BioniCare A proven non-drug, non-invasive

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BioniCare A proven non-drug, non-invasive
®
OuTCOMES
Many BioniCare patients return to higher level
activities such as skiing, running, tennis and the
like. Some severe osteoarthitis patients have
even returned to competitive levels that otherwise
seemed impossible. One such BioniCare patient
recovered to run in the Boston Marathon and took
first-place in his age group.
IndIcatIons For BIonIcare
The BioniCare Knee System is indicated for use as an adjunctive therapy in
reducing the level of pain and symptoms associated with osteoarthritis of the
knee and for overall improvement of the knee as assessed by the Physician’s
Global Evaluation (see clinical studies).
contraIndIcatIons
• Do not use the BioniCare Knee System for any electrode placement that
applies current to the carotid sinus (neck) region.
• Do not use the BioniCare Knee System for any electrode placement that
causes current to flow transcerebrally (through the head).
• Do not use the BioniCare Knee System when pain syndromes are
undiagnosed until etiology is established.
PrecautIons
Isolated cases of skin irritation may occur at the site of electrode placement
following long-term application.
adVerse reactIons
Skin irritation and electrode burns are potential adverse reactions.
Patients with skin irritation / reactions should be monitored.
“My knee is in better shape
than when I was in my 30’s.”
“At 68 years old, I can enjoy my life
without pain in my knee.”
WarnIngs
• The BioniCare Knee System must be used only as prescribed and applied
only to the knee.
• Patients with demand style cardiac pacemakers should consult with their
physician prior to use of this system.
• The safety of the BioniCare Knee System for use during pregnancy or birth
has not been established.
• The BioniCare Knee System is not effective for pain of central origin
(including headache).
• Use only under the continued supervision of a physician.
• Keep out of reach of children.
• Electronic monitoring equipment (such as ECG monitors and ECG alarms)
may not operate properly when the BioniCare Knee Device is in use.
IndIcatIons For oactIVetM and eagle oatM
• Mild to severe unicompartmental knee osteoarthritis.
• Medial or lateral compartment.
“I have regained my
quality of life.”
“Without the Knee Device I would have
had to have a total knee replacement.”
WarnIngs
If you experience pain, swelling, sensation changes,or unusual reactions
while using this product, contact VQ OrthoCare’s Patient Care Department
at 800.452.7993 or consult a physician.
cautIon
Federal law restricts this device to sale by or on the order of a practitioner
licensed by the law of the State in which he/she practices to use or order the
use of the device.
Real testimonial quotes from patients using the BioniCare Knee System
For more testimonials and information on
BioniCare visit www.bionicare.com
18011 Mitchell South • Irvine, CA • 92614
800.266.6969 • www.vqorthocare.com
© 2011 VisionQuest Industries, Inc.
567144
VQO151534REVE
The only treatment that can claim
to provide an overall improvement
to an osteoarthritic knee.
According to its FDA clearance, BioniCare® is “an adjunctive therapy for reducing the level of pain and symptoms
associated with osteoarthritis of the knee and for overall
improvement of the knee as assessed by the physician’s
global evaluation (see clinical studies).”
Prescribed for over 80,000 patients with
outstanding results.
BiOniCarE TEChnOlOgy
The patented BioniCare Knee System delivers an imperceptible pulsed electrical signal that was designed
specifically for the treatment of pain, symptoms and the
overall improvement of the osteoarthritic knee.
ThE MOST ThOrOughly rESEarChED nOn-Drug,
nOn-invaSivE OSTEOarThriTiS TrEaTMEnT
Comprehensive and convincing evidence for the BioniCare
Knee System’s benefits in treating knee osteoarthritis has
been well-established through five, peer-reviewed, scientific
studies involving 1,200 patients in 88 clinical settings.
BiOniCarE DElivEry SySTEMS
The BioniCare System is offered in conjunction with
the OActiveTM or Eagle OATM knee braces to provide the
immediate benefit of a proven mechanical unloading
approach, or a Night-Wrap for use while sleeping.
• Indicated specifically for knee osteoarthritis - FDA
clearance received in 2003
• Testimonials show that BioniCare works for patients
and gets them back to the activities that they enjoy
unlikE all OThErS
Researchers found that a healthy
knee produces an electrical impulse
upon weight-bearing, while in an
arthritic joint the strength of that
impulse is significantly diminished.
BioniCare delivers an electrical signal
that mimics the natural impulse and
is clinically proven to be effective.
1.8
Large Effect Size (>1.0), that of total knee replacement
1.6
1.4
Effect Size/Benefit
• Non-drug, non-invasive treatment lowers cost and avoids
side effects and risks associated with other treatments.
Physician Global Evaluation: BioniCare benefit relative to other treatment options
Decrease pain / Increase function
• Clinically proven treatment that reduces pain and
symptoms without interrupting your daily life.
Small Effect Size (0.2-0.5),
that of NSAIDs and hyaluronates
1.2
1
0.8
0.6
Good
outcomes
0.4
Best
outcomes
Better
outcomes
0.2
0
Hours of
treatment
>250
250499
500749
7501249
MONTHS
12501749
3
17502249
6
>2249
9
As hours of treatment increase, benefits increase and
use of NSAIDMONTHS
medications decreases
3
6
9
tWo electrodes:
One covers the knee and the
other one rests on the thigh
to deliver the signal
Night-Wrap
BioniCare TreaTmenT opTions To
aChieve resulTs...
Deferring TKR surgery: 4-year study of patients with severe knee osteoarthritis whose
doctor recommended a TKR
Patients NOT having Total Knee Replacement
oactIVe Knee Brace:
Low-profile, light-weight
brace provides 3 points of
leverage to reduce pressure
inside the knee joint
Eagle OATM
DOUBLE UPRIGHT
(assuming 8 hrs use per day)
FAST
100%
sIgnal generator
Four ounce, battery-powered
device generates the
proprietary electrical signal
OActiveTM
SINGLE UPRIGHT
84%
80%
* Benefits/Effect Size difference between groups in standard score,
76% between the means to standard deviation.
i.e. the ratio of the difference
69%
62%
60%
62%
33%
20%
BioniCare patients deferring TKR
Baseline
OActive or Eagle
OA brace with
BioniCare during
the day
2/3rds
40%
0%
BioniCare NightWrap at night
FASTer
24%
Control patients deferring TKR
Year 1
Year 2
7%
Year 3
less likely to have
total knee replacement
surgery when treated
with a BioniCare Knee
Device vs. controls
Year 4
Deferral of total knee replacement surgery established in
4-year study led by two Johns Hopkins University Medical
Center orthopedic surgeons
• Achieve
substantial
hours of use
while sleeping
• Dream your way
back to healthy
knees
• Achieve more
hours of use
• Minimize joint
pressure and
reduce pain
when weightbearing
FASTeST
OActive or Eagle OA
brace with BioniCare
during the day and
BioniCare NightWrap at night
• Maximize overall hours
of use to accelerate
improvement
• Minimize joint
pressure and reduce
pain when weightbearing
• Allows faster return
to pain-free function
Maximizing daily daily treatment hours gets patients back to painfree function faster.

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