NORCROSS, Ga.--(BUSINESS WIRE)--Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, announced today that it has signed a preliminary license agreement with its Turkish distribution partner ITEM for the manufacture of patented single-patient-use Cervical Guides in Turkey.
In return for the license and manufacturing rights for Cervical Guides in Turkey, GTHP will receive fees totaling $3,000,000 in 2018. In addition, ITEM will pay GTHP a royalty for each Cervical Guide made and sold exclusively in Turkey and ITEM will be obligated to purchase 600 LuViva Advanced Cervical Scans and produce 3 million Cervical Guides for the Turkish market over the next five years.
“ITEM has recently informed us that based on recent clinical studies, including the first published study indicating that LuViva is safe and effective for pregnant women, the Turkish Ministry of Health has approved LuViva for wide scale screening of cervical cancer,” said Gene Cartwright, CEO of Guided Therapeutics, Inc. “Because of this, we now expect a more rapid penetration into the market and increased government reimbursement. These factors are contributing to the feasibility of a license agreement at this point in time.”
ITEM’s President, Zafer Yazici, noted that “ITEM is pleased to be in the forefront of the advance of women’s health in Turkey and to help in the diagnosis and care of cervical cancer by providing such advanced technology and enabling the early detection of this serious disease.”
According to the World Health Organization, cervical cancer is ranked as one of the most frequent cancers in women. Turkey has a population of approximately 26 million women above 15 years of age, who are at risk of developing cervical cancer. The current estimates indicate approximately 5500 new cases diagnosed and 1950 deaths annually in Turkey, making the control of this deadly disease a priority for the Ministry of Health.
About LuViva® Advanced Cervical Scan
The 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 may result in eliminating costly, painful and unnecessary additional testing. LuViva is intended 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. It has also been used in clinical studies in Turkey and Nigeria as a means to screen women for cervical cancer where the availability of infrastructure necessary for Pap and HPV testing is restricted. The device is used in conjunction with the LuViva® Cervical Guide single-use patient interface and calibration disposable.
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, 2016 and subsequent filings.