|The FDA has more questions over Guided Therapeutics' LuViva device.--Courtesy of Guided Therapeutics|
The FDA dealt Guided Therapeutics ($GTHP) its second "not approvable" letter in 18 months, asking more questions about a cervical scanning device the company submitted for review in 2010.
In the latest regulatory problem for the LuViva Advanced Cervical Scan, the FDA wants new analysis of the device's clinical data and more information on disinfection of the scanner and its optics, according to the company. Guided Therapeutics said it has on-hand information to answer the cleaning and optical questions and will work with the agency on any clinical issues, but the company isn't providing a timeline for approval.
Guided Therapeutics received its first FDA rebuff in January 2012, when the agency had questions about LuViva's clinical data and how the company analyzed it. That summer, Guided Therapeutics said it had a productive meeting with the FDA in which it identified a path to approval. That, apparently, didn't work out.
"While we are disappointed with the FDA's latest response, we feel we have made progress by responding to more than 100 questions during the review process," CEO Mark Faupel said in a statement. "We continue to believe that the U.S. will be a viable market for the product and that we will ultimately receive home country approval. At the same time, we also believe that the international market provides tremendous opportunity for growth."
The device, designed to detect cervical disease that can lead to cancer, is already approved in Europe, Canada and Singapore, Guided Therapeutics said, and the company is in the process of applying for Mexican approval and expanding its sales presence in the Middle East, Asia, Africa and Latin America.
- read the statement