Guided Therapeutics (OTC:GTHP) said it closed the sale of 4 million shares of stock to Chinese investors worth up to $775,000 as it eyes a distribution deal for its LuViva device in the People’s Republic.
Norcross, Ga.-based Guided Therapeutics said it inked a letter of intent to negotiate the exclusive distribution rights for LuViva in China. The device is designed to scan the cervix for chemical and structural indicators of pre-cancerous tissue.
Guided Therapeutics said it sold 4 million shares, plus warrants for another 2 million, for $720,000. The LOI calls for the sale of 5 LuViva devices in Hong Kong and China, with shipment of the 1st 2 devices triggered by a $55,000 payment.
"China is a top market opportunity for LuViva as both a triage product to reduce unnecessary biopsies after a positive Pap result and also as a point-of-care, primary screening tool for cervical cancer. The investors have strong ties to the largest private hospital in China, as well as one of the country’s largest medical technology companies that has built a very successful business delivering advanced healthcare in China," president & CEO Gene Cartwright said in prepared remarks.
The company is waiting for the FDA’s response to its amended pre-market approval application after a pair of failed approval bids. 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.
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.
In February Guided Therapeutics said it hoped to hear from the safety watchdog "within the next several weeks."
"With regard to our progress toward FDA approval of LuViva, we have been told by the FDA that an amended PMA application is not held to the same timeline performance standards as an initial filing. The FDA has attributed its delay primarily due to other regulatory priorities, including some nationwide issues that have demanded the FDA’s attention. We continue to be in regular contact with our consultants and the FDA, and have been assured that the FDA will respond to our amended PMA application shortly," Cartwright said in prepared remarks.
