Guided Therapeutics (OTC:GTHP) is getting its requested date with the FDA’s medical device regulators, during which the company hopes to revive its rejected bid to win approval for the LuViva cervical scanner.
The meeting, set to take place May 8, comes after the FDA in September 2013 issued a non-approvable letter on the LuViva device. The FDA said at the time that it had additional questions about LuViva, asking Guided Therapeutics to provide details on LuViva’s cleaning and disinfection system, its optics and its analytical capabilities for specific patient groups.
The FDA ultimately granted Guided Therapeutics a 180-day extension on the premarket approval application and last month the company announced that it would seek an in-person meeting with regulators.
"These face-to-face meetings are an important part of advancing the review process and we are pleased that the FDA has responded so quickly to our request for the meeting," Guided Therapeutics CEO Gene Cartwright said in prepared remarks. "After the meeting, we plan to submit our formal, written response to questions in the September 6, 2013 letter."
In the mean time, the device maker is focusing on sales efforts internationally. The LuViva scanner has approval from regulators in Europe, Canada and Singapore, and Guided Therapeutics is also pursuing approval in Mexico. Additional expansion efforts are underway for the Middle East, Asia, Africa and Latin America, the company said.
GTHP shares were trading 2% higher yesterday, going for about 49¢ apiece as of about 4 p.m. EST.