Guided Therapeutics, Inc., (OTCBB: GTHP) (OTCQB: GTHP), today announced that it has submitted its premarket approval (PMA) Amendment for the LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease that leads to cancer, instantly and at the point of care.
The amendment is in response to a "not approvable" letter received by the company in January and includes additional data analysis requested by the U.S. Food and Drug Administration (FDA).
"We are pleased to move the FDA review process forward with the filing of the amended PMA for LuViva," said Mark L. Faupel, Ph.D., President and CEO of Guided Therapeutics. "We have worked with the agency over the last several months to provide responses to the key questions in the PMA amendment and are hopeful this filing will ultimately lead to approval for the product. We believe that once approved, LuViva will have a very positive impact on the U.S. healthcare system by improving the standard of care for the early detection of cervical disease, providing women and doctors with the first test with instant results and detecting cervical disease at an earlier stage, when it can be better treated."
LuViva has been under FDA PMA review since September 23, 2010. The company received a "not approvable" letter for the product on January 20, 2012. In July, 2012 the company met with the agency and agreed to file a PMA amendment to address the agency's questions stemming from the "not approvable" letter. With the PMA amendment now formally submitted, the FDA has 180 days during which it can respond.
LuViva currently has marketing approval from Health Canada and received its first CE Mark, an ISO 60601 Edition 2 Notification, in July. The company is in the process of testing the LuViva system for compliance with the Edition 3 CE Mark requirements, which the company expects to achieve near the end of this year. Guided Therapeutics was awarded ISO 13485 certification in January, 2011.
Guided Therapeutics, Inc.