Vitrolife: Approval For STEEN Solution™ Study - Functional Testing And Preservation Of Lungs Outside The Body

Main Category: Transplants / Organ Donations
Article Date: 31 Aug 2008 - 0:00 PDT

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Vitrolife has received approval from the Canadian authorities to start a study with STEEN Solution™. The study, which has been designed in consultation with the American FDA, is planned for quarters three to four of 2008 and will be the key element in the application for sales approval in USA and Canada.

Vitrolife's product STEEN Solution™ is part of a new method for functional testing and preservation of lungs outside the body. The technology makes it possible for the first time to test the function of donated lungs outside the body by pumping STEEN Solution™ into the organ's system of vessels before possible use.

With the STEEN Solution™ method, the number of potential organs that can be transplanted increases considerably. In the USA, for example, less than 20 percent of the lungs donated are transplanted today, due to uncertainty about the function of the organ. In time the STEEN Solution™ method can lead to a fivefold to tenfold increase in the number of lung transplantations carried out, as the need for donated organs using today's methods considerably exceeds supply. So far 8 transplantations have been performed using this method, all at the University Hospital of Lund.

Vitrolife is today the market leader within the area of lung preservation solutions with its product Perfadex® and more than 90 percent of all lung transplantations in the world are performed using this product. Together with STEEN Solution™, Perfadex® is also part of the new method for functional testing and preservation of lungs outside the body.

STEEN Solution™ has already been approved for sales in Europe and Australia. The patent has so far been approved in Australia and the USA.

Vitrolife is a global biotechnology/medical device Group that works with developing, manufacturing and selling advanced products and systems for the preparation, cultivation and storage of human cells, tissue and organs. The company has business activities within three product areas: Fertility, Transplantation and Stem Cell Cultivation. The Fertility product area works with nutrient solutions (media) and advanced consumable instruments such as needles and pipettes, for the treatment of human infertility. The Transplantation product area works with solutions and systems to maintain tissue in optimal condition outside the body for the required time while waiting for transplantation. The Stem Cell Cultivation product area works with media and instruments to enable the use and handling of stem cells for therapeutic purposes.

Vitrolife today has approximately 140 employees and the company's products are sold in more than 80 markets. The head office is in Kungsbacka, Sweden, and there are subsidiaries in Sweden, USA, Australia and Italy. The Vitrolife share is listed on the OMX Nordic Exchange Stockholm's Nordic Small Cap list.

Vitrolife