A Medical Device Daily

Vitrolife (Kungsbacka, Sweden) has received notice of allowance regarding a patent in the U.S. for Steen Solution, a solution for functional testing of lungs outside the body before transplantation. The patent contains both product and method claims, which means that both the composition of the solution and its use will be patent protected.

Vitrolife's Steen Solution is part of a new method for functional testing of lungs outside the body which enables donated lungs to be tested outside the body for possible use. The method thus has the possibility to considerably increase the number of organs available for transplantation.

Steen Solution was developed by Professor Stig Steen and the transplantation team at the University Hospital of Lund has implemented the method. During 2006, seven transplantations were performed.

The patent that the U.S. Patent and Trademark Office has sent a notice of allowance for with regard to Steen Solution is valid until 2021. The patent contains both product and method claims, which means that both the composition of the solution and its use will be patent protected. Vitrolife has applied for a patent for Steen Solution in all markets that are assessed to be important. Approval previously has been obtained in Australia.

Activities to obtain sales approval in the U.S. before the FDA are "proceeding according to plan," the company said.

About 2,600 lung transplantations per year are performed in the world today. With its product Perfadex, Vitrolife has about 90% of the world market for lung transplantation solutions. Perfadex is also used together with the Steen Solution in the new method for functional testing of lungs outside the body.

The solution is expected to lead to "five to 10 times" as many lung transplantations being able to be carried out, as the need for donated organs using today's methods considerably exceeds supply, the company said.

Vitrolife is a global biotechnology/medical device group that develops 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.