>> As previously reported, the Company made modifications to the HGS [Holly Graft System] device and its clinical trial protocol in response to failures of its HGS device in initial clinical work conducted in Australia. After completion and testing of these modifications, the Company resumed clinical trials of the HGS on September 8, 2005, in Germany. In total, the Company has enrolled 32 patients in two clinical centers in Germany and one in Australia. It has been determined that three of these implants have occluded, including one of the previously reported occlusions in Australia. Additionally, one patient died from causes unrelated to the performance of the device. One patient had the device removed prior to the completion of the procedure. Based on the data collected by its investigating centers, the Company believes the remaining 27 patients continue to be symptom free and in good health. <<
Yet the tone of the PR is uniformly positive.
I had an interest in this company at one time, but I lost confidence in their technology after the Australian failures.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”