Guided Therapeutics’ Announces Data from Chinese NMPA Clinical Study Signed Off by All Four Clinical Sites With Better Than Expected Results
July 10 2024 - 8:30AM
Business Wire
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva
Advanced Cervical Scan, announced today that leading physicians
from four prestigious medical centers have completed their review
and signed off on the study results for submission to the Chinese
National Medical Products Administration (NMPA). Approximately 460
women were tested with LuViva at four leading hospitals in China.
There were no adverse events reported with the use of LuViva during
the study, proving once again that LuViva is safe when used as
directed. The study was led by Professor Dr. Kong Beihua of Qilu
Hospital at Shandong University and Dr. Sui Long, Director of the
Gynecology Hospital at Fudan University. Professor Kong is the
current Vice Chairman of the Chinese Society of Obstetrics and
Gynecology Society. Dr. Sui has summarized the results of the four
clinics and his report, along with other information required by
NMPA, is expected to be filed within the next four to five weeks.
While the actual results in terms of test accuracy will be known
when filed with NMPA, the physicians who reviewed and compiled the
data believe the results are “well above that expected by NMPA” and
therefore “are expected to result in approval of LuViva for sale in
China.”
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, 2023 and subsequent
filings.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240710088176/en/
Mark Faupel Guided Therapeutics 770-242-8723