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Presentation on theme: "1/11/20151 12.10. 1/11/20151 1/11/20151 12.10. 1/11/20151"— Presentation transcript:

1 1/11/ 1/11/ 1/11/ 1/11/ TECHNOLOGY & CLINICAL SUMMARY [24.Feb.2010] Daniel S. Durrie, MD Overland Park, Kansas, USA

2 1/11/ 1/11/ 1/11/ 1/11/ 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

3 1/11/ 1/11/ 1/11/ 1/11/ 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

4 1/11/ 1/11/ 1/11/ 1/11/ HISTORY OF REVITALVISION  The NVT technology was originally developed in Israel where the company was established in  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.

5 1/11/ 1/11/ 1/11/ 1/11/ 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.

6 1/11/ 1/11/ 1/11/ 1/11/ RevitalVision Concept  RevitalVision optimizes the visual processing in the brain  Neurologically Retrains the Brain to See Better

7 1/11/ 1/11/ 1/11/ 1/11/ PRESENT PRODUCT OFFERINGS IN THE USA PRODUCTS READY FOR MARKET: Amblyopia, Low Vision (Macular Degeneration), Low Myopia, Sports Vision, Night Driving

8 1/11/ 1/11/ 1/11/ 1/11/ 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

9 1/11/ 1/11/ 1/11/ 1/11/ SCIENTIFIC BUILDING BLOCKS  Neuronal lateral interactions  Gabor patch visual stimulus  Use of flankers  Perceptual learning  Brain plasticity

10 1/11/ 1/11/ 1/11/ 1/11/ 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

11 1/11/ 1/11/  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

12 1/11/ 1/11/  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 DisplaySecond Display Target Flankers USE OF FLANKERS

13 1/11/ 1/11/  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) Polat, et al. Collinear stimuli regulate visual responses depending on cell's contrast threshold. Nature. 1998;391: SCIENTIFIC BASIS OF FLANKERS & COLLINEARITY

14 1/11/ 1/11/ Spatial Frequency Local Orientation Contrast Target-Flankers Separation Target Displacement Global Orientation MANIPULATION OF GABOR STIMULUS & FLANKERS

15 1/11/ 1/11/  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

16 1/11/ 1/11/  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

17 1/11/ 1/11/ Hubel et al., Receptive fields of single neurons in the cat’s striate cortex. J Physiol 1959,148:  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 NEUROPROCESSING BASICS

18 1/11/ 1/11/ Polat, et al. Collinear stimuli regulate visual responses depending on cell's contrast threshold. Nature. 1998;391:  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. NEUROPROCESSING BASICS

19 1/11/ 1/11/ 1/11/ 1/11/ CLINICAL IMPLEMENTATION Step 1: ECP VA data creates baseline for RevitalVision treatment Step 2: Patient completes two sessions; neural performance analyzed Step 3: 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 TREATMENT FLOW

20 1/11/ 1/11/  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

21 1/11/ 1/11/  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. TREATMENT SESSIONS

22 1/11/ 1/11/  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 END OF TREATMENT

23 1/11/ 1/11/  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) GUIDELINE FOR BEST RESULTS

24 1/11/ 1/11/ Polat U, Naim TM, Belkin M, Sagi D. PNAS 2004;101:17:  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. CLINICAL RESEARCH SUMMARY

25 1/11/ 1/11/ 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):  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. CLINICAL RESEARCH SUMMARY

26 1/11/ 1/11/ 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. CLINICAL RESEARCH SUMMARY

27 1/11/ 1/11/ Lim KL, Fam HB. NeuroVision treatment for low myopia following LASIK regression. J Refract Surg Apr;22(4):  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. CLINICAL RESEARCH SUMMARY

28 1/11/ 1/11/ 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 year old)  The improvements were shown to be retained for at least 12 months. CLINICAL RESEARCH SUMMARY

29 1/11/ 1/11/ Durrie, D. Slade, S 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;  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. CLINICAL RESEARCH SUMMARY

30 1/11/ 1/11/ 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. CLINICAL RESEARCH SUMMARY

31 1/11/ 1/11/ Adult Amblyopia Trial: Control GroupTreatment Group 1044Number of subjects 38.2 ± ± 13.0Average Age 0.41 ± 0.12 (20/51) 0.41 ± 0.14 (20/51) Mean BCVA in Amblyopic Eye Before Treatment in logMar 0.41 ± 0.12 (20/51) 0.17 ± 0.14 (20/30) Mean BCVA in Amblyopic Eye After Treatment in logMar N/A0.21 ± 0.14 (20/33) Mean BCVA in Amblyopic Eye 1 Year After Treatment in logMar * FDA approved for Adult Amblyopia RESULTS OF EARLY STUDIES

