Tuesday, October 15, 2019 2:31:03 PM
1. According to the Company’s partner and distributor for China, Shandong Yaohuo Medical Device Technology Company, Ltd., the Chinese FDA will request a relatively small clinical trial in China of 60 to 120 patients, to be conducted at two hospitals. The study is expected to begin this summer and be completed within three months, after which Shandong will file final paperwork for approval.
2. In addition, LuViva was featured at China’s largest biotech investment conference, the 5th BFC Healthcare Investment Conference held in Shanghai on May 15-17, 2019.
3. After the conference, Shandong reported that it had signed several new sub-distributors for China and that LuViva had placed 16th out of the 100 best investments in a poll of conference participants.
4. As a result, Shandong has revised its forecast next year upward to include orders of 300 LuViva devices and 3 million disposable Cervical Guides.
5. “Significant progress is being made on both the regulatory and commercial fronts for LuViva in China, which is likely our largest market given the size of the population and clinical need,” said Gene Cartwright, CEO of Guided Therapeutics. “We look forward to working with Shandong and the Chinese FDA to bring better healthcare to the women of this vast and important country.”
6. According to the World Health Organization, cervical cancer is ranked as one of the most frequent cancers in women in the world and in China it is the second most common cancer among women. China has a population of approximately 560 million women above 15 years of age, who are at risk of developing cervical cancer. Current estimates indicate approximately 100,000 new cases of cervical cancer are diagnosed each year and 30,000 deaths occur annually due to cervical cancer in China.
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