FDA provides LMS clearance for new core product
February 22 2005 - 7:06PM
PR Newswire (US)
FDA provides LMS clearance for new core product MONTREAL, Feb. 22
/PRNewswire-FirstCall/ -- LMS Medical Systems (AMEX:LMZ), a
healthcare technology company and developer of the CALM(TM) system
(Computer Assisted Labor Management) today announced that it has
received clearance from the United States Food & Drug
Administration to market Patterns(TM), a new and innovative
decision support software tool specifically directed at the health
of the fetus. Fetal distress during labor is recognized as one of
the greatest complexities of childbirth and therefore a significant
issue in so far as risk management is concerned. During labor and
delivery, abnormal patterns in the fetal heart rate tracing can
indicate fetal distress and thereby lead to interventions such as
more diagnostic tests or delivery by cesarean section. Patterns(TM)
uses the power of computers to provide objective, real-time
detection, classification and labeling of fetal heart rate
patterns. Better assessment of fetal distress may reduce the
incidence and severity of birth related brain damage. "Clinicians
use fetal heart rate recordings to assess the baby's tolerance to
labor. Providing quality obstetrical care requires appropriate and
timely responses to tracing abnormalities." said Dr. Emily
Hamilton, Vice- President, Medical Research and founder of LMS. "We
have designed Patterns(TM) to assist clinical teams, by providing
continuous analysis of these tracings day or night and drawing the
attention of healthcare users to important parts of the tracing."
As a core technology, Patterns(TM) can be used in a standalone
fashion or as an integrated module of the LMS Clinical Information
System. Protected by patents pending, Patterns(TM) may also be used
during the final stages of pregnancy in a medical practitioner's
office for high risk cases. Initial availability of the product is
scheduled for Q3 2005. LMS has now received regulatory clearance
for two of the three products that form its proprietary Decision
Support Suite. The first product, Curve(TM), which provides an
objective assessment of the progress of labor, is in commercial
use. Patterns(TM) is scheduled for general availability late
summer. The third and final component, ANNI(TM), a neural network
that assesses the risk of fetal damage, will commence regulatory
file preparation this spring in anticipation of an FDA submission
later in the year. About LMS: LMS is a leader in the application of
advanced mathematical modeling and neural networks for medical use.
The LMS Decision Support Suite provides physicians, nursing staff
and risk managers with clinical information systems and decision
support tools designed to improve outcomes and patient care for
mothers and their infants during labor and delivery. This press
release contains forward-looking statements that involve risks and
uncertainties, which may cause actual results to differ materially
from the statements made. For this purpose, any statements that are
contained herein that are not statements of historical fact may be
deemed to be forward-looking statements made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995. Without limiting the foregoing, the words "believes,"
"anticipates," "plans," "intends," "will," "should," "expects,"
"projects," and similar expressions are intended to identify
forward-looking statements. You are cautioned that such statements
are subject to a multitude of risks and uncertainties that could
cause actual results, future circumstances, or events to differ
materially from those projected in the forward-looking statements.
These risks include, but are not limited to, those associated with
the success of research and development programs, the adequacy,
timing, and results of clinical trials, the regulatory approval
process, competition, securing and maintaining corporate alliances,
market acceptance of the Company's products, the strength of
intellectual property, financing capability, the potential dilutive
effects of any financing, reliance on subcontractors and key
personnel, and other risks detailed from time-to-time in the
Company's public disclosure documents or other filings with the
Canadian and U.S. securities commissions or other securities
regulatory bodies. The forward-looking statements are made as of
the date hereof, and the Company disclaims any intention and has no
obligation or responsibility, except as required by law, to update
or revise any forward-looking statements, whether as a result of
new information, future events, or otherwise. DATASOURCE: LMS
MEDICAL SYSTEMS INC. CONTACT: Andrea Miller, Communications, LMS
Medical Systems Inc., (514) 488-3461 Ext. 222, Fax: (514) 488-1880,
; http://www.lmsmedical.com/
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