Transcript Document

TECHNOLOGY & CLINICAL SUMMARY
[24.Feb.2010]
Daniel S. Durrie, MD
Overland Park, Kansas, USA
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COMPANY OVERVIEW
 RevitalVision represents a new category in vision
improvement
 Non-invasive technology that enhances eyesight
neurologically
 The company's U.S. launch is focused on improving
outcomes after intraocular lens implantation and
refractive surgery
 Average improvement of
 2 lines visual acuity
 100% in contrast sensitivity
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COMPANY OVERVIEW
 This computer-based neural vision therapy (NVT) is
clinically and scientifically proven to improve the
vision outcomes for:
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Amblyopia
post-cataract
post-refractive (LASIK)
presbyopia
night vision
low myopes
sports vision patients
Low Vision
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HISTORY OF REVITALVISION
 The NVT technology was originally developed in
Israel where the company was established in 1999.
 US FDA 510(K) approval given in August 2001 for the
treatment of adult amblyopia (age 9-55).
 The company, relocated to Singapore in 2004
under the company name NeuroVision, Inc.
 due to government interest in the treatment of pediatric
myopia in the Asian Pacific Region.
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HISTORY OF REVITALVISION
 Has treated more than 4,000 patients in Europe, the
U.S., and Asia.
 In 2009, NeuroVision was purchased by RevitalVision
LLC, and operations were relocated to the United
States, in Lawrence, Kansas.
 The technology has successfully conducted U.S.
clinical trials that replicate the international results.
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RevitalVision Concept
VISION
=
OPTICS
+
NEURAL (BRAIN)
(EYE)
+
Vision aids like
Spectacles and contact lenses
NeuroVision
 RevitalVision optimizes the visual processing in the
brain
 Neurologically Retrains the Brain to See Better
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PRESENT PRODUCT OFFERINGS
IN THE USA
PRODUCTS READY FOR MARKET:
Amblyopia, Low Vision (Macular Degeneration), Low Myopia, Sports Vision,
Night Driving
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SCIENTIFIC PREMISE
 Software-based, interactive system tailored and
continuously adaptive to individual visual abilities
 Probes specific neuronal interactions to induce
improvement of contrast sensitivity function (CSF)
due to a reduction of noise and increase in signal
strength
 Compensates for blurred inputs coming from the
retina by enhancing neural processing
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SCIENTIFIC BUILDING BLOCKS
 Neuronal lateral interactions
 Gabor patch visual stimulus
 Use of flankers
 Perceptual learning
 Brain plasticity
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NEURONAL LATERAL INTERACTIONS
 Individual neurons
respond to:
 Precise location
 Orientation
 Spatial frequency
 Neuronal Interactions:
 Result in excitation or
suppression
 Occur at multiple levels of
the visual pathway
 RevitalVision enhances these
lateral interactions
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GABOR PATCH
 Gabor Patches developed by Nobel Prize winning physicist,
Dennis Gabor
 Widely used in the field of visual neuroscience to describe the
shape of receptive fields of neurons in the primary visual
cortex
 They represent the most effective stimulation of the primary
visual cortex
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USE OF FLANKERS
First Display
Second Display
Target
Flankers
 The software measures the contrast threshold of a
Gabor target with the presence of flankers
 The patient is exposed to two short displays in
succession and the patient identifies which display
contains three Gabors
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SCIENTIFIC BASIS OF FLANKERS
& COLLINEARITY
 Lateral masking and collinear alignment of the
Gabor patches improve neuronal efficiency and
improvement of CSF by reducing the noise to signal
ratio of neural activity in the primary visual cortex.
 Animal model showed increased visual cortex
stimulation with collinearly oriented flankers (spatial
frequency patterns are oriented in a linear fasion).1
1. Polat, et al. Collinear stimuli regulate visual responses depending on cell's contrast threshold.
Nature. 1998;391: 580-4.
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MANIPULATION OF GABOR STIMULUS
& FLANKERS
Spatial Frequency
Local Orientation
Contrast
Global Orientation
Target-Flankers Separation
Target Displacement
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BRAIN PLASTICITY
 Neural plasticity relates to the ability of the nervous
system to adapt to changed conditions
 Visual acuity improvement in adults with amblyopia
has been reported
 After prolonged patching
 After the better eye’s vision has been degraded by age
related macular degeneration, cataract or trauma
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NEUROPROCESSING BASICS
 The brain pools responses across many neurons to
average out noisy activity of single cells
 improving signal-to-noise ratio, leading to improved visual
performance and acuity
 The noise of individual neurons can be brought
under experimental control by appropriate choice
of stimulus conditions
 Contrast sensitivity at low levels can be increased
dramatically through control of stimulus parameters
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NEUROPROCESSING BASICS
Hubel et al., Receptive fields of single neurons in the
cat’s striate cortex. J Physiol 1959,148:574-591
 Changes in electrical activity in a cat cortex were examined
in response to visual stimulation
 Specific neurons in the primary visual cortex respond to
specific visual stimulations
 The main parameters are location, orientation and spatial
frequency of the visual stimulus.
 In 1981 Hubel & Wiesel received Nobel Prize for this discovery,
which led to understanding of visual processing
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NEUROPROCESSING BASICS
Polat, et al. Collinear stimuli regulate visual responses
depending on cell's contrast threshold.
Nature. 1998;391: 580-4.
 Demonstrated a direct correlation between different contrast
levels and single neuron response in the primary visual cortex
 There is neural plasticity in the adult brain
 Perceptual learning can be modified
 Vision can improve by perceptual learning technique by
practicing a series of controlled and repetitive specific visual
tasks.
 The vision improvement reflects improved contrast sensitivity.
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CLINICAL IMPLEMENTATION
TREATMENT FLOW
Step 1:
ECP VA data
creates baseline
for RevitalVision
treatment
Step 2:
Patient completes
two sessions;
neural
performance
analyzed
Step 3:
20-40 customized
sessions
completed at
home via internet;
darkened room,
five feet from
screen
Step 4:
Treatment
completed. Vision
performance
maximized
Results sent to
server. Sessions
adjust to progress,
improving neural
performance
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COMPUTERIZED EVALUATION
SESSIONS
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After an Orientation Session the patient undergoes
two computerized Evaluation Sessions
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The Computerized Evaluation sessions identify the
patient’s specific visual abilities and inefficiencies
and define individual parameters that will affect
the patient’s treatment plan
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TREATMENT SESSIONS
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Typically patient should undergo 30 sessions during this phase (40
for amblyopia).
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The patient should perform on average three (3) treatment
sessions per week.
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Visit interruptions longer than two (2) weeks on aggregate are
discouraged.
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Three (3) periodic examination are recommended along the
treatment sessions to monitor and feedback patient progress.
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Amblyopic patients – should prescribed best corrected eyewear
before baseline examination, and instructed to wear
glasses/contact lenses through the entire treatment period.
In non amblyopic patients - as progress is made, the refraction of
the training glasses (previously prescribed to the patient) might
change.
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END OF TREATMENT
 Patient will terminate the treatment sequence
after 30 sessions (40 for Amblyopia)
 Following the end of treatment, the patient should
be scheduled for End of Treatment examination
 The End of Treatment Examination is a repetition of
the Baseline examination
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GUIDELINE FOR BEST RESULTS

