Georgia medical device maker Guided Therapeutics (OTC:GTHP) dropped hard today after announcing that FDA regulators are still not satisfied with the company’s pre-market approval application for the LuViva advanced cervical scanner.
News of the latest setback sent GTHP shares down more than 18% mid-morning, when they were trading at about 55¢ apiece as of about 11:40 a.m.
The company has for months been working with the federal watchdog agency to revamp its once-rejected PMA bid, but the FDA has new questions about LuViva according to a letter issued to the company late last week. The new queries add to more than 100 questions already answered about the scanning technology, according to a company statement.
The FDA in January refused Guided Therapeutics’ original PMA bid, asking that the company provide additional data on a newer version of the device and make some changes to the study parameters. The company made some progress with regulators and in July 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 is now looking for details on LuViva’s cleaning and disinfection system, it’s optics and it’s analytical capabilities for specific patient groups. The agency’s response was "disappointing" for Guided Therapeutics president & CEO Mark Faupel, he said in prepared remarks, but the company remains bullish about its prospects.
"We continue to believe that the U.S. will be a viable market for the product and that we will ultimately receive home country approval," Faupel said. "At the same time, we also believe that the international market provides tremendous opportunity for growth."
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 is preparing regulatory filings for Mexico, and is "aggressively" expanding in the Middle East, Asia, Africa and Latin America, Faupel said.
