Guided Therapeutics (OTC:GTHP) saw a little surge in its stock at the end of last week after the company offered some updates on the trials and tribulations of chasing regulatory approval for its LuViva Advanced Cervical Scan.
Guided Therapeutics is still working on an amended submission for FDA review, but the company won approval to sell the device in Mexico, according to a press release. Guided Therapeutics plans to sell the devices through distributor Dantien5 Medical.
Cervical cancer is the leading cause of cancer of women of reproductive age in Mexico, and the 2nd-leading cause of cancer-related deaths, Guided Therapeutics said. Some 36 million women are at risk and more than 13,900 cases are diagnosed every year.
"Cervical cancer is a large problem in Mexico with limited access to health care which contributes to a high national mortality rate. As a result, we are actively working on practical evaluations to expedite availability of this early detection technology to Mexican women," Dantien5 Medical director Carlos Lugo said on behalf of Guided Therapeutics. "After a recent successful meeting with the Principal Investigator at a key facility, we expect the evaluation to begin this quarter."
On the U.S. front, Guided Therapeutics is having slower success in getting LuViva on the market. The company said again this month that it plans to file an amendment to its rejected PMA bid after carefully reviewing minutes from a May meeting with the FDA. The company has also hired on an FDA consultant to review the amendment, saying that it plans to get the final review back this month.
"It is important to have agreement on statements made by FDA during our face-to-face meeting in May," CEO Gene Cartwright said in an SEC filing. "Given the information we currently have, we anticipate filing with the FDA late in July."
GTHP shares closed on Friday at 48.5¢ apiece, up about 1% for the day. The stock has gained 6.6% over the last month.
In January 2013, the FDA refused Guided Therapeutics’ original PMA bid, asking that the company provide additional data on a newer version of the device and make some changes to its study parameters. The company made some progress with regulators and in July 2013 announced that it had an FDA-approved path forward to a PMA for LuViva, a non-invasive scanning system designed to detect disease that leads to cervical cancer.
Last September, Guided Therapeutics revealed that FDA regulators were still not satisfied with its PMA application for LuViva. The company had been working for months with the bureau to revamp its once-rejected PMA bid, but the FDA had new questions about LuViva. The new queries add to more than 100 questions already answered about the scanning technology, Guided Therapeutics said at the time.