Motivation, consistency and compliance are key
for achieving best results
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Make your best efforts to concentrate and achieve
the best performance during each session
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Perform RevitalVision sessions at the time of day you
are most alert (Not late night when sleepy)
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Perform RevitalVision sessions 3 times a week
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Be aware of the quality of your vision throughout the
course of treatment. Experience your vision
improvement during daily activities
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Use your glasses less as vision improves (non amblyopic)
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CLINICAL RESEARCH
SUMMARY
Polat U, Naim TM, Belkin M, Sagi D. PNAS
2004;101:17:6692-6697.
 Polat et al. studied 54 adult amblyopic patients who were
randomized to amblyopic NVT treatment or a placebo visiontraining program.
 Pre treatment visual acuity in both study arms was 0.42
logMAR, and this improved by 2.5 lines to 20/30 in the NVT
treatment group, with no improvement in the control group.
(statistically significant )
 This increase in acuity was corroborated by a commensurate
increase in CSF to within the normal range.
 These improvements in acuity and CSF were sustained after 12
months.
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CLINICAL RESEARCH
SUMMARY
Tan D, Fong A. Efficacy of neural vision therapy to enhance
contrast sensitivity function and visual acuity in low
myopia. J Cataract Refract Surg. 2008;Apr;34(4):570-7.
 D. Tan and A. Fong conducted a randomized controlled trial
evaluating the efficacy of NVT in low myopia.
 The results showed statistically significant difference in unaided
visual acuity between the masked and treatment groups
 Mean improvement of 2.6 logMar lines of distance uncorrected
visual acuity for low myopes,
 2.0 logMar lines near unaided visual acuity for early presbyopes.
 Results suggest evidence of efficacy and safety with NVT
treatment in improving visual acuity and contrast sensitivity
function in adult low myopes.
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CLINICAL RESEARCH
SUMMARY
Durrie D, McMinn PS. Computer-based primary visual cortex training for
treatment of low myopia and early presbyopia. Trans Am
Ophthalmol Soc. 2007;105:132-8
 D. Durrie and P. McMinn evaluated 11 patients with low
myopia (up to -1.75D) and 18 with early presbyopia (up to
+2.50D Add) in 2 clinical sites who underwent NVT.
 Control group performed only visual examinations
 Low myopia group
 Treatment group achieved a mean improvement of 2.2 logMAR
lines in UAVA.
 CSF improved at all spatial frequencies.
 Control patients did not shown any significant change in vision.
 Early presbyopia group
 Mean improvement of 2.2 logMAR lines in near UCDVA.
 Near UCSF improved at all spatial frequencies.
 The control patients did not shown any significant change in
vision.
 Mean refractive error in all groups remained unchanged after
treatment.
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CLINICAL RESEARCH
SUMMARY
Lim KL, Fam HB. NeuroVision treatment for low myopia
following LASIK regression. J Refract Surg. 2006
Apr;22(4):406-8.
 Lim et al. reported a single case of NVT for the treatment low
myopic regression five years after bilateral myopic LASIK.
 The patient improved 2.8 lines in the right eye and 1.6 lines in
the left eye following NVT.
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CLINICAL RESEARCH
SUMMARY
Tan D, Fong A 2007, Unpublished Data
 Tan et al. reported clinical data for low myopes and
presbyopes after completion of the NVT training.
 After treatment there was a mean improvement of 2.8 logMar
lines in distance UCVA for 55 low myopes
 Mean improvement of 1.6 logMar lines in near UCVA for the 41
presbyopes (age 41-55 year old)
 The improvements were shown to be retained for at least 12
months.
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CLINICAL RESEARCH
SUMMARY
Durrie, D. Slade, S. 2008 Unpublished data
Waring IV GO, Durrie DS. NeuroLASIK – Can surgeons improve
LASIK outcomes by training the visual cortex? Cataract and
Refractive Surgery Today, Aug 2008;52-53.

