Guided Therapeutics (OTC:GTHP) said it’s asked the FDA for a face-to-face meeting as it tries to resurrect the pre-market approval application for its LuViva cervical scanning device.
Norcross, Ga.-based Guided Therapeutics said it wants the sit-down to happen in the next 60 to 90 days so it can discuss the issues raised in a non-approvable letter the FDA issued last year. The federal watchdog agency granted a 180-day extension on the PMA filing, the company said.
"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," CEO Gene Cartwright said in prepared remarks. "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."
Last September, Guided Therapeutics revealed that FDA regulators were still not satisfied with its PMA application for the LuViva advanced cervical scanner. The company had been working for months with the bureau to revamp its once-rejected PMA bid, but the FDA had new questions about LuViva. The new queries add to more than 100 questions already answered about the scanning technology, Guided Therapeutics said at the time.
In January 2013, the FDA refused Guided Therapeutics’ original PMA bid, asking that the company provide additional data on a newer version of the device and make some changes to the study parameters. The company made some progress with regulators and in July 2013 announced that it had an FDA-approved path forward to a PMA for LuViva, a non-invasive scanning system designed to detect disease that leads to cervical cancer.
The FDA wants details on LuViva’s cleaning and disinfection system, its optics and its analytical capabilities for specific patient groups. Guided Therapeutics is still fighting the regulatory battle in the U.S., but LuViva is already on the market internationally. The company has CE Mark approval for the European Union as well as regulatory OKs in Canada and Singapore. Guided Therapeutics has filed for approval for LuViva in Mexico, the company said today, adding that "expansion efforts are ongoing in the Middle East, Asia, Africa and Latin America."
Guided Therapeutics named Cartwright its new CEO last month, replacing former CEO Mark Faupel who, was named chief scientific officer.