Guided Therapeutics Partners with Three Firms to Distribute LuViva® Advanced Cervical Scan in Six European Territories
March 27 2012 - 8:05AM
Business Wire
Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today
announced that it has signed definitive agreements with leading
healthcare companies granting exclusive distribution rights for
LuViva® Advanced Cervical Scan to Fannin, plc in Ireland, Elswood
Medical Innovation in Belgium, The Netherlands, Luxembourg
(Benelux), and in the Czech Republic and Slovakia via a
sub-distributor, APTUM a.s.
The agreements are for three years and initial shipments are
currently anticipated in the second half of 2012, after receiving
CE mark approval. A formal launch is expected to begin shortly
thereafter. Guided Therapeutics has preliminary or definitive
agreements with distributors in more than 20 countries.
“Fannin is one of Ireland’s oldest and most prestigious
companies and we are pleased to partner with them to deliver
innovation to the Irish medical market,” said Mark L. Faupel,
Ph.D., CEO and president of Guided Therapeutics, Inc. “We’ve had a
long-standing relationship with Elswood’s management and believe
that their plan for introducing LuViva to the important Benelux
market, will drive ongoing sales of disposables. The Czech Republic
presents a tremendous growth opportunity for new medical technology
and APTUM is on the forefront of bringing these advancements to the
Czech and Slovak markets.”
Each year in the Benelux region, Ireland, Czech Republic and
Slovakia, an estimated 5.3 million women undergo Pap test screening
for cervical cancer, with as many as 1,008,695 receiving an
abnormal Pap result. These women are then scheduled for a follow-up
examination that could include additional lab tests or a
colposcopic exam of the cervix which, in many cases, includes a
biopsy of the cervix. Based on its clinical trial results, LuViva
could eliminate approximately 40 percent of unnecessary follow-up
procedures and could identify serious cervical disease up to two
years earlier than the standard of care.
About Fannin Ltd
Established in 1829, Fannin Ltd is Ireland's leading and longest
standing medical company. With market-leading presence within the
diagnostic, critical care, medical surgical and specialized
pharmaceutical arenas, Fannin has built significant loyalty and
partnerships within the Irish and UK medical communities.
About Elswood Group BV
The Elswood Group BV is a company committed to introducing
medical innovations from the US into Europe, especially in the
field of women’s health care. Elswood Group successfully introduced
Breast Biopsy Systems using RF Technology and Accelerated Partial
Breast Irradiation applicators through-out Europe utilizing both
direct sales operations and an intensive network of qualified
distributors.
About APTUM, a.s.
With three locations, APTUM, Inc. is a medical supply
distributor that offers specialized and consumer medical materials
from leading world and domestic producers to the entire medical
community in the Czech Republic and Slovakia. Utilizing the
expertise and professionalism of their qualified staff, APTUM
prides itself on providing a strong portfolio of innovative
products and excellent service to the Czech and Slovak markets.
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 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 with 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 disposable.
About Guided Therapeutics
Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) 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
company’s 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 Barrett’s Esophagus
using the technology platform. 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.
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: 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 uncertainty
of capital to develop products, the uncertainty of regulatory
approval of products, 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, 2010, and
subsequent quarterly reports.
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