D. Durrie and S. Slade conducted a prospective, randomized, multicenter
placebo controlled study comparing neural vision therapy (NVT) after LASIK
(“NeuroLASIK”) to sham treatment (video game) following LASIK in 98 eyes.
Treatment group

Control group

Patients who were worse than 20/20 after LASIK with NVT

Control group worse than 20/20 after LASIK with sham treatment

 UCDVA improved 0.8 Snellen lines
 79% improvement in contrast sensitivity function (CSF)
 UCDVA 0.28 line improvement
 52% improvement in CSF
 UCDVA improved 1.56 Snellen lines
 90% improvement in CSF
 UCDVA improved 0.34 lines
 47% improvement in CSF
The results suggested that patients who had worse vision improved more and
that perhaps there is a cortical limit to how much a patient 29
can improve.
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CLINICAL RESEARCH
SUMMARY
Hunkeler J, Lindstrom D. Unpublished Data 2009
 J. Hunkeler and D. Lindstrom prospectively evaluated the
efficacy of computer based primary NVT in improving vision
after aspheric monofocal, multifocal and accommodative
Intraocular Lens (IOL) implantation of 5 different IOL styles in 60
eyes.
 After CVT, mean improvement in UCDVA and UCNVA for the
entire group was 1.3 and 1.0 lines respectively
 Mean improvement in distance and near CSF were 223% and
197% respectively.
 After CVT, mean improvement in UCDVA and UCNVA were

