An email has been sent to your address with instructions for changing your password.
There is no user registered with this email.
Sign Up
To create a free account, please fill out the form below.
Thank you for signing up!
A confirmation email has been sent to your email address. Please check your email and follow the instructions in the message to complete the registration process. If you do not receive the email, please check your spam folder or contact us for assistance.
Welcome to our platform!
Oops!
Something went wrong while trying to create your new account. Please try again and if the problem persist, Email Us to receive support.
Guided Therapeutics (GTHP) has commenced patient enrollment and testing for its LuViva Advanced Cervical Scan at the Department of Obstetrics & Gynecology Hospital of Fudan University in Shanghai. This pivotal clinical trial is integral to the company's international commercialization strategy. Upon submission of data to the Chinese NMPA, GTHP is set to receive $620,000 from its partner, Shandong Yaohua Medical Instrument Corporation, with an additional $1.88 million due post-marketing approval. Cervical cancer remains a critical health issue in China, with the LuViva device providing timely screening benefits.
Positive
Commencement of pivotal clinical trial for LuViva in China.
Expected $620,000 payment upon data submission to NMPA.
Potential additional $1.88 million due after marketing approval.
Device well-suited for cervical cancer screening in rural areas.
Negative
Dependence on regulatory approval from NMPA for market entry.
Potential risks associated with early-stage commercialization.
PEACHTREE CORNERS, Ga.--(BUSINESS WIRE)--
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, announced today that enrollment and testing of patients has begun at the Department of Obstetrics & Gynecology Hospital of Fudan University located in Shanghai.
The data will be submitted to the Chinese National Medical Products Administration (NMPA; formerly known as the Chinese FDA). Upon such submission, $620,000 is due to Guided Therapeutics from the Company’s Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI). The balance of the $2.5 million purchase order from SMI (i.e., $1,880,000) will be due and payable upon marketing approval from NMPA.
“Starting the pivotal clinical trial in China is a key milestone in our international commercialization strategy,” said Gene Cartwright, CEO of Guided Therapeutics. “The study is very reasonable in terms of number of women to be tested and it is a pleasure to be working with thought leaders in the Chinese Gynecological and Obstetrics community.”
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.
What is the significance of the clinical trial started by Guided Therapeutics in China?
The clinical trial for LuViva is crucial for international commercialization and aims to address cervical cancer screening in China, a country with high incidence rates.
How much funding is Guided Therapeutics expecting from its Chinese partner?
Guided Therapeutics expects to receive $620,000 upon submission of trial data to the Chinese NMPA, with an additional $1.88 million due after receiving marketing approval.
What are the implications of the cervical cancer statistics in China for Guided Therapeutics?
With approximately 100,000 new cervical cancer cases annually in China, the need for effective screening solutions like LuViva presents a significant market opportunity for Guided Therapeutics.
What challenges could Guided Therapeutics face in the clinical trial process?
Challenges include regulatory approval from the NMPA and uncertainties associated with product market acceptance and commercialization.
