The Norcross, Ga.-based company said it received the request as a “new communication regarding regulatory approval of its LuViva line of products in China,” adding that it plans to submit final paperwork for approval following completion of the trial.
Guided Therapeutics said it plans to run a small trial of 60 to 120 patients at two hospitals in the region. The company expects to launch the trial this summer and complete it within three months.
The company added that its distributor Shangdong Yaouhuo Medical Device Technology Company inked a few new sub-distributors in China and that it revised its forecast for the next year to include orders of 300 LuViva devices and 3 million disposable cervical guides.
“Significant progress is being made on both the regulatory and commercial fronts for LuViva in China, which is likely our largest market given the size of the population and clinical need. We look forward to working with Shandong and the Chinese FDA to bring better healthcare to the women of this vast and important country,” CEO Gene Cartwright said in a press release.
In March, Guided Therapeutics said that it pulled the trigger on a 1 for 800 reverse split of its stock, effective March 29.