Regulatory News:
For the first time lung transplantations have been performed in North America using the STEEN Solution(TM) technology. The transplantations were done in Toronto, Canada, and are part of the study that is being carried out as a basis for the application for sales approval in the USA and Canada. “It is very good to be able to observe that three further patients with lung disease have been able to be helped by means of this new technology, that it has been adopted by North America’s most experienced lung transplantation clinic and that the clinical study involving our unique product is now well underway,” says Magnus Nilsson, Vitrolife’s CEO.
At the beginning of September Vitrolife (STO: VITR) announced that approval had been received from the Canadian authorities to start a study with STEEN Solution(TM). 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. It is within the framework of this study that the first three transplantations have now been carried out in Toronto in Canada.
The first lung transplantation outside Sweden using the STEEN Solution(TM) technology was recently performed. The transplantation was carried out in one of the large EU countries and within the region there are a further number of clinics in the starting blocks, ready to use the technology. Earlier on in the development and the first clinical use eight transplantations have been carried out using STEEN Solution(TM) at the University Hospital of Lund, where this pioneering technology was developed under the leadership of Professor Stig Steen.
Vitrolife’s product STEEN Solution(TM) 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(TM) into the organ’s system of vessels at normal body temperature before possible use.
With the STEEN Solution(TM) 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(TM) 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.
Vitrolife is today the market leader within the area of lung preservation solutions with its product Perfadex(R) and more than 90 percent of all lung transplantations in the world are performed using this product. Together with STEEN Solution(TM), Perfadex(R) is also part of the new method for functional testing and preservation of lungs outside the body.
STEEN Solution(TM) has already been approved for sales in Europe and Australia. The patent has so far been approved in Australia and the USA.
October 21, 2008 Kungsbacka, Sweden Magnus Nilsson CEO
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 AB (publ), Faktorvagen 13, SE-434 37 Kungsbacka, Sweden. Corporate identity number 556354-3452.
Tel: +46 31 721 80 00. Fax: +46 31 721 80 90. E-mail: [email protected]. Homepage: www.vitrolife.com.
This is a translation of the Swedish version of the press release. When in doubt, the Swedish wording prevails.
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