Guided Therapeutics (OTC:GTHP) said today it launched its LuViva cervical scanning system in Costa Rica, despite continued struggles to get the device approved in the U.S.
A Costa Rican pilot program using LuViva, which is designed to scan the cervix for chemical and structural indicators of pre-cancerous tissue, is slated to begin in the coming weeks, the Norcross, Ga-based company said.
“We are pleased to see our growing traction among doctors, governments and distributors in the developing world as stakeholders increasingly recognize that LuViva can help prevent women’s cervical cancer through earlier detection. We will continue to focus on new markets, like Costa Rica and others, where LuViva will be used as a front line screener for cervical cancer,” CEO Gene Cartwright said in a press release.
Guided Therapeutics is still fighting what has been an uphill battle to get the device cleared by the FDA. 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.
This year in May, the medical device company revealed another setback in a 3rd non-approvable letter from the FDA. Guided Therapeutics said the federal safety watchdog wanted more data on the LuViva device, and “also stated its willingness to consider alternative approaches to move the product to approvable form.”
GTHP shares lost ⅓ of their value May 20 after the FDA asked Guided Therapeutics for more data on the LuViva device.
Last week, the company said it agreed to an FDA request for more scans on patients using new cervical cancer screening guidelines and proposed a “confirmatory” study to generate supplemental data in a pre-submission letter to the agency.