Microsoft word - 5_13_08 tyrx pr_final.doc


Bill Edelman
CEO, TyRx Pharma, Inc.
Office: 732-246-8676
Direct: 732-964-1101
Cell: 617-759-5451
[email protected]
TyRx Pharma, Inc. Announces the First Human Implant of the
AIGIS RX™ Anti-Bacterial Envelope in Cardiac Patient

Monmouth Junction, NJ, (May 14, 2008) -- TyRx Pharma, Inc., the leader in the
marketing of convergent drug—device products, announced today that the first
commercial implant of the AIGISRX™ Anti-Bacterial Envelope in a CRMD procedure
was conducted at St. Luke’s Episcopal Hospital of the Texas Heart Institute in Houston.
The new antibacterial envelope device is designed to stabilize pacemakers (IPG) and
implantable cardioverter defibrillators (ICD) with the additional benefit of reducing
potential risks of infections associated with implantation.
The first in-man commercial implant was performed during a pacemaker replacement
procedure on a 72-year-old male patient by Dr. Ali Massumi, Director of the Center for
Cardiac Arrhythmias and Electrophysiology at St. Luke’s and Clinical Professor of
Medicine at Houston’s Baylor College of Medicine. Dr. Massumi inserted a replacement
dual chamber pacemaker into the AIGISRX™ antibacterial envelope in less than a
minute. The AIGISRX™ IPG device combination was subsequently implanted in the
patient and the IPG replacement procedure was conducted normally thereafter.
AIGISRX™ CRMD is intended to securely hold a pacemaker or implantable cardioverter
defibrillator (ICD) in order to create a stable environment when implanted in the body. In
addition, AIGISRX™ CRMD contains the antimicrobial agents, rifampin and
minocycline, which have been shown to reduce infection by organisms representing a
majority of the infections reported in CRMD related endocarditis, including “superbugs”
or MRSA.
AIGISRX™ CRMD is constructed of knitted filaments of polypropylene coated with a
proprietary resorbable polymer that elutes the antimicrobial agents rifampin and
minocycline for a minimum of seven days to reduce the risk of infection of the implanted
CRMD following surgery. In in vitro studies, AIGISRX™ CRMD demonstrated
antimicrobial activity against Methicillin Resistant Staphylococcus aureus (MRSA),
Staphylococcus aureus, Staphylococcus epidermidis, Acinetobacter baumanii,
Enterobacter aerogenes
and Proteus mirabilis.
AIGISRX™ CRMD also demonstrated in vivo effectiveness in reducing infection
compared to control in a series of animal studies in which CRMDs were placed into
AIGISRX™ CRMD envelopes and implanted into subcutaneous pockets inoculated with
various bacterial strains, representing a majority of the infections associated with CRMD
related endocarditis. Both AIGISRX™ CRMD and the controls (CRMD without
envelope) were inoculated and observed for a minimum of seven days to validate the
presence of infection in the animals. The bacteria tested included Staphylococcus
epidermidis, Acinetobacter baumanii, Staphylococcus capitis and Escherichia coli,
separately, Staphylococcus aureus which represent a majority of the infections reported
in CRMD-related endocarditis. The in vitro and in vivo activity of the AIGISRX™
CRMD antimicrobials is variable against non-epidermidis strains of coagulase-negative
staphylococci. AIGISRX™ was cleared for market by the US FDA in January of this
According to a recent study presented during the Heart Rhythm Society Heart Rhythm
Scientific Sessions (Boston), the University of Pittsburgh Medical Center noted that
the 2003 national incident of infection for pacemakers was estimated to be 5.82% and for
ICDs 3.71%. Recent market research indicates that more than 400,000 CRMDs are
implanted each year in the U.S.
“The first in-man implant of AIGISRX™ CRMD is of course a significant milestone for
this innovative product,” said Bill Edelman, CEO of TyRx Pharma, who today introduced
the product to attendees of the Heart Rhythm Society Heart Rhythm 2008, the premier
conference on cardiac arrhythmias, in San Francisco. “There are more than 400,000
annual U.S. implants of CRMDs, and we’re confident that AIGISRX™ CRMD will
enable doctors everywhere to substantially suppress bacterial infection of CRMD

“Pacemakers are placed in an area where there aren’t a lot of blood vessels, so systemic
antibiotics may not reach the specific area. Replacing leads which run from the
pacemaker to the heart can be quite difficult because of scarring in the area. These high
risk patients are more prone to infection and obviously we want to avoid any infection to
the heart,” said Dr. Massumi.
The patient who received the new pacemaker received his first pacemaker about seven
years ago. The patient received the new pacemaker Monday morning and was discharged
from St. Luke’s Episcopal Hospital several hours later.
“The envelope provides antibiotic protection for about 10 days after the procedure. It also
helps to stabilize the device in the body. This device will also make it easier for future
device replacement. Our patient had a large amount of scar tissue around his previous
pacemaker, and we removed the scar tissue before implanting the new pacemaker,” said
Dr. Massumi.

According to Infection Control Today (8/2003), the average cost of each infection related
to invasive medical devices varies from $34,000 to $56,000; these infections incur an
annual financial burden up to $2.3 billion to the American healthcare system. The New
England Journal of Medicine (2004;350:1422-9) states about half of the two million
cases of nosocomial infection that occur each year in the United States are associated
with indwelling devices. Infections associated with surgical implants are generally more
difficult to manage because they require a longer period of antibiotic therapy and
repeated surgical procedures.
About TyRx Pharma, Inc.
TyRx Pharma, Inc., an ISO 9001:2000 and ISO 13485:2003 certified medical device
manufacturer, commercializes implantable combination drug—device products utilizing
novel biomaterials, including technology licensed exclusively from Rutgers, The State
University of New Jersey. Additionally, TyRx has exclusively licensed from Baylor
College of Medicine and The University of Texas M. D. Anderson Cancer Center product
patents and associated technologies to address the problem of postsurgical nosocomial
infection. TyRx is deploying its capabilities across a broad range of combination
implantable medical-pharmaceutical devices. The combination products sector (products
incorporating both a drug & a device component) is expected to be the highest growth
segment of the medical products industry and TyRx is positioned to be an innovative
applications leader in the space.
For more information, please visit


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Microsoft word - riskinfo-mifiduppdatering-0709271.doc

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