DOBI Medical International, Inc. DBMI) announced
today that the Russian Federal Service of Health Care and Social
Development Control has granted the Company's ComfortScan(R) system
approval for use in connection with the diagnosis of breast cancer for
the Russian Federation pursuant to certificate number 2006/415. The
approval extends for a 10-year period through April 2016.
The application for approval was based on the results of clinical
studies conducted in the Department of Radiology at the Russian State
University and the Radio diagnostic department at Gazprom Polyclinic
in Moscow. Gazprom Polyclinic is a medical clinic which principally
serves employees of Gazprom, the joint stock company which produces
approximately 90% of Russian gas.
Robert B. Machinist, chairman, said, "We are extremely pleased to
announce this achievement, as a demonstration of the Company's
strategy to seek international approvals as a parallel effort to the
completion of the US PMA clinical trials towards approval by the US
FDA of the ComfortScan system in the United States as an adjunct to
mammography."
Alex Levine, founder and CEO of SouzMedTechnika, the Company's
authorized distributor in Moscow, commented, "We have worked closely
with DOBI Medical in achieving this important milestone which will
enable us to begin offering the ComfortScan system for commercial sale
in Russia."
ComfortScan technology is based on identifying tumor angiogenesis,
the process whereby a cancerous growth surrounds itself with a dense
network of tiny blood-filled capillaries which serve to aid in its
growth and development. The ComfortScan system is designed to be used
as an adjunct to mammography, and clinical trials are evaluating its
ability to provide additional information which may aid the physician
in diagnosing breast cancer more effectively.
About DOBI Medical International, Inc.
DOBI Medical is a developmental stage, medical imaging company
working to create a new means for the improved diagnosis of malignant
breast disease through the identification of abnormal vascularization
("angiogenesis") associated with tumors. The Company's first
application of the technology is the ComfortScan(R) system, a gentle,
noninvasive, and nonionizing, optical imaging system designed to
assist physicians in the identification and management of breast
cancer as an adjunct to screening mammography. The ComfortScan system
is intended to achieve this by providing new, physiology-based imagery
of abnormal vascularization in the breast that is not readily
available today. The ComfortScan system has CE Mark and UL
designations, and DOBI Medical is a certified ISO 9001:2000, ISO
13485:2003 and CAN/CSA:ISO 13485 company. The ComfortScan system is
not yet commercially available in the U.S. as it is limited by U.S.
law to investigational use until approved by the FDA, which cannot be
guaranteed. Sales of the ComfortScan system to international
distributors are limited to sales for investigational use for
installation at clinical trial sites. For more information on DOBI
Medical International or the ComfortScan system, visit
www.dobimedical.com.
CAUTIONARY STATEMENT FOR FORWARD-LOOKING STATEMENTS
Statements contained in this press release may contain information
that includes or is based upon certain "forward-looking statements"
relating to our business. These forward-looking statements represent
management's current judgment and assumptions, and can be identified
by the fact that they do not relate strictly to historical or current
facts. Forward-looking statements are frequently accompanied by the
use of such words as "anticipates," "plans," "believes," "expects,"
"projects," "intends," and similar expressions. Such forward-looking
statements involve known and unknown risks, uncertainties, and other
factors, including without limitation, those relating to our ability
to timely and successfully complete our U.S. Food and Drug
Administration ("FDA") patient Pre-Market Approval ("PMA") clinical
trials, as well as our other clinical trials being conducted around
the world; our ability to timely and successfully complete and submit
to the FDA our PMA application of the PMA clinical trial results; the
timely and final approval by local foreign governments of our
ComfortScan system as an adjunct to mammography in various
international markets; the success and continued improvements of our
product development and research efforts, including without
limitation, our ability to timely and successfully release version 2.0
and subsequent versions of our ComfortScan system; our ability to
timely meet U.S. and foreign government laws and industry standards;
our ability to meet U.S. and foreign medical device quality regulation
standards required to maintain our CE Mark, and ISO, UL and FDA export
certifications; our ability to timely deliver our products into
international markets; the acceptance, adoption, and use of our
ComfortScan system by physicians, imaging clinics, and patients; and
our ability to obtain third-party reimbursement from U.S. and foreign
governments and private payers.
Any one of these or other risks, uncertainties, other factors, and
any inaccurate assumptions, may cause actual results to be materially
different from those described herein or elsewhere by us. We caution
readers not to place undue reliance on any such forward-looking
statements, which speak only as of the date they were made. Certain of
these risks, uncertainties, and other factors are described in greater
detail in our filings from time to time with the Securities and
Exchange Commission, which we strongly urge you to read and consider,
including the "Risk Factors" as set forth in our 2005 Annual Report on
Form 10-KSB, which may be accessed from our website at
www.dobimedical.com. Subsequent written and oral forward-looking
statements attributable to us or to persons acting on our behalf are
expressly qualified in their entirety by the cautionary statements set
forth above and elsewhere in our reports filed with the Securities and
Exchange Commission. We expressly disclaim any intent or obligation to
update any forward-looking statements.
KEYWORD: EUROPE NORTH AMERICA NEW JERSEY UNITED STATES RUSSIA
INDUSTRY KEYWORD: HEALTH CLINICAL TRIALS MEDICAL DEVICES RESEARCH & SCIENCE PROFESSIONAL SERVICES FINANCE PRODUCT/SERVICE
SOURCE: DOBI Medical International, Inc.
CONTACT INFORMATION:
DOBI Medical International, Inc.
Michael Jorgensen, 201-760-6464
Fax: 201-760-8860
www.dobimedical.com
or
Investor Relations Group
Judy Katz or Lynn Granito, 212-825-3210
Fax: 212-825-3229
www.investorrelationsgroup.com
