China Medical Starts U.S. Trial For Tumor Therapy

China Medical Technologies (CMED) received conditional approval to begin a trial of its high intensity focused ultrasound [HIFU] tumor therapy system in the U.S. The trial will be conducted at the University of Washington Medical Center in Seattle.

In the test, the HIFU system will ablate targeted tumor tissue in the pancreas as a means to reduce pain associated with locally advanced or metastatic pancreatic cancer. The device raises the temperature in tumors to 70 degrees Celsius, with the intent of killing tumor cells immediately. The device has been approved in China since 1999, where it has treated more than 40,000 patients for a variety of cancer types, including pancreatic cancer.

China Medical Technologies received a conditional approval of its Investigational Device Exemption [IDE] application, pending an acceptable and timely response to a number of questions posed by the FDA. The Institutional Review Board of the University of Washington must also give its OK to the clinical trial before it can begin.

Earlier this year, China Medical Technologies signed up EDAP TMS S.A. of France to distribute the HIFU machines in Europe and Russia. China Medical has begun the process of seeking CE Mark for the product there.

Besides the HIFU tumor therapy system, China Medical also has a diagnostic products division that markets the Enhanced Chemiluminescence Immunoassay [ECLIA] line of products. These include gene analysis reagents and single photon counters in an in-vitro diagnostics system that outperforms radio and enzymatic immunoassays at lower cost.

In 2006, the HIFU division provided 60% of the China Medical’s revenue, but recent additions to the ECLIA line will bring it up to rough parity with HIFU revenues.

China Medical made its IPO on Nasdaq in 2005 at $15 per share. Monday, following the latest announcement, its shares rose $1.22 to $35.85, an all-time high. At this price, China Medical has a market capitalization of $981 million.

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Disclosure: none.