Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) and its Turkish distributor, I.T.E.M. Medical Technologies Group, today announced a major program for early detection and prevention of cervical cancer involving Guided Therapeutics’ LuViva® Advanced Cervical Scan. The program for 2013 and 2104, to be funded by Turkey’s Ministry of Health, would involve the order and placement of up to $3 million worth of LuViva Advanced Cervical Scan devices and associated disposables. In addition, the Ministry of Health will conduct clinical trials to assess the utility of LuViva within a broader national program of cervical cancer control.
“The selection of the LuViva Advanced Cervical Scan for inclusion in Turkey’s cervical cancer prevention program is an honor which speaks to the clinical advantages of our technology, including safety, diagnostic accuracy and economic efficiency,” said Mark L. Faupel, Ph.D., CEO and President of Guided Therapeutics, Inc. “We look forward to working with I.T.E.M. and the Ministry to improve health care for all Turkish women.”
Zafer Yazici, CEO and President of I.T.E.M. Medical Technologies Group, added, “We are pleased to be in a partnership with the Ministry of Health and Guided Therapeutics to bring LuViva into clinical practice for cervical cancer prevention. The program is consistent with our commitment to bring advanced medical technologies to this region of the world. We expect that LuViva's innovative technology will establish Turkey as a leader in cancer control strategies, while raising the bar in women's healthcare."
Under terms of the program, initial shipments are expected to begin this quarter and last through the end of 2014.
Each year in Turkey, about two million women undergo Pap test screening for cervical cancer, with as many as 200,000 receiving an abnormal Pap result. Recently, human papillomavirus (HPV) screening for women was introduced as an alternative to Pap testing. Women who demonstrate either an abnormal Pap or Positive HPV test are then scheduled for a follow-up exam, called a colposcopy, which typically includes a painful biopsy of cervical tissue. LuViva is designed to be used before colposcopy to identify women without disease and prevent them from receiving unnecessary biopsies. Besides the obvious reduction in patient discomfort, there is also expected to be a reduction in healthcare costs. All of this is accomplished utilizing a painless test that takes about one minute and produces a result immediately at the point of care.
About LuViva® Advanced Cervical Scan
LuViva is a technologically advanced diagnostic device that scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue. Spectroscopy identifies chemical and structural indicators of precancer that may be below the surface of the cervix or misdiagnosed as benign. This technique is called biophotonics. Unlike Pap, HPV tests or biopsies, LuViva does not require laboratory analysis or a tissue sample, and is designed to provide results immediately, which eliminates costly, painful and unnecessary testing. LuViva is designed for use with women who have undergone initial screening and are called back for follow up with a colposcopy examination, which in many cases involves taking a biopsy of the cervix. The device is used in conjunction with the LuViva® Cervical Guide single-use, patient interface and calibration disposable.
The LuViva Advanced Cervical Scan is compliant with both Edition 2 and Edition 3 CE standards, has marketing approval from Health Canada and the Singapore Health Sciences Authority, and is under U.S. Food and Drug Administration Premarket review.
About I.T.E.M. Medical Technologies Group
I.T.E.M Innovations Group is a leading medical technology consortium in Turkey. The companies within the I.T.E.M. Group include ROTA ILERI CO. LTD. and NOVATEK CO. LTD., which were established in 1990 and have successfully introduced an impressive number of innovative medical technologies to the market. I.T.E.M Innovations Group has been one of the most dynamic, fast growing and trustworthy medical companies in the region for more than 20 years.
About Guided Therapeutics
Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) is developing a rapid and painless testing platform for the early detection of disease based on its patented biophotonic technology that utilizes light to detect 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. Guided Therapeutics is also developing a non-invasive test for the early detection of esophageal cancer using the technology platform. 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. 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 products in development, 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 uncertainty of capital to develop products, the uncertainty of regulatory approval of products, 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, 2012, and subsequent quarterly reports.
Alison Ziegler, 212-554-5469
Guided Therapeutics, Inc.
Bill Wells, 770-242-8723, ext. 241