Guided Therapeutics’ LuViva® Advanced Cervical Scan Awarded Mexican Regulatory Approval
Product introduced at Mexico’s leading gynecology meeting
MEXICO CITY--(BUSINESS WIRE)--Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced that LuViva® Advanced Cervical Scan was approved for sale in Mexico by the Federal Commission for Protection against Health Risks (COFEPRIS).
“Approval to sell LuViva in Mexico is a significant milestone for the company and opens up the second largest market for medical products in Latin America”
“Approval to sell LuViva in Mexico is a significant milestone for the company and opens up the second largest market for medical products in Latin America,” said Gene Cartwright, Chief Executive Officer of Guided Therapeutics. “We will be working with Dantien5 Medical, our distributor in Mexico, to promote LuViva for the detection of cervical cancer, a tremendous unmet need in this part of the world.”
Cervical cancer is the leading cause of cancer in women of reproductive age in Mexico, and remains the second leading cause of cancer deaths in women. Each year, more than 13,900 cases of cervical cancer are diagnosed in Mexico, and more than 4,700 women die from the disease. The total population at risk for developing cervical cancer is nearly 36 million (ages 15-55), and cervical cancer remains a national health priority.
“Cervical cancer is a large problem in Mexico with limited access to health care which contributes to a high national mortality rate. As a result, we are actively working on practical evaluations to expedite availability of this early detection technology to Mexican women,” said Carlos Lugo, Director of Dantien5 Medical. “After a recent successful meeting with the Principal Investigator at a key facility, we expect the evaluation to begin this quarter.”
LuViva was recently introduced to Mexican gynecologists at the XIX Congress of the Mexican College of Obstetrics and Gynecology Specialists (COMEGO), in Mexico City. Dr. Carlos Salazar López Ortiz, past president of COMEGO, presented LuViva to approximately 300 gynecologists in a plenary session. As part of the introduction, a LuViva news conference was held that was covered by close to a dozen Mexican media outlets. In addition, a Spanish-language web site was launched at www.luviva.com.mx.
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.
About Guided Therapeutics
Guided Therapeutics, Inc. (OTCBB: GTHP) (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. 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, 2013, and subsequent quarterly reports.