1/11/20151 12.10. 09 1/11/20151 12.10.2009 1/11/20151 12.10. 09 1/11/20151

04/11/23 112.10. 09 www.revitalvision.com

04/11/23 112.10.2009 www.revitalvision.com


04/11/23 1www.revitalvision.com

TECHNOLOGY & CLINICAL SUMMARY

[24.Feb.2010]

Daniel S. Durrie, MD

Overland Park, Kansas, USA





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





COMPANY OVERVIEW

This computer-based neural vision therapy (NVT) is clinically and scientifically proven to improve the vision outcomes for: Amblyopia post-cataract post-refractive (LASIK) presbyopia night vision low myopes sports vision patients Low Vision





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.





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.





RevitalVision Concept

RevitalVision optimizes the visual processing in the brain

Neurologically Retrains the Brain to See Better

VISION = OPTICS (EYE)

+ NEURAL (BRAIN)

+

Vision aids like Spectacles and contact lenses

NeuroVision





PRESENT PRODUCT OFFERINGS IN THE USA

PRODUCTS READY FOR MARKET:Amblyopia, Low Vision (Macular Degeneration), Low Myopia, Sports Vision,

Night Driving





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





SCIENTIFIC BUILDING BLOCKS

Neuronal lateral interactions

Gabor patch visual stimulus

Use of flankers

Perceptual learning

Brain plasticity





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



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

GABOR PATCH



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

First Display Second Display

Target

Flankers

USE OF FLANKERS



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.

SCIENTIFIC BASIS OF FLANKERS & COLLINEARITY



Spatial Frequency

Local Orientation

Contrast

Target-Flankers Separation

Target Displacement

Global Orientation

MANIPULATION OF GABOR STIMULUS & FLANKERS



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

BRAIN PLASTICITY



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

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




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.






CLINICAL IMPLEMENTATION

Results sent to server. Sessions adjust to

progress, improving neural performance

Results sent to server. Sessions adjust to

progress, improving neural performance

TREATMENT FLOW



After an Orientation Session the patient undergoes two computerized Evaluation Sessions

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

COMPUTERIZED EVALUATION SESSIONS



Typically patient should undergo 30 sessions during this phase (40 for amblyopia).

The patient should perform on average three (3) treatment sessions per week.

Visit interruptions longer than two (2) weeks on aggregate are discouraged.

Three (3) periodic examination are recommended along the treatment sessions to monitor and feedback patient progress.

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.



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



Motivation, consistency and compliance are key for achieving best results

Make your best efforts to concentrate and achieve the best performance during each session

Perform RevitalVision sessions at the time of day you are most alert (Not late night when sleepy)

Perform RevitalVision sessions 3 times a week

Be aware of the quality of your vision throughout the course of treatment. Experience your vision improvement during daily activities

Use your glasses less as vision improves (non amblyopic)



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 vision-training 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.



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.



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.



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.



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.



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 UCDVA improved 0.8 Snellen lines 79% improvement in contrast sensitivity function (CSF)

Control group UCDVA 0.28 line improvement 52% improvement in CSF

Patients who were worse than 20/20 after LASIK with NVT UCDVA improved 1.56 Snellen lines 90% improvement in CSF

Control group worse than 20/20 after LASIK with sham treatment 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 can improve.



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 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.



Adult Amblyopia Trial: 2000-2001

Treatment Group Control Group

Number of subjects 44 10

Average Age 35.0 ± 13.0 38.2 ± 9.4

Mean BCVA in Amblyopic EyeBefore Treatment in logMar

0.41 ± 0.14(20/51)

0.41 ± 0.12(20/51)

Mean BCVA in Amblyopic EyeAfter Treatment in logMar

0.17 ± 0.14(20/30)

0.41 ± 0.12(20/51)

Mean BCVA in Amblyopic Eye1 Year After Treatment in logMar

0.21 ± 0.14(20/33)

N/A

* FDA approved for Adult Amblyopia



Spatial FrequencySpatial Frequency

BCVA=20/30

BCVA=20/33

BCVA=20/51

12 Months Post Treatment

At End of Treatment

Before Treatment Start

Adult Amblyopia Trial: 2000-2001



Low Myopia, Singapore Eye Research Institute, 2003 - 2004

Treatment Group

Number of subjects 20

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 VABefore Treatment in logMar

0.31 ± 0.03(20/41)

Mean Unaided VAAfter Treatment in logMar

0.10 ± 0.03(20/25)

Mean Unaided VA1 Year After Treatment in logMar

0.12 ± 0.03(20/26)




UCVA=20/25

UCVA=20/26

UCVA=20/41


At End of Treatment


Low Myopia, Singapore Eye Research Institute 2003 - 2004



Low Myopia and Post Refractive SurgeryCommercial Data, 2004-2005

Low Myopia Post Refractive Surgery

Number of subjects 259 35

Average Age 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


0.43 ± 0.01(20/54)

0.32 ± 0.03(20/42)


0.17 ± 0.01(20/30)

0.10 ± 0.02(20/25)

Mean Unaided VA1 Year After Treatment in logMar (48 subjects)

0.21 ± 0.01(20/33)

N/A



Low MyopiaPost Refractive Surgery Commercial Data, 2004-2005

Low Myopia Post Refractive Surgery


UCVA=20/28

UCVA=20/54

UCVA=20/30


UCVA=20/30

UCVA=20/54

UCVA=20/33


UCVA=20/25

UCVA=20/44


UCVA=20/25

UCVA=20/42


At End of Treatment




Presbyopia, European Trial, 2005

Treatment Group

Number of subjects 41

Average Age 46.37 ± 0.52 (41-55)

Mean Near Addition +1.40D ± 0.05D


0.33 ± 0.04(20/43)


0.17 ± 0.04(20/29)




UCNVA=20/35

UCNVA=20/54


UCNVA=20/29

UCNVA=20/43

Presbyopia, European Trial, 2005


At End of Treatment




Visual Acuity Improvement

Contrast SensitivityImprovement

Retention of Improvement

1 Year PostTreatment

Main Functional Outcome

Myopia Up to -1.50D

2.6 Lines ETDRS (Distance)

Above 100% in All Frequencies

85% of the Improvement

Decrease Dependency on Spectacles

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)


Increased Quality of Functional Vision

Amblyopia 2.5 Lines ETDRS(Distance)


85% of the Improvement

Increased Quality of Vision, Improved Binocularity

Visual Improvement and Functional Outcome



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



Cataract and LASIK products can be offered to patients Bundle with surgery Offer premium package Include as part of standard of care (premium practices)

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.)

Offer to suitable candidates



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



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)



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



RevitalVision, LLCwww.revitalvision.com

NeuroVision/RevitalVision distributors:

ISRAEL- Talshir Medical Technologies Ltd.Turkey- NoroVizyon Ltd.

Greece – Vitamia Medical Ltd.

1/11/20151 12.10. 09 1/11/20151 12.10.2009 1/11/20151 12.10. 09 1/11/20151

Documents

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company overview revitalvision

contrast sensitivity

history of revitalvision

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