China Medical Technologies has received a conditional approval for its Investigational Device Exemption (IDE) application from the United States Food and Drug Administration (FDA) to begin a clinical trial using its high intensity focused ultrasound (HIFU) tumor therapy systems in a limited number of patients with pancreatic cancer. The conditions of the approval include a requirement for the company to provide responses to the questions raised by the FDA within a specified period of time.
The clinical trial will be performed at the University of Washington Medical Center in Seattle after receiving approval from the Institutional Review Board (IRB) of the University. The company's HIFU tumor therapy system is intended in this trial to ablate targeted tumor tissue of the pancreas with an indication for the palliation for pain associated with locally advanced or metastatic pancreatic cancer.
The State Food and Drug Administration (SFDA) of People’s Republic of China (PRC) approved HIFU tumor therapy system for sale in 1999. To date, over 40,000 tumor patients, including patients with pancreatic, liver, breast, kidney and other solid tumors in pelvic cavity, received treatments by using the Company's HIFU tumor therapy system in the PRC.
“We are excited to have received the conditional approval of our IDE application from the FDA. We believe this marks an important milestone towards our application for pre-market approval of our HIFU tumor therapy system in the United States,” said Mr Xiaodong Wu, Chairman and CEO of the company. “We believe that our extensive clinical experience in the PRC together with the experience of preclinical animal tests performed in the United States at the University of Washington for the IDE application will help us demonstrate the clinical safety and efficacy of using our HIFU system in treating pancreatic cancer patients during the clinical trial.”