PEACHTREE CORNERS, Ga.--(BUSINESS WIRE)--Guided Therapeutics, Inc. (Pink Sheets: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, announced that its flagship product, the LuViva Advanced Cervical Scan, had received a new CE Mark through its European contract manufacturer, Newmars Technologies, Kft. (Budapest, Hungary). As a part of this process, Newmars Technologies’ quality system passed the new, more rigorous ISO 13485:2016 standard for medical devices. In addition to the CE Mark, the new ISO certification is an important milestone, as it is becoming the de facto quality system standard around the world, including for the U.S. FDA.
“We are extremely pleased to have been able to work with Newmars Technologies in completing this major milestone. The CE Mark enables expanded commercialization of LuViva in 27 EU-associated countries totaling a population of 229 million women. It also is the accepted standard used by many other countries around the world,” said Gene Cartwright, Guided Therapeutics CEO.
The new CE Mark includes expanded claims for the use of LuViva by physicians for the early detection of cervical cancer. According to the clinical studies included in the CE Mark application and reviewed by the CE authorities, LuViva can now be used as an alternative to traditional screening methods, especially in localities or countries where cervical cancer screening programs are unavailable or underutilized because of a lack of laboratory infrastructure or other limitations. LuViva has previously been approved for cervical cancer screening in countries as diverse as Indonesia, Kenya and Costa Rica. The screening indication for use is in addition to LuViva’s previous indication for use as a secondary screener for assessing the risk of cervical disease in women who screen positive on traditional screening tests such as the Pap smear. As opposed to the Pap smear and Human Papilloma Virus test, LuViva does not require a laboratory infrastructure for processing a sample and produces an immediate result at the point of care, so that treatment can begin sooner.
“Achieving the CE Mark with expanded claims for screening will be a significant boost in our efforts to market LuViva in the Central and Eastern European countries we plan to launch in this year,” said Karoly Majoros, CEO of Newmars Technologies. “We look forward to working with Guided Therapeutics to bring enhanced detection of cervical of cancer at its earliest stages, when it is most treatable.”
According to the World Health Organization, cervical cancer is ranked as the fourth most common type of cancer in women worldwide, with approximately 700,000 cases reported annually. Because cervical cancer often is detected too late, it is one of the leading causes of cancer-related female death in developing countries, with 311,000 women lost each year.
About Guided Therapeutics
Guided Therapeutics, Inc. (Pink Sheets: 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.
About Newmars Technologies
Newmars Technologies is focused on the production and sales of medical devices that utilize unique know-how. We bring to the medical market advanced technologies which allows both doctors and patients access to advanced technology that promotes a healthful life. Located in the heart of Europe, Newmars is ISO 13485:2016 compliant and delivers medical equipment to its customers using advanced logistics combined with technical and marketing support.
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, 2019 and subsequent filings.