CE Mark

From 1995 to 1999, the Company conducted an extensive clinical trial for the Ablatherm in the European Union. The long term patient follow-up is still on-going.

This trial, the European Multicentric Study, involved a total of 559 patients suffering from localized prostate cancer and included six sites in France, Germany and The Netherlands.

The primary goals of the trial were to assess the safety and effectiveness of the Ablatherm. There are primarily two methods to evaluate the presence of cancerous tissue in the prostate.
The first method is based on biopsies. A sextant biopsy is performed inside the prostate to reveal the presence of a tumor.
The second method is based on a blood test, the Prostate Specific Antigen ("PSA"), which, although not specific to cancer tumors, measures the proliferation of cells inside the prostate.

An interim analysis performed on 559 patients included 402 patients treated with the Ablatherm device as a first-line therapy. Of these patients, 81.4% had a normal PSA and 87.2% had negative biopsies at the last follow-up and were considered as cancer free.
The trials also included 157 patients who underwent an Ablatherm treatment as a salvage therapy after a previous failed therapy (hormonotherapy, radiation or prostatectomy). Of these patients, 80.7% and 67.9% had negative biopsies and normal PSA after treatment, respectively.

Based on these results, the Company obtained, in January 2000, the CE Mark which allows the Company to market the Ablatherm in the European Union. In February 2001, the French Urology Association ("AFU") began an independent clinical trial in order to confirm the efficacy and safety results observed in the European Multicentric Study, and to evaluate the therapy related costs. Patient recruitment was successfully performed at eight investigational sites, six of which used a mobile machine. Patient enrolment was completed in a 11-month period with 117 patients included. Patient follow-up is planned for two years, with intermediate assessment at one year (end of 2003).

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