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 definitive, multiyear license agreement with its Turkish distribution partner ITEM for the manufacture of patented single-patient-use Cervical Guides in Turkey. The production of Cervical Guides in Turkey exclusively for the Turkish market was recommended by the Turkish Ministry of Health to speed adoption of the technology in Turkey.
“This watershed agreement has the potential to help redefine cervical cancer screening in the 21st century by applying brand new technology to a pervasive and largely unmet need in most countries”
In return for the license and manufacturing rights for Cervical Guides in Turkey, the agreement calls for GTHP to receive fees totaling $1,100,000 in 2018, with the first payment due by April 15. In addition, according to the contract, ITEM will pay GTHP a royalty for each Cervical Guide made and sold exclusively in Turkey and ITEM will be obligated to purchase 540 LuViva Advanced Cervical Scans and produce 3,450,000 Cervical Guides for the Turkish market over the next twelve years. The expected minimum revenues for Guided Therapeutics over the twelve-year length of the contract will be approximately $19.4 million, roughly half of which will be product sales and the other half royalty payments, according to the agreement.
“This watershed agreement has the potential to help redefine cervical cancer screening in the 21st century by applying brand new technology to a pervasive and largely unmet need in most countries,” said Gene Cartwright, CEO of Guided Therapeutics, Inc. “We look forward to continuing to work with ITEM and the Turkish Ministry of Health to bring LuViva to the women of Turkey.”
ITEM’s President, Zafer Yazici, noted that “The clinical value of LuViva as a primary screening test has been demonstrated in Turkey in several studies conducted by thought leaders in the medical community. Now we must work diligently with the Ministry, hospitals, clinics and physicians to realize the potential of this technology and set an example for other countries in need of improved screening.”
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.