Guided Therapeutics, Inc. today announced that the company received additional questions from the U.S. Food and Drug Administration (FDA) regarding the pre-market approval application for the LuViva ® Advanced Cervical Scan. FDA advised the company the PMA was not yet approvable in its current form and that the company needed to address these questions in order to place the PMA in approvable form.
The new questions, received in a letter dated September 6, 2013, pertain to the cleaning and disinfection of the LuViva device, the optics of the system and a new analysis on specific subsets of the patient population. The company believes it has on hand information to successfully answer the cleaning and optical questions and plans to work with FDA to resolve any remaining questions pertaining to the analysis of the clinical data.
While the company plans to work with FDA to address the outstanding issues, it is also focused on its international launch of LuViva, with a meeting later this week with the Ministry of Health in Mexico in conjunction with our current distribution partner, the placement of devices with the Ministry of Health in Turkey and in servicing of devices in Canada, Africa and Europe.
"While we are disappointed with the FDA’s latest response, we feel we have made progress by responding to more than 100 questions during the review process,” said Mark L. Faupel, president and CEO of Guided Therapeutics. “We continue to believe that the U.S. will be a viable market for the product and that we will ultimately receive home country approval. At the same time, we also believe that the international market provides tremendous opportunity for growth.” “We have received regulatory approval to sell LuViva in Europe with the Edition 3 CE mark, and marketing approvals from Health Canada and Singapore Health Sciences Authority and are in the process of filing for approval in Mexico,” said Dr. Faupel. “Additionally, we continue to aggressively expand our markets 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.
Guided Therapeutics will hold a conference call at 9:00 a.m. EDT on Monday, September 9, 2013, to discuss the FDA response. Interested parties are invited to listen to the call live over the Internet at http://www.guidedinc.com/investors.htm or http://www.viavid.net. The live call will also be available by dialing (888) 287-5563 or for international callers (719) 457-2727 and referencing Conference ID 9006702.
A replay of the teleconference will be available on http://www.guidedinc.com/investors.htm. A replay will also be available until September 16, 2013 by dialing (877) 870-5176 or for international callers (858) 384-5517, and using pin number 9006702.