WIRE)–Guided Therapeutics, Inc. 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 LuVivas
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
agencys successful investments for developing innovative products to fight
Conference Call Information
Guided Therapeutics will host a conference call at 10 a.m. EST on Monday,
January 23, 2012, to discuss the FDAs response. Interested parties are invited
to listen to the call live over the Internet at http://www.guidedinc.com/investors.htm or http://www.viavid.net. 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 http://www.guidedinc.com/investors.htm. A replay will also
be available until January 30, 2012 by dialing (877) 870-5176 or (858)
384-5517, and using pin number 4235585.
About LuViva® Advanced Cervical Scan
LuViva is a technologically advanced diagnostic device that scans the cervix
with light and measures how the light responds with spectroscopy. The light is
analyzed for chemical and structural indicators of precancer that may be below
the surface of the cervix or misdiagnosed as benign. This technique is called
biophotonics. Unlike Pap or HPV tests or biopsies, LuViva does not require
laboratory analysis or a tissue sample, and is designed to provide results
immediately, which eliminates costly, painful and unnecessary testing. LuViva
is designed for use with women who have undergone initial screening and are
called back for follow up – called a colposcopy examination – which in many
cases involves taking a biopsy of the cervix. The device is used in conjunction
with the LuViva® Cervical Guide single-use patient interface and calibration
About Guided Therapeutics
Guided Therapeutics, Inc. is developing a rapid and
painless testing platform for the early detection of disease based on its
patented biophotonic technology that utilizes light to detect disease at the
cellular level. The companys first planned product is the LuViva® Advanced
Cervical Scan, a non-invasive device used to detect cervical disease instantly
and at the point of care. In a multi-center clinical trial, with women at risk
for cervical disease, the technology was able to detect cervical cancer up to
two years earlier than conventional modalities, according to published reports.
Guided Therapeutics has also entered into a partnership with Konica Minolta Opto
to develop a non-invasive test for Barretts Esophagus using the technology
platform. For more information, visit: www.guidedinc.com.