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Crystalens accommodative IOL (N=6) was 0.3 and 1.7
Alcon Restor (N=10) was 1.5 and 1.1
AMO ReZoom (N=24) was 1.4 and 0.7
Alcon Acrysof monofocal (N=10) was 1.3 and 0.7
AMO Technis monofocal (N=10) was 1.4 and 1.3 lines respectively.
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RESULTS OF EARLY STUDIES
Adult Amblyopia Trial: 2000-2001
Treatment Group
Control Group
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Average Age
35.0 ± 13.0
38.2 ± 9.4
Mean BCVA in Amblyopic Eye
Before Treatment in logMar
0.41 ± 0.14
(20/51)
0.41 ± 0.12
(20/51)
Mean BCVA in Amblyopic Eye
After Treatment in logMar
0.17 ± 0.14
(20/30)
0.41 ± 0.12
(20/51)
Mean BCVA in Amblyopic Eye
1 Year After Treatment in logMar
0.21 ± 0.14
(20/33)
N/A
Number of subjects
* FDA approved for Adult Amblyopia
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RESULTS OF EARLY STUDIES
Adult Amblyopia Trial: 2000-2001
12 Months Post Treatment
At End of Treatment
BCVA=20/51
Before Treatment Start
BCVA=20/30
BCVA=20/33
Spatial Frequency
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RESULTS OF EARLY STUDIES
Low Myopia, Singapore Eye Research Institute, 2003 - 2004
Treatment Group
Number of subjects
Average Age
34.0 (16 to 55)
Mean Cycloplegic Spherical Equivalence
Before Treatment
-1.08D (0 to -1.75)
Mean Cycloplegic Spherical Equivalence
After Treatment
-1.06D (0 to -1.75)
Mean Unaided VA
Before Treatment in logMar
0.31 ± 0.03
(20/41)
Mean Unaided VA
After Treatment in logMar
0.10 ± 0.03
(20/25)
Mean Unaided VA
1 Year After Treatment in logMar
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0.12 ± 0.03
(20/26)
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RESULTS OF EARLY STUDIES
Low Myopia, Singapore Eye Research Institute 2003 - 2004
12 Months Post Treatment
At End of Treatment
Before Treatment Start
UCVA=20/41
UCVA=20/25
UCVA=20/26
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Spatial Frequency
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RESULTS OF EARLY STUDIES
Low Myopia and Post Refractive Surgery
Commercial Data, 2004-2005
Low Myopia
Post Refractive
Surgery
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30 (7-55)
30 (7-55)
Mean Manifest Spherical
Equivalence Before Treatment
-1.34D ± 0.03
-1.14D ± 0.11
Mean Manifest Spherical
Equivalence After Treatment
-1.20D ± 0.04
-1.09D ± 0.12
Mean Unaided VA
Before Treatment in logMar
0.43 ± 0.01
(20/54)
0.32 ± 0.03
(20/42)
Mean Unaided VA
After Treatment in logMar
0.17 ± 0.01
(20/30)
0.10 ± 0.02
(20/25)
0.21 ± 0.01
(20/33)
N/A
Number of subjects
Average Age
Mean Unaided VA
1 Year After Treatment in logMar
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RESULTS OF EARLY STUDIES
Low Myopia
Post Refractive Surgery Commercial Data, 2004-2005
Low Myopia
Post Refractive Surgery
UCVA=20/54
UCVA=20/44
UCVA=20/42
UCVA=20/28
UCVA=20/30
UCVA=20/25
UCVA=20/30
UCVA=20/33
Spatial Frequency
Spatial Frequency
12 Months Post Treatment
At End of Treatment
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Before Treatment Start
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RESULTS OF EARLY STUDIES
Presbyopia, European Trial, 2005
Treatment Group
Number of subjects
Average Age
Mean Near Addition
46.37 ± 0.52 (41-55)
+1.40D ± 0.05D
Mean Unaided VA
Before Treatment in logMar
0.33 ± 0.04
(20/43)
Mean Unaided VA
After Treatment in logMar
0.17 ± 0.04
(20/29)
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RESULTS OF EARLY STUDIES
Presbyopia, European Trial, 2005
12 Months Post Treatment
At End of Treatment
Before Treatment Start
UCNVA=20/54
UCNVA=20/43
UCNVA=20/
UCNVA=20/35
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Spatial Frequency
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RESULTS OF EARLY STUDIES
Visual Improvement and Functional Outcome
Visual Acuity
Contrast
Improvement Sensitivity
Improvement
Retention of
Main
Improvement Functional
1 Year Post
Outcome
Treatment
Myopia
Up to -1.50D
2.6 Lines ETDRS
(Distance)
Above 100% in
All Frequencies
85% of the
Improvement
Presbyopia
Up to +1.5D
2.0 Lines ETDRS
(Near)
Average Of
100% in
All Frequencies
Delay The Need
for Reading
Glasses
Post
Refractive
Surgery
2.3 Lines ETDRS
(Distance)
Above 100% in
All Frequencies
Increased
Quality of
Functional Vision
Amblyopia
2.5 Lines ETDRS
(Distance)
Above 100% in
All Frequencies
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85% of the
Improvement
Decrease
Dependency on
Spectacles
Increased
Quality of Vision,
Improved
Binocularity
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INCORPORATING IN PRACTICE
New Treatment: “Physical Therapy for Vision”

