STEWARTVILLE, Minn., Dec. 28 /PRNewswire/ -- Rochester Medical Corporation
(Nasdaq: ROCM) In study results published in the December 1999 issue of
Antimicrobial Agents and Chemotherapy, investigators concluded that the in
vitro antibacterial activity of Rochester Medical Corporation's Release-NF(TM)
Antibacterial Foley Catheter is markedly superior in several respects to that
of C.R. Bard's Infection Control Foley Catheter.
The study, which was funded by Rochester Medical, was conducted by
Dr. James R. Johnson, Associate Professor, University of Minnesota Department
of Medicine. The Rochester Medical and C.R. Bard catheters both were tested
in vitro for inhibitory activity against historically drug susceptible strains
of Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii,
Staphylococcus aureus, Coagulase-Negative Staphylococci, and Enterococcus
faecium. Both catheters were then also tested against Multi Drug Resistant
"Superbug" strains of those bacteria types.
The study found that except for vancomycin resistant E. faecium, Rochester
Medical's Release-NF catheter was active against all the above bacterial
isolates tested, and it showed broad inhibition of the Multi Drug Resistant
strains as well as the susceptible strains of bacteria. In contrast, the
C.R. Bard I.C. catheter did not inhibit any of the above bacteria except for
certain staphylococci, and those were more actively inhibited by the Rochester
Medical Release-NF catheter and for a longer period of time. The table below
shows which bacteria were inhibited by each catheter.
Organism Rochester Medical C.R. Bard
(4 of each tested) Release-NF Bardex I. C.
Number of Isolates Number of Isolates
Inhibited Inhibited
E. coli
Susceptible 4 0
Multi Drug Resistant 4 0
K. pneumoniae
Susceptible 4 0
Multi Drug Resistant 4 0
C. freundii
Susceptible 4 0
Multi Drug Resistant 4 0
S. aureus
Susceptible 4 4
Multi Drug Resistant 4 4
Coagulase-negative
Staphylococci
Susceptible 4 1
Multi Drug Resistant 4 3
E. faecium
Susceptible 4 0
Multi Drug Resistant 0 0
Source: Activities of a Nitrofurazone-Containing Urinary Catheter and a
Silver Hydrogel Catheter against Multidrug-Resistant Bacteria
Characteristic of Catheter-Associated Urinary Tract Infection.
Authors: James R. Johnson, Parissa Delavari, and Miguel Azar.
The study points out that catheter associated urinary tract infection
(CUTI) is a major health care problem. It is the single most common type of
nosocomial infection, and because of its incidence, it is responsible for an
enormous aggregate burden of morbidity, mortality, and increased health care
costs. In recent years, antimicrobial resistance has emerged explosively
among diverse bacterial types, largely as a consequence of decades of
unrestrained antimicrobial use in agriculture and in human and veterinary
medicine. Although specific data are lacking, it is likely that the
increasing prevalence of multidrug-resistant organisms have further increased
the morbidity, mortality, and costs attributable to CUTI.
Anthony Conway, Rochester Medical's CEO said, "This is a most revealing
study. I believe Rochester Medical, with its Release-NF Anti Infection
catheter technology clearly has far outpaced the competition. The results of
the extensive testing and analysis published in this report will help
decision-makers in hospitals recognize Release-NF as the catheter likely to
provide the highest level of protection for their patients. The study
essentially found that Rochester Medical's Release-NF catheter was broadly
active in vitro against both susceptible and Multi Drug Resistant strains of
diverse bacterial species characteristic of catheter associated urinary tract
infections. In contrast, the C.R. Bard Bardex I.C. catheter was broadly
inactive; and when active, it was less potent and had more rapidly waning
activity than the Rochester Medical Release-NF catheter.
"We are working hard to spread the message of the superiority of our
product," said Conway, "as one would expect, that can be difficult in the face
of large, entrenched competition; but we are making headway, and studies such
as this one coupled with excellent clinical results in hospitals will, I
believe, lead to the recognition of the Release-NF Foley catheter as the
appropriate standard of care for many patients."
The immediately preceding statement contains forward looking statements
that involve risks and uncertainties, including the results of product
evaluations, the timing of purchases by customers, manufacturing capacities
for both current products and new products, the results of clinical tests, the
timing of clinical preference testing and product introductions, and FDA
review and response times, as well as other risk factors listed from time to
time in the Company's SEC reports, including, without limitation, the section
entitles "Risk Factors" in the Company's Annual report on Form 10-K (part II,
Item 6) for the year ended September 30, 1999.
Rochester Medical Corporation develops, manufactures and markets latex
free disposable medical catheters and devices for urological and continence
care applications. The company markets its products under its own Rochester
Medical(R) brand and under private label arrangements.
For further information, please contact Anthony J. Conway, President and
CEO, or Brian J. Wierzbinski, Chief Financial Officer of Rochester Medical
Corporation at 507-533-9600.
SOURCE Rochester Medical Corporation
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CONTACT: Anthony J. Conway, Chief Executive Officer of Rochester Medical Corporation, 507-533-9600; or General, Craig Dickson, Analysts, Leslie Loyet, or Media, Darcy Bretz, of The Financial Relations Board, 312-266-7800
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