Guided Therapeutics Announces Testing Completion of First 150 Patients in Chinese Clinical Study and Receives Milestone Payment of $177,740

Rhea-AI Summary

Guided Therapeutics (OTCQB: GTHP) has completed patient testing for its LuViva Advanced Cervical Scan in a clinical trial seeking NMPA approval in China. The trial, conducted at four sites, involved 150 patients and is expected to conclude in Q2 2023 for subsequent submission. The company received a milestone payment of $177,740 from its partner SMI, which will help supply LuViva devices. Preliminary results indicate good safety and accuracy, supporting the trial's continuation and the upcoming submission.

Positive

• Completion of testing on 150 patients in the NMPA approval trial.
• Received $177,740 milestone payment from Shandong Yaohua Medical Instrument Corporation.
• Preliminary results indicate good safety and accuracy of LuViva.

Negative

• None.

PEACHTREE CORNERS, Ga.--(BUSINESS WIRE)-- Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, announced today that testing of 150 patients has been completed in the ongoing clinical trial for Chinese National Medical Products Administration (NMPA) approval. The trial is underway at four sites in China. The trial is expected to be completed in the second quarter of this year and submitted for approval shortly thereafter.

In addition, the Company’s Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI), made a scheduled milestone payment to the Company of $177,740. A portion of these funds will be used to supply SMI with LuViva devices and parts. According to SMI, both the interim safety and accuracy results of LuViva justify the completion of the clinical study and submission of the data to the NMPA as soon as practicable.

“We are pleased to hear that LuViva has performed well and as expected in the first clinical trials in China,” said Gene Cartwright, CEO of Guided Therapeutics. “We look forward to a speedy conclusion and filing of study results with the Chinese regulatory authorities.”

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220331005134/en/

Mark Faupel

Guided Therapeutics

770-242-8723

Source: Guided Therapeutics, Inc.

FAQ

What is the purpose of the GTHP clinical trial in China?

The clinical trial for GTHP's LuViva Advanced Cervical Scan aims to achieve NMPA approval for the device in China.

What were the results of the LuViva trial?

Preliminary results from the trial show good safety and accuracy, justifying the continuation of the study.

When is the GTHP clinical trial expected to conclude?

The trial is expected to be completed in the second quarter of 2023.

What financial milestone did GTHP achieve recently?

Guided Therapeutics received a milestone payment of $177,740 from Shandong Yaohua Medical Instrument Corporation.