PEACHTREE CORNERS, Ga.–(BUSINESS WIRE)–#HPV–Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, announced today that its Chinese partner, Shandong Yaohua Medical Instrument Corporation (SMI), had received ethics board approval and placed LuViva devices at two of the three participating hospitals for clinical trials aimed at achieving Chinese FDA approval. The clinical study is expected to start next month, include approximately 400 patients and be completed this year or early next year. Participating hospitals include Fudan University Hospital, Qilu Hospital of Shandong University and Peking University People’s Hospital. The physicians testing LuViva at these institutions represent the leadership of the Chinese obstetrics and gynecology community and include Professor Dr. Wei Lihui of Peking University and Dr. Kong Beihua of Qilu Hospital. Dr. Wei is former National Chairwoman of the Chinese Society of Obstetrics and Gynecology and Dr. Kong is currently the vice chairman of the Chinese Society of Obstetrics and Gynecology.
SMI also placed orders for additional LuViva devices and paid $100,000 to GTHP as part of an existing purchase order that totals $530,000, $252,000 of which has been paid thus far in 2021. The remaining $278,000 is due over the next five months. GTHP holds another purchase order from SMI for $2.5 million, $620,000 due upon SMI filing the clinical study results with Chinese FDA and $1,880,000 due upon approval by Chinese FDA. A recently signed distribution agreement then calls for minimum orders of $72 Million over the first four years post Chinese FDA approval.
“We are delighted that SMI has been able to recruit influential thought leaders to work with our products”, said Gene Cartwright, CEO of Guided Therapeutics. “These recent developments auger well for the commercial viability of LuViva in China, the world’s most populous nation and second fastest growing medical device market”.
According to the World Health Organization, cervical cancer is 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. It is believed mortality due to cervical cancer has been increasing in China. In response, China has increased efforts to screen more women, especially in rural areas where the laboratory infrastructure for traditional screening tests is lagging. Because LuViva does not require a laboratory infrastructure and produces an immediate result at the point of care, it is well suited to screening women for cervical cancer in these environments.
About Guided Therapeutics
Guided Therapeutics, Inc. (OTCQB: 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, 2020 and subsequent filings.
Contacts
Mark Faupel
Guided Therapeutics
770-242-8723