RevitalVision enhance surgical outcomes

Little or no interruption to current practice
procedures

It’s as easy as “writing a prescription”

Therapy can be done anytime, post surgery
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INCORPORATING IN PRACTICE

Cataract and LASIK products can be offered to patients

Minimum extra intervention by doctor’s office

Amblyopia: the only clinically proven treatment to improve
vision for adult amblyopic patients

Other products: (amblyopia, presbyopia, low myopia, etc.)
 Bundle with surgery
 Offer premium package
 Include as part of standard of care (premium practices)
 Offer to suitable candidates
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INCORPORATING IN PRACTICE

Therapeutic opportunity for reduced contrast sensitivity as age
and cataract surgery contribute to decline in CSF

Empowers the patient to improve their own visual outcomes

Additional tool for patient satisfaction

Make patient’s vision better

Empower patients to improve with their home “physical therapy
for vision.”

Minimum changes necessary at practice level

All technical needs are handled by RevitalVision (distributors).

Patient progress monitored by RevitalVison

Potential source for additional revenue for physician practices
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INCORPORATING IN PRACTICE
Offer RevitalVision at Surgeon Office




Bundle with cataract surgery
Offer premium package – up charge
Include as part of standard of care (premium practices)
Referring Optometrist


Offer RevitalVision to patient at 3 or 6 month follow-up

All Post Surgical Patients

Patient undergo first guided training session at the clinic and
the rest are done at home. Any technical issues are handled
directly by RevitalVision (local distributors)
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www.revitalvision.com
www.revitalvision.com
SUMMARY

Novel approach to improvement in visual function
 “Physical therapy for vision”
 Computer based primary cortex vision training

Founded on proprietary cortical visual science therapeutic
strategies

Average improvement of 2 lines visual acuity and 100% in
contrast sensitivity

Non-invasive and safe

Multiple treatment indications offerings including amblyopia,
post IOL implant therapy, post refractive surgery, presbyopia,
Low Myopia, Low Vision, Sport Vision.

Future product offerings in development
5/2/2020
5/2/2020
12.10.2009
12.10. 09
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www.revitalvision.com
www.revitalvision.com
CONTACT INFORMATION
RevitalVision, LLC
www.revitalvision.com
NeuroVision/RevitalVision distributors:
ISRAEL- Talshir Medical Technologies Ltd.
Turkey- NoroVizyon Ltd.
Greece – Vitamia Medical Ltd.
5/2/2020
5/2/2020
12.10.2009
12.10. 09
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www.revitalvision.com
www.revitalvision.com