Guided Therapeutics Reports New Progress with Chinese FDA and Increased Sales Forecast from Shandong Medical Device Technology Company
PRESS RELEASE Businesswire
Jun. 5, 2019, 09:05 AM
Guided Therapeutics, Inc. (Pink Sheets: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, announced that it had received a new communication regarding regulatory approval of its LuViva line of products in China. 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. 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. 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. As a result, Shandong has revised its forecast next year upward to include orders of 300 LuViva devices and 3 million disposable Cervical Guides.
"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.”
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.
About Guided Therapeutics
Guided Therapeutics, Inc. (Pink Sheets: GTHP) is the maker of a rapid and painless testing platform based on its patented biophotonic technology that utilizes light for the early detection of disease at the cellular level. The Company’s first product is the LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care. In a multi-center clinical trial with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports. For more information, visit: www.guidedinc.com.
The Guided Therapeutics LuViva® Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use in the U.S. LuViva, the wave logo and "Early detection, better outcomes" are registered trademarks owned by Guided Therapeutics, Inc.
Forward-Looking Statements Disclaimer: A number of the matters and subject areas discussed in this news release that are not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics’ actual future experience involving any of or more of such matters and subject areas. Such risks and uncertainties include those related to the early stage of commercialization of products, the uncertainty of market acceptance of products, the uncertainty of development or effectiveness of distribution channels, the intense competition in the medical device industry, the sufficiency of capital raised in prior financings and the ability to realize their expected benefits, the uncertainty of future capital to develop products or continue as a going concern, the uncertainty of regulatory approval of products, and the dependence on licensed intellectual property, as well as those that are more fully described from time to time under the heading "Risk Factors” in Guided Therapeutics’ reports filed with the SEC, including Guided Therapeutics’ Annual Report on Form 10-K for the fiscal year ended December 31, 2017 and subsequent filings.
PRESS RELEASE Businesswire
Jun. 5, 2019, 09:05 AM
Guided Therapeutics, Inc. (Pink Sheets: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, announced that it had received a new communication regarding regulatory approval of its LuViva line of products in China. 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. 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. 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. As a result, Shandong has revised its forecast next year upward to include orders of 300 LuViva devices and 3 million disposable Cervical Guides.
"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.”
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.
About Guided Therapeutics
Guided Therapeutics, Inc. (Pink Sheets: GTHP) is the maker of a rapid and painless testing platform based on its patented biophotonic technology that utilizes light for the early detection of disease at the cellular level. The Company’s first product is the LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care. In a multi-center clinical trial with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports. For more information, visit: www.guidedinc.com.
The Guided Therapeutics LuViva® Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use in the U.S. LuViva, the wave logo and "Early detection, better outcomes" are registered trademarks owned by Guided Therapeutics, Inc.
Forward-Looking Statements Disclaimer: A number of the matters and subject areas discussed in this news release that are not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics’ actual future experience involving any of or more of such matters and subject areas. Such risks and uncertainties include those related to the early stage of commercialization of products, the uncertainty of market acceptance of products, the uncertainty of development or effectiveness of distribution channels, the intense competition in the medical device industry, the sufficiency of capital raised in prior financings and the ability to realize their expected benefits, the uncertainty of future capital to develop products or continue as a going concern, the uncertainty of regulatory approval of products, and the dependence on licensed intellectual property, as well as those that are more fully described from time to time under the heading "Risk Factors” in Guided Therapeutics’ reports filed with the SEC, including Guided Therapeutics’ Annual Report on Form 10-K for the fiscal year ended December 31, 2017 and subsequent filings.
