LONDON - IstoTis BV is expected to float on the Amsterdam Stock Market in October. The price range will be announced next week, and the company expects the money raised to see it through to break even in mid-2005. UBS Warburg and ABN AMRO Rothschild are managing the float.

Expenditures are due to rise when the company, which specializes in tissue engineering, begins a series of clinical trials. These are of tissue-engineered bone grafts cultured from bone marrow cells, epidermal cultured skin grafts, and of a biocompatible filler for bones.

IsoTis, based in Bilthoven, the Netherlands, has raised EUR26 million in venture funding since it was founded in 1996 as Matrix Medical. Currently, its main focus is on orthopedic and wound-healing applications of cultured bone, cartilage and skin.

The company already has several small medical devices made from a proprietary biomaterial on the market in Europe, and also has turnover from sales of cultured autologous skin. Last week it announced a deal with two hospitals in Germany to supply autologous keratinocyte sheets for burn patients, to collaborate on the development of an autologous cultured full skin equivalent, and to develop improved ways to deliver keratinocytes for wound healing. No financial terms were disclosed.

The two hospitals are part of the Berufsgenossenschaften, a statutory accident insurance institution covering around 40 million German employees. By law, all German employers are members of this insurance body, which runs 25 hospitals and clinics.

Clemens van Blitterswijk, CEO of IsoTis said, "Discussions are under way to expand the collaboration to several more clinics later this year, which would make IsoTis one of the largest commercial manufacturers of autologous keratinocyte sheets in Europe. The considerable clinical expertise . . . and the large numbers of insured [people] the clinics cover in Germany will also provide us with invaluable feedback for our R&D programs."

At present, medical devices made from synthetic materials require far less testing than drugs. However, IsoTis recognizes that its aim of being able to replace any tissue with a grown replica makes these devices more 'drug-like.' This means clinical trials will have to be more extensive.

The company contributes to EUCOMED, a pan-European body of regulators, academics and companies that is trying to come up with proposals for how this new generation of tissue-engineered devices should be regulated.