|Guided Therapeutics Provides Update on PMA Application for LuViva® Advanced Cervical Scan and Timing for Filing of CE MarkCompany to Host Conference Call with Investors on January 23 at 10 A.M. EST|
NORCROSS, Ga.--(BUSINESS WIRE)-- Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP) today announced that the company plans to seek an independent panel review of its Pre-market Approval (PMA) application for the LuViva® Advanced Cervical Scan from the U.S. Food and Drug Administration (FDA) after receiving a not-approvable letter from the agency. Meanwhile, the company plans to work with FDA to address the outstanding issues so that they can be successfully resolved.
The Company also announced that it plans to move forward with international sales of Luviva and imminently file for CE mark approval.
"We are disappointed that the FDA has issued a not-approvable letter after previously telling the company that a panel review of LuViva would not be necessary since the agency understood LuViva’s technology, it understood the clinical application and had also reviewed similar devices in the past,” said Mark L. Faupel, Ph.D., president and CEO of Guided Therapeutics. "Similar to the two most recent spectroscopy cancer diagnostic products approved by FDA after first receiving not-approvable letters, we plan on seeking a panel review in order to be granted approval.”
“The company plans to focus more on European and Asian regulatory approvals, while continuing to aggressively pursue approval in the U.S.,” said Dr. Faupel. “With the imminent filing of the CE mark, sales should begin in Europe in the second half of 2012. Based on initial agreements with distributors and the national healthcare structure of medicine in many overseas countries, we believe LuViva would likely be utilized in many institutions more focused on Pap test follow up. Therefore, we would expect that a greater percentage of international sales will come from high margin disposables. As a result of this sales mix, and the lower capital requirements for a launch outside the U.S., our path to breakeven is expected to come as early as 2013, sooner than if we had also initiated marketing in the U.S. this year.”
“In the meantime, our clinical trial data system, two of our clinical trial sites and one of our major suppliers has already undergone successful FDA audits and we will continue working with the agency on a path to approval,” said Dr. Faupel.
LuViva was awarded marketing approval for Canada in December, 2011 by Health Canada. Also in December, LuViva was selected by the National Cancer Institute as one of the agency’s successful investments for developing innovative products to fight cancer.
Conference Call Information
Guided Therapeutics will host a conference call at 10 a.m. EST on Monday, January 23, 2012, to discuss the FDA’s response. Interested parties are invited to listen to the call live over the Internet at us.lrd.yahoo.com**http%3A//cts.businesswire.com/ct/CT%3Fid=smartlink%26url=http%253A%252F%252Fwww.guidedinc.com%252Finvestors.htm%26esheet=50141003%26lan=en-US%26anchor=http%253A%252F%252Fwww.guidedinc.com%252Finvestors.htm%26index=1%26md5=b7991bc4beb0e6149edc46e1503fa990 or us.lrd.yahoo.com**http%3A//cts.businesswire.com/ct/CT%3Fid=smartlink%26url=http%253A%252F%252Fwww.viavid.net%26esheet=50141003%26lan=en-US%26anchor=http%253A%252F%252Fwww.viavid.net%26index=2%26md5=9137407cbf07296d1dacf4765d8a24d6. The live call is also available by dialing (888) 569-5033 or for international callers (719) 457-2647.
A replay of the teleconference will be available on us.lrd.yahoo.com**http%3A//cts.businesswire.com/ct/CT%3Fid=smartlink%26url=http%253A%252F%252Fwww.guidedinc.com%252Finvestors.htm%26esheet=50141003%26lan=en-US%26anchor=http%253A%252F%252Fwww.guidedinc.com%252Finvestors.htm%26index=3%26md5=e1a9a15c6f0104034bf4f452fc535b9f. A replay will also be available until January 30, 2012 by dialing (877) 870-5176 or (858) 384-5517, and using pin number 4235585.