UroShield™ reduced Colony Forming Units
(CFU) count from >100,000 to 10,000 CFU or less in 25 of 29
patients in the treatment group
NanoVibronix, Inc, (NASDAQ: NAOV), a medical
device company utilizing the Company's proprietary and patented low
intensity surface acoustic wave (SAW) technology, today announced
the publication of an independent study, entitled “The Effect of
Surface Acoustic Waves on Bacterial Load and Preventing
Catheter-Associated Urinary Tract Infections (CAUTI) in Long Term
Indwelling Catheters,” which was published in the December 2018
issue of Medical & Surgical Urology, a leading peer-reviewed
journal in the field of urology. The study publication is available
at:
https://www.omicsonline.org/open-access/the-effect-of-surface-acoustic-waves-on-bacterial-load-and-preventing-catheter-associated-urinary-tract-infections-cauti-in-long-t-2168-9857-1000210.pdf
UroShield™ is a patented ultrasound-based product that is
designed to prevent bacterial colonization and biofilm on
indwelling urinary catheters, increase antibiotic efficacy,
ultimately reducing catheter associated urinary tract infection
(CAUTI). UroShield is also intended to decrease pain and
discomfort associated with urinary catheter use.
According to the Centers for Disease Control and
Prevention (CDC), urinary tract infections are the most common type
of health care-associated infection, accounting for more than 30
percent of reported health care-associated infections. Among UTIs
acquired in hospital settings, 70 to 80 percent are associated with
an indwelling urinary catheter. CAUTI has been associated with
increased morbidity, mortality, hospital cost and length of
stay.
This study was a double blinded randomized control trial of the
UroShield™ device. 55 patients in a skilled nursing facility chain
treated with long term indwelling catheters were evaluated. There
was a significant difference between the treated group and the
placebo group in the number of Colony Forming Units (CFU) present
upon evaluation, as well as on the number of treated UTI’s. The
effect lasted beyond the time of active treatment.
At baseline, the CFUs for all groups both in the catheter and
urine assessment were 100K or greater. There was thus no
variability between or within groups. The sham control group’s CFU
counts in both the catheter and urine assessment, remained at 100K
for each subsequent assessment (30, 60, and 90 days). Compared to
baseline, the treatment group showed significant improvement at 30
days. There was a statistically and clinically significant
reduction in the number of CFUs in the treatment group as compared
to the control group.
Mean improvement advantage in treatment vs control was 87.2K
CFU, (t (53) 18.1, p<0.001) at thirty days. At 60 days the mean
improvement advantage in treatment vs control was 87.5K CFU, (t
(53) 18.1, p<0.001). At 90 days the mean improvement advantage
in treatment vs control was 79.3K CFU, (t (53) 12.4,
p<0.001).
After cessation of treatment in the active group at 30 days,
there was a minimal increase in CFU count at both 60 and 90 days.
In the same group, there was no statistical difference in the
decrease of CFU count from 30 to 60 days after treatment, t (28)=1.
p= .326, however there was a marginally significant increase in CFU
from 60 to 90 days for the active group (28)=1.7 p= 0.09.
At baseline, every enrolled patient had been treated for
infection during the 90 days prior to enrollment. Compared to
baseline, the treatment group showed significant statistical and
clinical improvement (100%) at 30 days relative to the sham control
(73%). There were no reported infections in the treatment group
while in the control group there were seven reported
infections.
At 90 days after treatment, the treatment group showed a
significantly stronger improvement (89.7%) compared to the sham
control (46.2%). There were three reported infection in the
treatment group, while in the control group there were fourteen
reported infections requiring antimicrobial therapy. (logistic
regression B=2.3, Wald Chi-Square (df=1) =10.1, p=0.001.)
At 30 days post-treatment there were no treated infections for
both the urinary and suprapubic catheters in the treatment group.
At 90 days after treatment, the urinary catheter had fewer treated
infections (4.3%) compared to the suprapubic catheter (33.3%). This
difference was marginally significant B=2.4, Wald Chi-Square=
(df=1) =3.2, p=0.074.
