01.23.15
BSD Medical Corporation said its Chinese distributor, Dalian Orientech Co. Ltd., has won approval from China’s Food and Drug Administration (CFDA) to market and import the BSD-2000 Hyperthermia system (BSD-2000).
“Receiving renewal of the approval from the CFDA is a significant milestone for us and for Orientech, and it is a step forward to deliver the best healthcare products to hospitals and their patients around the world,” said Sam Maravich, vice president of International Sales and Marketing at BSD Medical. “While this was a long and difficult process, we are very excited that the process is now complete.”
BSD has a long-term exclusive distributor agreement with Orientech. The agreement requires Orientech to make yearly minimum purchases of the BSD-2000 over a four-year period beginning upon receipt of the marketing and import license renewal.
China has the world’s largest population and ranks as one of the fastest-growing markets on the planet. China increased medical and healthcare spending by 26 percent in 2013 and 15.1 percent in 2014 to $133 billion. McKinsey & Company forecasts expect healthcare spending to increase to $1 trillion annually by 2020 due in large part to an aging population. China has more than 10,000 hospitals with oncology departments. The Chinese medical device market is mostly supplied by imported products or devices made locally by multinational joint ventures.
The BSD-2000 – developed and patented exclusively by BSD – delivers localized therapeutic heating (hyperthermia) by applying radiofrequency (RF) energy. The BSD-2000 creates a central focusing of energy that can be electronically focused to target the shape, size, and location of a tumor, thus providing dynamic control of the heating delivered to the tumor region. The BSD-2000 has Humanitarian Device Exemption (HDE) marketing approval from the U.S. Food and Drug Administration for use in conjunction with radiation therapy to treat cervical cancer patients who are ineligible for chemotherapy. The BSD-2000 also has CE marking approval for commercial sale in Europe.
BSD Medical develops systems to treat cancer and benign diseases using heat therapy delivered using focused microwave energy and radiofrequency. BSD’s product lines include ablation and hyperthermia treatment systems. BSD’s microwave ablation system has been developed as a standalone therapy to ablate and destroy soft tissue.
The company is based in Salt Lake City, Utah.
“Receiving renewal of the approval from the CFDA is a significant milestone for us and for Orientech, and it is a step forward to deliver the best healthcare products to hospitals and their patients around the world,” said Sam Maravich, vice president of International Sales and Marketing at BSD Medical. “While this was a long and difficult process, we are very excited that the process is now complete.”
BSD has a long-term exclusive distributor agreement with Orientech. The agreement requires Orientech to make yearly minimum purchases of the BSD-2000 over a four-year period beginning upon receipt of the marketing and import license renewal.
China has the world’s largest population and ranks as one of the fastest-growing markets on the planet. China increased medical and healthcare spending by 26 percent in 2013 and 15.1 percent in 2014 to $133 billion. McKinsey & Company forecasts expect healthcare spending to increase to $1 trillion annually by 2020 due in large part to an aging population. China has more than 10,000 hospitals with oncology departments. The Chinese medical device market is mostly supplied by imported products or devices made locally by multinational joint ventures.
The BSD-2000 – developed and patented exclusively by BSD – delivers localized therapeutic heating (hyperthermia) by applying radiofrequency (RF) energy. The BSD-2000 creates a central focusing of energy that can be electronically focused to target the shape, size, and location of a tumor, thus providing dynamic control of the heating delivered to the tumor region. The BSD-2000 has Humanitarian Device Exemption (HDE) marketing approval from the U.S. Food and Drug Administration for use in conjunction with radiation therapy to treat cervical cancer patients who are ineligible for chemotherapy. The BSD-2000 also has CE marking approval for commercial sale in Europe.
BSD Medical develops systems to treat cancer and benign diseases using heat therapy delivered using focused microwave energy and radiofrequency. BSD’s product lines include ablation and hyperthermia treatment systems. BSD’s microwave ablation system has been developed as a standalone therapy to ablate and destroy soft tissue.
The company is based in Salt Lake City, Utah.