Guided Therapeutics pushes back FDA date for LuViva device

Guided Therapeutics (OTC:GTHP) said today the FDA granted a request to reschedule a meeting to discuss its stalled bid for pre-market approval for its LuViva cervical scan device.

Norcross, Ga.-based Guided Therapeutics said it’s now scheduled to meet with the FDA on Nov. 30 to discuss its plans to submit the application for the cervical scan device. The company rescheduled the meeting to accommodate the schedules of 2 principal investigators in a clinical trial of the device.

“We appreciate the agency working with us to accommodate the busy schedules of Drs. Ferris and Twiggs. Having them both at the meeting will make it more productive and hopefully lead to the most positive outcome,” CEO Gene Cartwright said in a press release.

In September, Guided Therapeutics won a date with the FDA, scheduled for Nov. 6th, to review its proposal for new clinical data on the LuViva device.

GTHP shares lost ⅓ of their value May 20 after the FDA asked the company for more data on LuViva, which is designed to scan the cervix for chemical and structural indicators of pre-cancerous tissue.

Guided Therapeutics agreed to an FDA request for more scans on patients using new cervical cancer screening guidelines and proposed a “confirmatory” study to generate supplemental data.

The company was 1st rebuffed in January 2013 when the FDA refused its original PMA bid, asking for additional data on updates to the device and changes to clinical trial parameters. In July 2013 the company said it had an FDA-approved path to a PMA, but by September of that year FDA regulators were still not satisfied with the amended application. Last July Guided Therapeutics took another shot at the U.S. market, nearly a year after receiving the 2nd non-approvable letter for the LuViva device.

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