Mar 29 2014
Guided Therapeutics, Inc. today announced that the company has submitted a letter requesting a face-to-face meeting with the U.S. Food and Drug Administration (FDA) in the next 60 to 90 days. This letter is in response to the September 6, 2013 letter that the company received from the FDA. Additionally, the FDA has granted the company its requested 180 day extension on the PMA filing to allow time for the meeting to occur.
“While we have drafted our responses to questions in the not approvable letter received in September, we feel it is in our best interest to meet with FDA before submission of the official response,” said Gene Cartwright, Chief Executive Officer of Guided Therapeutics. “These face-to-face meetings are an important part of advancing the approval process. The extension we received on March 18 will enable both the company and FDA to prepare adequately in order to make the most of the meeting.”
“While focusing on growing sales for our product in places like Canada, Turkey, Europe and Africa, we remain confident in the potential of LuViva in the U.S. market and remain committed to pursuing FDA approval,” Mr. Cartwright said.
The company has regulatory approval to sell LuViva in Europe with the Edition 3 CE mark, has marketing approvals from Health Canada and Singapore Health Sciences Authority and has filed for approval in Mexico. Additionally, expansion efforts are ongoing in the Middle East, Asia, Africa and Latin America.
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.
Source: http://www.guidedinc.com/