FDA provides LMS clearance for standalone offering of CALM Curve
April 18 2006 - 9:00AM
PR Newswire (US)
MONTREAL, April 18 /PRNewswire-FirstCall/ -- LMS Medical Systems
(AMEX:LMZ; TSX:LMZ), a healthcare technology company and developer
of the CALM(TM) system (Computer Assisted Labor Management), is
pleased to announce that it has received clearance by the United
States Food and Drug Administration to market its CALM Curve risk
management tool in a standalone fashion, independent from
previously prerequisite supporting platforms and infrastructure.
With this FDA clearance, CALM Curve will be available through a
seamless web offering, in addition to already being integrated in
the CALM clinical information system. As such, clinical teams will
be able to use the tool independently from, and irrespective of,
any obstetrical or central hospital information system that may be
in use. The internet offering of the CALM Curve will be
commercially available in the second half of 2006. CALM Curve is a
computerized method of providing consistent and objective
evaluation of labor progress. In some cases, it can therefore be
used to confirm the need for a cesarean for women demonstrating
symptoms of dystocia (slow labour). In other cases, as concluded in
cross border clinical studies involving some 11,000 first time
mothers, the use of CALM Curve, when introduced, contributed to a
safe fall in cesarean rates from 19.54% to 16.62% at 12 months (P
equals 0.00006). CALM Curve can provide meaningful assistance to
U.S. clinical teams where cesarean section rates exceeded 29% in
2005. Another clinical situation, prevalent in litigation, involves
the management of labor in women who have had a previous cesarean.
Uterine rupture is a catastrophic complication with a reported
incidence ranging from 0.2 to 1.5% in these women. Complications
associated with uterine rupture include hysterectomy, fetal death
and permanent fetal injury. In a retrospective analysis, using the
CALM Curve, abnormal labor progress was identified in 42% of cases
of uterine rupture. This diagnosis was apparent, on average, five
hours before the rupture, providing ample time for health care
professionals to intervene and avoid this complication. This is the
second CALM risk management tool to be made available over the web,
entirely independent of hospital computer infrastructure. The first
such product, CALM Shoulder Screen, is a tool designed to assess
the risk of shoulder dystocia injury, a condition representing
another severe complication occurring during labor. "We believe
CALM risk management tools to be of benefit for medical
professionals and patients alike," said Diane Cote, President and
CEO of LMS. "We will continue to focus on facilitating technology
access, implementation and delivery mechanisms so that these tools
may be readily available to clinicians in as many care settings as
possible." ABOUT LMS: LMS is a leader in the application of
advanced mathematical modeling and neural networks for medical use.
The LMS CALM(TM) Decision Support Suite provides physicians,
nursing staff, risk managers and hospital administrators with
clinical information systems and decision support tools designed to
improve outcomes and patient care for mothers and their infants
during labor and delivery. Except for historical information
contained herein, the matters discussed in this news release are
forward-looking statements. Because these forward- looking
statements involve risks and uncertainties, there are important
factors that could cause actual results to differ materially from
those expressed implied by the forward-looking statements
including, but without limitation, economic conditions in general
and in the healthcare market, the demand for and market for our
products in domestic and international markets, our current
dependence on the CALM product suite, the challenges associated
with developing new products and obtaining regulatory approvals if
necessary, research and development activities, the uncertainty of
acceptance of our products by the medical community, the lengthy
sales cycle for our products, third party reimbursement,
competition in our markets, including the potential introduction of
competitive products by others, our dependence on our distributors,
physician training, enforceability and the costs of enforcement of
our patents, potential infringements of our patents and the other
factors set forth from time to time in the Company's filings with
the United States Securities and Exchange Commission and with the
Canadian Securities Commissions. The Company has no intention of or
obligation 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/
Copyright