Guided Therapeutics Ships LuViva Devices to China for Start of Clinical Trial; Receives Additional $100,000 Payment

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.

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.