The study concluded: “The UroShield™ device was shown to be
effective in significantly reducing the number of CFUs in patients
with indwelling catheters. It was also shown to be effective in
reducing the number of treated UTIs in this patient population. SAW
in the form of the UroShield™ device is an effective tool in the
prevention of CAUTI and while further evaluation is encouraged, can
be safely utilized with a high likelihood of success.”
Brian Murphy, Chief Executive Officer of NanoVibronix,
commented, "This publication is a major independent validation of
the UroShield device. The study clearly demonstrated the
ability of UroShield to dramatically reduce CFUs and there were no
reported infections in the treatment group. Importantly,
CAUTI is a leading cause of morbidity and mortality within
hospitals and skilled nursing facilities, as well as major
financial burden to the healthcare system. We believe UroShield™
has the potential to both save lives and dramatically reduce
healthcare costs. This study demonstrates a clinical
effectiveness we have not seen by any other intervention known to
us. I am encouraged and delighted with the results, which
should serve us well as we seek additional regulatory approvals for
UroShield.”
About NanoVibronix
NanoVibronix Inc. (NASDAQ: NAOV) is a medical device company
headquartered in Elmsford, New York with research and development
in Nesher, Israel, that is focused on developing medical devices
utilizing its proprietary and patented low intensity surface
acoustic wave technology. The company's technology allows for the
creation of low-frequency ultrasound waves that can be utilized for
a variety of medical applications, including the disruption of
biofilms and bacteria colonization, as well as providing pain
relief. The devices can be administered at home, without the
assistance of medical professionals. The company's primary products
include PainShield, UroShield and WoundShield. Additional
information about the company is available at:
www.nanovibronix.com.
Forward-looking Statements
This press release contains “forward-looking statements.” Such
statements may be preceded by the words “intends,” “may,” “will,”
“plans,” “expects,” “anticipates,” “projects,” “predicts,”
“estimates,” “aims,” “believes,” “hopes,” “potential” or similar
words. Forward-looking statements are not guarantees of future
performance, are based on certain assumptions and are subject to
various known and unknown risks and uncertainties, many of which
are beyond the Company’s control, and cannot be predicted or
quantified and consequently, actual results may differ materially
from those expressed or implied by such forward-looking statements.
Such risks and uncertainties include, without limitation, risks and
uncertainties associated with (i) market acceptance of our existing
and new products, (ii) negative clinical trial results or lengthy
product delays in key markets, (iii) an inability to secure
regulatory approvals for the sale of our products, (iv) intense
competition in the medical device industry from much larger,
multinational companies, (v) product liability claims, (vi) product
malfunctions, (vii) our limited manufacturing capabilities and
reliance on subcontractors for assistance, (viii) insufficient or
inadequate reimbursement by governmental and other third party
payers for our products, (ix) our efforts to successfully obtain
and maintain intellectual property protection covering our
products, which may not be successful, (x) legislative or
regulatory reform of the healthcare system in both the U.S. and
foreign jurisdictions, (xi) our reliance on single suppliers for
certain product components, (xii) the fact that we will need to
raise additional capital to meet our business requirements in the
future and that such capital raising may be costly, dilutive or
difficult to obtain and (xiii) the fact that we conduct business in
multiple foreign jurisdictions, exposing us to foreign currency
exchange rate fluctuations, logistical and communications
challenges, burdens and costs of compliance with foreign laws and
political and economic instability in each jurisdiction. More
detailed information about the Company and the risk factors that
may affect the realization of forward looking statements is set
forth in the Company’s filings with the Securities and Exchange
Commission (SEC), including the Company’s Annual Report on Form
10-K and its Quarterly Reports on Form 10-Q. Investors and security
holders are urged to read these documents free of charge on the
SEC’s web site at http://www.sec.gov. The Company assumes no
obligation to publicly update or revise its forward-looking
statements as a result of new information, future events or
otherwise.
Investor Contact:Crescendo
Communicationsnaov@crescendo-ir.com212-671-1021
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