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New Liquid Chemical Sterilization System Submitted for 510(k)
Clearance
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Third Quarter Earnings Announcement Scheduled for January 27,
2009 MENTOR, Ohio, Jan.
20 /PRNewswire-FirstCall/ -- STERIS Corporation (NYSE: STE) today announced that it has
submitted to the U.S. Food and Drug Administration (FDA) a new
liquid chemical sterilization system for 510(k) clearance. The new
submission follows discussions with the FDA regarding issues raised in a
May 2008 warning letter relating to the Company's SYSTEM 1
Sterile Processing System. The new liquid chemical sterilization system
submitted to the FDA addresses the changes referenced by the FDA in the
warning letter and includes additional technology updates.
The Company is communicating to Customers that STERIS will continue supporting the existing
SYSTEM 1 installed base by providing accessories, sterilant, service and
parts, and replacement processor units for at least a two year period. In
the U.S., STERIS will continue
sales of SYSTEM 1 processors only as replacements for existing units.
Customers can continue using SYSTEM 1 without any change. The FDA has
reviewed and accepted these actions and is not requiring modification of
clinical practices or notification to doctors or patients. Once the new
liquid chemical sterilization system is cleared for market use by the FDA,
the Company will work with Customers to transition them to the new
product.
"Our highest priorities are patient safety, legal and regulatory
compliance, and Customer satisfaction," said Walter
Rosebrough, president and chief executive officer of STERIS
Corporation. "We are pleased that
our discussions with the FDA have resulted in the submission of a new
liquid chemical sterilization system and a path forward in resolving the
warning letter related to SYSTEM 1. We look forward to working with the
Agency to obtain clearance of our new system, and resolving any remaining
regulatory issues."
For fiscal 2009, ending March 31, 2009, the Company
anticipates that this development will not have a material impact on its
consolidated financial results. Beginning in fiscal 2010, the Company
anticipates that annualized revenues will be modestly impacted by
approximately $10 million until the new product is cleared
and commercialized.
Third Quarter Conference Call
The Company will issue fiscal 2009 third quarter earnings before the
market opens on January 27, 2009, followed by a conference
call at 10:00 a.m. Eastern time. The conference call can be
heard live over the Internet at http://www.steris-ir.com/ or via
phone by dialing 1-888-392-9976 in the United States
and Canada, and 1-517-645-6486 internationally, then
referencing the password "STERIS."
About SYSTEM 1
SYSTEM 1 is a low temperature liquid sterilizer which allows healthcare
providers to sterilize heat sensitive medical instruments, primarily
flexible endoscopes. Revenues for SYSTEM 1, including the capital
equipment, related consumables and accessories, are approximately 10% of
total Company revenues.
About STERIS
The mission of STERIS Corporation is to provide a healthier today and safer
tomorrow through knowledgeable people and innovative infection prevention,
decontamination and health science technologies, products and services.
The Company's more than 5,000 dedicated employees around the world work
together to supply a broad array of solutions by offering a combination of
equipment, consumables and services to healthcare, pharmaceutical,
industrial and government Customers. The Company is listed on the New
York Stock Exchange under the symbol STE. For more information,
visit http://www.steris.com/.
This news release, and the conference call referenced here, may contain
statements concerning certain trends, expectations, forecasts, estimates,
or other forward-looking information affecting or relating to the Company
or its industry that are intended to qualify for the protections afforded
"forward- looking statements" under the Private Securities Litigation
Reform Act of 1995 and other laws and regulations. Forward-looking
statements speak only as to the date of this report, and may be identified
by the use of forward-looking terms such as "may," "will," "expects,"
"believes," "anticipates," "plans," "estimates," "projects," "targets,"
"forecasts," "outlook," "potential," "confidence," and "seeks," or the
negative of such terms or other variations on such terms or comparable
terminology. Many important factors could cause actual results to differ
materially from those in the forward-looking statements including, without
limitation, disruption of production or supplies, changes in market
conditions, political events, pending or future claims or litigation,
competitive factors, technology advances, actions of regulatory agencies,
and changes in government regulations or the application or interpretation
thereof. Other risk factors are described in the Company's Form 10-K and
other securities filings. Many of these important factors are outside
STERIS's control. No assurances
can be provided as to any outcome from litigation, regulatory action,
administrative proceedings, government investigations, warning letters,
cost reductions, business strategies, level of share repurchases, earnings
and revenue trends, expense reduction or other future financial results.
Unless legally required, the Company does not undertake to update or
revise any forward-looking statements even if events make clear that any
projected results, express or implied, will not be realized. Other
potential risks and uncertainties that could cause actual results to
differ materially from those in the forward-looking statements include,
without limitation, (a) the potential for increased pressure on pricing
that leads to erosion of profit margins, (b) the possibility that market
demand will not develop for new technologies, products or applications,
including the new sterilization system referenced here, or the Company's
business initiatives will take longer, cost more or produce lower benefits
than anticipated, (c) the possibility that application of or compliance
with laws, court rulings, regulations, regulatory actions, including
without limitation the previously disclosed FDA warning letter,
certifications or other requirements or standards may delay or prevent new
product introductions, affect the production and marketing of existing
products, or otherwise affect Company performance, results, or value, (d)
the potential of international unrest or effects of fluctuations in
currencies, tax assessments or rates, raw material costs, benefit or
retirement plan costs, or other regulatory compliance costs, (e) the
possibility of reduced demand, or reductions in the rate of growth in
demand, for the Company's products and services, (f) the possibility that
financial impact or other outcomes may not be as anticipated, or that
transition, labor, competition, timing, execution, regulatory,
governmental, or other issues or risks associated with the matters
described in this release or the conference call referenced here,
including the impact on the currently marketed sterilizer or the ability
to obtain clearance or market acceptance of the new sterilization system,
may adversely impact Company performance, results, or value, (g) the
effect of the credit crisis on our ability, as well as the ability of our
customers and suppliers, to adequately access the credit markets when
needed, and (h) those risks described in our Annual Report on Form 10-K
for the year ended March 31, 2008, filed with the SEC on
May 30, 2008, under Item 1A, "Risk Factors," and the
Quarterly Report on Form 10-Q for the quarter ended September 30,
2008 and filed with the SEC on November 10, 2008,
under "Legal Proceedings" SOURCE STERIS Corporation
CONTACT: News Media: Stephen Norton,
+1-440-392-7482, Investors: Julie Winter,
+1-440-392-7245, both of STERIS Corporation Web site: http://www.steris.com/
(STE) |