Guided Therapeutics (OTC:GTHP) said today that it won a date with the FDA to discuss its stalled bid for pre-market approval for the LuViva cervical scan device.
Norcross, Ga.-based Guided Therapeutics said it’s slated to meet Nov. 6 with the FDA 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.
Today the company said the FDA also named a new lead reviewer to oversee the PMA review of LuViva.
“We look forward to working with FDA and our new lead reviewer in order to achieve U.S. approval for LuViva,” CEO Gene Cartwright said in prepared remarks. “Meanwhile, we are working with governments of several countries outside the U.S. to make the LuViva the standard of care for women’s health.”
