Guided Therapeutics pushes LuViva PMA bid

Guided Therapeutics (OTC:GTHP) said today that it pushed its bid for pre-market approval for its LuViva from the FDA, after the U.S. safety watchdog handed it another setback last spring.

GTHP shares lost ⅓ of their value May 20 after the FDA asked Norcross, Ga.-based Guided Therapeutics for more data on the LuViva device, which is designed to scan the cervix for chemical and structural indicators of pre-cancerous tissue.

Today 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.

Guided Therapeutics said it also asked for a face-to-face sitdown with the FDA in hopes of convincing it to approve the study design.

“As we finalize our plan for working with the FDA towards approval and entry into the U.S. market, our major corporate focus has been to grow international sales in markets where LuViva can be used as the primary screening test,” CEO Gene Cartwright said in prepared remarks. “For example, we recently achieved a major milestone with the announcement of a $10 million order for the Turkish Ministry of Health, and we continue to work with other governments to include LuViva in their national cervical cancer screening programs.

“In the meantime, we will continue to pursue FDA approval and believe that the plan we put forth to the FDA is solid, addresses the agency’s additional questions and will lead to approval,” Cartwright added.

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.

Cartwright has said the company is confident in an eventual PMA nod. LuViva is already approved under a CE Mark in the European Union and has similar OKs in Mexico, Canada and Singapore, among other jurisdictions, Guided Therapeutics said.

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