Guided Therapeutics (OTC:GTHP) made new progress on its once-rejected pre-market approval bid for the LuViva advanced cervical cancer scanning system, which the FDA knocked with a "not approvable" letter in January.
The medical device company met with the FDA earlier this month to develop a path forward to pre-market approval for LuViva, a non-invasive scanning system designed to detect disease that leads to cervical cancer.
The FDA in January refused Guided Therapeutics’ original PMA bid, asking that the company provide additional data on a newer version of the device and make some changes to the study parameters.
"We are disappointed that the FDA has issued a not-approvable letter after previously telling the company that a panel review of LuViva would not be necessary since the agency understood LuViva’s technology, it understood the clinical application and had also reviewed similar devices in the past," Faupel said at the time. "As to the request for additional clinical data, we believe that we’ve already addressed this point effectively and that we have proven the device’s accuracy in studies involving more than 3,000 women with no adverse events. The other items in the letter, such as a new request for outlining and testing a cleaning procedure, will be addressed routinely."
Guided Therapeutics in turn called for an independent panel audit of the of the PMA decision and announced that it would press forward with approval bids is Europe and Asia.
The company just about a week ago announced a win in Europe with CE Mark approval for LuViva, the 1st of 2 CE Mark hurdles the company must meet before reaching full compliance with European regulations. Guided Therapeutics expects to file the 2nd CE Mark later this year, according to a press release.
The new pre-market approval progress plan calls for the device maker to use existing clinical data to answer questions raised in the January letter, according to a press release.
"We are pleased with both the tenor and substance of the meeting with FDA and believe we have a good plan to move the PMA process forward through what we hope will be a quick review and approval for LuViva," president & CEO Mark Faupel said in prepared remarks. "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, and providing women and doctors the first test with instant results."