Norcross, Ga.-based Guided Therapeutics said the federal safety watchdog wants more data on the LuViva device, which is designed to scan the cervix for chemical and structural indicators of pre-cancerous tissue.
Guided Therapeutics said the FDA "also stated its willingness to consider alternative approaches to move the product to approvable form."
Guided Therapeutics 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 the company took another shot at the U.S. market, nearly a year after receiving the 2nd non-approvable letter for the LuViva device.
"We believed our PMA amendment addressed the remaining questions the agency had about our original application," CEO Gene Cartwright said yesterday in prepared remarks. "At the current time, however, we believe the best and fastest way to secure approval may be to collect data on additional subjects and then file an amendment to further demonstrate LuViva’s safety and effectiveness as a triage device after an abnormal HPV test or Pap test. While we are disappointed the data analysis issue was not fully resolved, we are encouraged that no other remaining or new issues were raised in the FDA letter."
GTHP shares were down -33.3% to 11¢ apiece in early afternoon trading today.
Cartwright said the company is confident in an eventual PMA nod. LuViva is already approved under a CE Mark in the European Union and has similar OKs in Mexico, Canada and Singapore, among other jurisdictions, Guided Therapeutics said.