32 1/11/ 1/11/ BCVA=20/30 BCVA=20/33 BCVA=20/51 12 Months Post Treatment At End of Treatment Before Treatment Start Adult Amblyopia Trial: RESULTS OF EARLY STUDIES

33 1/11/ 1/11/ Low Myopia, Singapore Eye Research Institute, Treatment Group 20Number of subjects 34.0 (16 to 55)Average Age -1.08D (0 to -1.75)Mean Cycloplegic Spherical Equivalence Before Treatment -1.06D (0 to -1.75)Mean Cycloplegic Spherical Equivalence After Treatment 0.31 ± 0.03 (20/41) Mean Unaided VA Before Treatment in logMar 0.10 ± 0.03 (20/25) Mean Unaided VA After Treatment in logMar 0.12 ± 0.03 (20/26) Mean Unaided VA 1 Year After Treatment in logMar RESULTS OF EARLY STUDIES

34 1/11/ 1/11/ UCVA=20/25 UCVA=20/26 UCVA=20/41 12 Months Post Treatment At End of Treatment Before Treatment Start Low Myopia, Singapore Eye Research Institute RESULTS OF EARLY STUDIES

35 1/11/ 1/11/ Low Myopia and Post Refractive Surgery Commercial Data, RESULTS OF EARLY STUDIES Post Refractive Surgery Low Myopia 35259Number of subjects 30 (7-55) Average Age -1.14D ± D ± 0.03Mean Manifest Spherical Equivalence Before Treatment -1.09D ± D ± 0.04Mean Manifest Spherical Equivalence After Treatment 0.32 ± 0.03 (20/42) 0.43 ± 0.01 (20/54) Mean Unaided VA Before Treatment in logMar 0.10 ± 0.02 (20/25) 0.17 ± 0.01 (20/30) Mean Unaided VA After Treatment in logMar N/A0.21 ± 0.01 (20/33) Mean Unaided VA 1 Year After Treatment in logMar (48 subjects)

36 1/11/ 1/11/ Low Myopia Post Refractive Surgery Commercial Data, RESULTS OF EARLY STUDIES Low MyopiaPost Refractive Surgery Spatial Frequency UCVA=20/28 UCVA=20/54 UCVA=20/30 Spatial Frequency UCVA=20/30 UCVA=20/54 UCVA=20/33 Spatial Frequency UCVA=20/25 UCVA=20/44 Spatial Frequency UCVA=20/25 UCVA=20/42 12 Months Post Treatment At End of Treatment Before Treatment Start

37 1/11/ 1/11/ Presbyopia, European Trial, 2005 Treatment Group 41Number of subjects ± 0.52 (41-55)Average Age +1.40D ± 0.05DMean Near Addition 0.33 ± 0.04 (20/43) Mean Unaided VA Before Treatment in logMar 0.17 ± 0.04 (20/29) Mean Unaided VA After Treatment in logMar RESULTS OF EARLY STUDIES

38 1/11/ 1/11/ Spatial Frequency UCNVA=20/35 UCNVA=20/54 Spatial Frequency UCNVA=20/ 29 UCNVA=20/43 Presbyopia, European Trial, Months Post Treatment At End of Treatment Before Treatment Start RESULTS OF EARLY STUDIES

39 1/11/ 1/11/ Visual Acuity Improvement Contrast Sensitivity Improvement Retention of Improvement 1 Year Post Treatment 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) Above 100% in All Frequencies Increased Quality of Functional Vision Amblyopia2.5 Lines ETDRS (Distance) Above 100% in All Frequencies 85% of the Improvement Increased Quality of Vision, Improved Binocularity Visual Improvement and Functional Outcome RESULTS OF EARLY STUDIES

40 1/11/ 1/11/ New Treatment: “Physical Therapy for Vision” INCORPORATING IN PRACTICE  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

41 1/11/ 1/11/  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 INCORPORATING IN PRACTICE

42 1/11/ 1/11/  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 INCORPORATING IN PRACTICE

43 1/11/ 1/11/  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) INCORPORATING IN PRACTICE

44 1/11/ 1/11/  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 SUMMARY

45 1/11/ 1/11/ RevitalVision, LLC NeuroVision/RevitalVision distributors: ISRAEL- Talshir Medical Technologies Ltd. Turkey- NoroVizyon Ltd. Greece – Vitamia Medical Ltd. CONTACT INFORMATION

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