Guided Therapeutics and FDA Review Team Agree on Path Forward for LuViva® Advanced Cervical Scan PMA Application
General Agreement reached on key objectives and endpoints for
collecting additional patient data
NORCROSS, Ga.–(BUSINESS WIRE)–Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and
painless testing platform based on its patented biophotonic technology,
announced today it believes it has reached a general agreement with the
U.S. Food and Drug Administration (FDA) on a plan for submitting an
approvable application for the LuViva® Advanced Cervical Scan.
The path forward is a result of a meeting between the company, two
leading U.S. OBGYNs and the agency’s reviewers, which include a new lead
reviewer and new OBGYN physician. Details of the plan to collect
additional patient data with the LuViva are to be finalized over the
next two to three months.
“The objectives of the meeting were certainly met and we were pleased
that the Division Director and two Deputy Directors participated. We
look forward to working with the new lead reviewer and lead OBGYN
physician to obtain U.S. approval for LuViva,” said Gene Cartwright, CEO
of Guided Therapeutics. “We expect to have the details of the plan
worked out with the agency over the next two to three months, which will
include submitting a clinical protocol for collecting the additional
patient data.
“Once the protocol is finalized, we will conduct the study, analyze the
data and present the results to the agency for review, a timeline that
entails at least a year before possible approval.”
The company was represented at the meeting by Dr. Leo B. Twiggs,
professor emeritus at the Miller School of Medicine, University of Miami
and Dr. Daron Ferris, professor at the Medical College of Georgia. Both
of whom were principal investigators of the LuViva pivotal clinical
trial and are past presidents of the American Society of Colposcopy and
Cervical Pathology.
The LuViva is designed to detect cervical pre-cancer without taking a
tissue sample and providing a result immediately, unlike any other
women’s health cancer detection technology on the market. The LuViva is
approved in Europe, Canada and Mexico and is currently available to
women in 20 countries.
World-wide, the market for cervical cancer screening and diagnostics, as
currently practiced using cytology (Pap test) for primary screening, is
estimated at $6 billion and is projected to grow to almost $9 billion by
2020. Worldwide there are about 2.6 billion women aged 15 years and
older who are at risk of developing cervical cancer.
About LuViva® Advanced Cervical Scan
LuViva is a technologically advanced diagnostic device that scans the
cervix with light and uses spectroscopy to measure how light interacts
with the cervical tissue. Spectroscopy identifies 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, HPV tests or biopsies, LuViva does not require laboratory
analysis or a tissue sample, and is designed to provide results
immediately, which may result in eliminating costly, painful and
unnecessary additional testing. LuViva is intended for use with women
who have undergone initial screening and are called back for follow up
with a colposcopy examination, which in many cases, involves taking a
biopsy of the cervix. It has also been used in clinical studies in
Turkey and Nigeria as a means to screen women for cervical cancer where
the availability of infrastructure necessary for Pap and HPV testing is
restricted. The device is used in conjunction with the LuViva®
Cervical Guide single-use patient interface and calibration disposable.
About Guided Therapeutics
Guided Therapeutics, Inc. (OTCQB: GTHP) is the maker of a rapid and
painless testing platform based on its patented biophotonic technology
that utilizes light for the early detection of disease at the cellular
level. The Company’s first 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. For more information, visit: www.guidedinc.com.
The Guided Therapeutics LuViva® Advanced
Cervical Scan is an investigational device and is limited by federal law
to investigational use in the U.S. LuViva, the wave logo and “Early
detection, better outcomes” are registered trademarks owned by Guided
Therapeutics, Inc.
Forward-Looking Statements Disclaimer: A number of the matters and
subject areas discussed in this news release that are not historical or
current facts deal with potential future circumstances and developments.
The discussion of such matters and subject areas is qualified by the
inherent risks and uncertainties surrounding future expectations
generally and also may materially differ from Guided Therapeutics’
actual future experience involving any of or more of such matters and
subject areas. Such risks and uncertainties include those related to the
early stage of products in development, the uncertainty of market
acceptance of products, the uncertainty of development or effectiveness
of distribution channels, the intense competition in the medical device
industry, the sufficiency of capital raised in our prior financings and
our ability to realize their expected benefits, the uncertainty of
future capital to develop products or continue as a going concern, the
uncertainty of regulatory approval of products, and the dependence on
licensed intellectual property, as well as those that are more fully
described from time to time under the heading “Risk Factors” in Guided
Therapeutics’ reports filed with the SEC, including Guided Therapeutics’
Annual Report on Form 10-K for the fiscal year ended December 31, 2014
and subsequent filings.
Contacts
IRTH Communications
Robert Haag, 866-976-4784
Managing Partner
gthp@irthcommunications.com
or
Guided
Therapeutics
Bill Wells, 770-242-8723
