BioWorld International Correspondent

IsoTis SA aims to start selling its OsSatura BCP synthetic bone substitute product in Europe this quarter, following its receipt of the CE mark, which clears the product for marketing throughout the European Union. The news lifted its share price 32 percent to close at CHF1.03 during trading on the Swiss Stock Exchange last Wednesday.

The Lausanne, Switzerland-based tissue engineering company completed the equivalent U.S. filing - a 510(k) - with the FDA in January, company spokesman Hans Herklots told BioWorld International. "If we get approval in the middle of the year, that would be fantastic," he said.

The company launched the product, which is aimed at broad orthopedic indications, at the American Academy of Orthopedic Surgeons meeting in New Orleans last week. IsoTis is seeking partners to distribute OsSatura BCP in the U.S., while it will leverage its existing network in Europe. It is setting up post-marketing studies to support sales efforts.

OsSatura BCP represents an important component of IsoTis' recently revised strategy, which it unveiled in January. The company is paring back its R&D activities in order to conserve cash and focus on projects with near-term revenue potential. IsoTis decided to can the development of a more ambitious product, VivescOs, in favor of OsSatura BCP, following a comparison of in vivo data that indicated only a minor difference in performance between the two. (See BioWorld International, Jan. 15, 2003.)

Although VivescOs was marginally superior, it is technically more involved as it requires the ex vivo culture and subsequent reintroduction to patients of osteoblasts (bone-forming cells) harvested from their biopsies. "It was very clear we would have a harder time getting that through to the market," said Herklots.

OsSatura BCP, in contrast, is an inert material. It consists approximately of 80 percent hydroxyapatite and 20 percent beta-tricalcium phosphate. IsoTis said it promotes both osteoconductivity, or guiding bone formation, and osteoinductivity, or inducing bone to grow in and on its scaffold structure. The latter feature, Herklots said, arises from its macroscopic design and microporous structure, and is not available in rival products.