over to Europe."  How will this approval in the United States that affect your future applications to the FDA?  "We aim to use this varmperfusionstekniken in other areas, such as for other types of bodies and for other types of applications, such as cancer treatments. Everywhere base material is in and with the approval completing and clear, so the application process with  the FDA eased the next times. Nevertheless, it is obvious that the FDA will look at the specific application, "he adds.  Xvivo is the First North-listed medical technology company that develops solutions and systems to evaluate and maintain organs outside the body. The products STEEN Solution and Xvivo Perfusion System, XPS, is developed for warm perfusion technique, which involves organs outside the body is kept warm.  In the USA there are more than 40 percent of all lung transplants in the world, and sales potential for FDA approval is thus great.  "The United States is the largest market in the world, so turnover has a few years ahead of course the potential to multiply. From now on, the clinics to pay for the products: previously we gave them away as part of the clinical trial. This means a lot of potential to increase revenue. Our disposable costs for a transplant in the United States around 130,000 crowns, so it becomes a very big difference for us from now on, "says Magnus  Nilsson.  Sales in the USA will then start immediately?  "Yes, sales can start from day one. Since it takes time of course to spread the technology, but there are some fifteen clinics in the United States who are already using the technology as part of a trial, and they will go on to buy in Instead of getting things. This will happen from day one, "he continues.  How will the US-launch that affect costs?  "It will mean a slight increase, but no gigantic increases. As sales will of course marketing costs will increase, but we are already selling products in the United States as both the sales staff and infrastructure are in place. There will be no jump in costs, but the costs will naturally move with the sales, "says Magnus Nilsson, adding that cash levels are expected to remain stable after the June private placement. 

Patrik Alen Falk +46 8 5191 7910
Direkt