Medical imaging company DOBI Medical International announced yesterday that it had entered into an agreement with the China Center for Pharmaceutical International Exchange (CCPIE), designed to increase the company's presence in the country.
Under the terms of the agreement, CCPIE will work with DOBI and the Chinese State Food and Drug Administration, the country's US-FDA equivalent, to oversee the product approval cycle required by SFDA for DOBI's ComfortScan system, the company said.
ComfortScan is an imaging system that identifies abnormal vasculatization in the breast. The ComfortScan system is not commercially available in the US as it is limited to investigational use as an adjunct to mammography until approved by the FDA, which cannot be guaranteed.
New Jersey, US-based DOBI has a global distribution network of 12 international distributors covering markets in 16 countries.
According to DOBI's announcement, more than 300 million women are at risk for breast cancer in China. In the past 10 years, diagnosis of breast cancer has increased by at least 27 percent and death rates in China's major cities have risen approximately 38 percent, replacing lung cancer as the most immediate cancer threat in China and reaching the levels of western countries. 40 percent of Chinese women diagnosed with breast cancer die within five years because the cancer is already very advanced when diagnosed.
"Statistics in China, alone, prove there is a great need for the benefits that we believe are inherent in a health exam utilizing our ComfortScan technology," reported Robert Ellis, Vice President of Marketing, Sales and Service for DOBI Medical International.