Guided Therapeutics sees FDA path for LuViva cervical scanner

Guided Therapeutics (OTC:GTHP) said today that it believes it struck a “general agreement” for getting its LuViva cervical scanner approved by the FDA.

The plan to collect more data on LuViva is slated to be completed over the next 2 to 3 months, Norcross, Ga.-based Guided Therapeutics said. The company said the agreement was hashed out at a meeting with the FDA and 2 U.S. obstetric-gynecologists, including a new lead reviewer at the federal safety watchdog and a new OB-GYN doc.

“The objectives of the meeting were certainly met and we were pleased that the [FDA’s] division director and two deputy directors participated. We look forward to working with the new lead reviewer and lead OB-GYN physician to obtain U.S. approval for LuViva,” CEO Gene Cartwright said in prepared remarks. “We expect to have the details of the plan worked out with the agency over the next 2 to 3 months, which will include submitting a clinical protocol for collecting the additional patient data. Once the protocol is finalized, we will conduct the study, analyze the data and present the results to the agency for review, a timeline that entails at least a year before possible approval.”

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

Guided Therapeutics 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.

The company 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 Guided Therapeutics took another shot at the U.S. market, nearly a year after receiving the 2nd non-approvable letter for the LuViva device.

LuViva has CE Mark approval in the European Union and approvals in Canada and Mexico, Guided Therapeutics said. The device is on the market in 20 countries, the company said.

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