The IVIS Suite is an integrated ensemble of hardware and software devices, individually named Precisio, pmetrics, Cipta, Clat, RoMa and Ires.

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2 ivis Suite The IVIS Suite is an integrated ensemble of hardware and software devices, individually named Precisio, pmetrics, Cipta, Clat, RoMa and Ires. The integration among the devices provides for wireless interconnection, full process automatization and close loop web based control.

3 ivis Suite All of them are designed, engineered and produced directly by IVIS Technologies, to grant the surgeon to plan and to execute cten (custom Trans epithelial no-touch) surgeries. cten is ideated to optimize patient quality of vision, to minimize treatment invasiveness and to avoid intraoperative risks.

4 ivis Suite cten grants the execution of the following customized refractive procedures procedures: Refractive diseases for far vision as myopia, hyperopia, myopic astigmatism, hyperopic astigmatism and any respective combination, all in one named as Class R procedures; Refractive diseases for near and far vision to treat any refractive disease together with presbyopia all in one named as Class M procedures

5 ivis Suite o cten grants the execution of the following customized complex therapeutic corneal diseases, all in one named as Class T procedures, as Custom therapeutic procedures

6 ivis Suite o cten grants the execution of the following customized complex therapeutic corneal diseases, named as Class TC procedures: Custom regularization and cross-linking surgery

7 ivis Suite The on-site ivis Suite 4D process

8 Precisio High Definition Surgical Tomography High definition, surgical grade, corneal elevation data: Anterior, stromal and posterior elevation maps Epithelium, stromal and total pachimetry Anterior chamber depth and iris maps Anterior posterior and total refractive power analysis: Ray tracing refractive maps Axial refractive maps Tangential refractive maps Mean power refractive maps Aconic fitting Morphological and Refractive repeatability analysis Horizontal and vertical angle K 6 degree of freedom eye tracker display Fixation score Diagnostic analysis and clinical follow-up Surgical outcomes and surgical follow-up

9 Precisio High Definition Surgical Tomography Synchronous stereo high resolution CMOS tandem cameras granting: Acquisition of over data point per each detected surface High speed fully automated acquisition of 60 images in one second 3D synchronous tracking of all six spatial degrees of freedom Certified repeatability of the acquired maps below 3um Ocular features mapping for 3D intra-operative registration Ultrathin blue laser slit for HD imaging Automated voice guided system of patient positioning and acquisition 3D motorized chin rest Touch screen monitor and intuitive user interface Realtime exams backup

10 Precisio High Definition Surgical Tomography The diagnostic analysis provides for the identification and qualification of the irregular refractive disorders. The analysis of a specific set of morphological parameters allows to identify and distinguish the family of the stable irregular refractive disorders, as the irregular astigmatism, from the family of the ectatic irregular refractive disorders, as the Keratoconus. ABSENCE OF IRREGULARITIES ECTATIC IRREGULAR CORNEAS STABLE IRREGULAR CORNEAS Suspected Keratoconus Early stage Keratoconus Intermediate Keratoconus Advanced Keratoconus Low/moderate Irregular Astigmatism Relevant Irregular Astigmatism Absence of relevant irregularities on the anterior and posterior surface have been detected. Posterior surface bulging associated with a pachimetry minimum. Absence of anterior surface bulging. Minimal anterior surface bulging associated with a posterior surface bulging and a minimum in pachimetry. Moderate anterior surface bulging associated to a posterior surface bulging and a minimum in pachimetry. Relevant anterior surface bulging associated to a posterior surface bulging and a minimum in pachimetry. Low to moderate anterior surface irregularity not associated to a posterior irregularity Relevant anterior surface irregularity not associated to a posterior irregularity

11 Precisio High Definition Surgical Tomography Diagnostic analysis outcome for a moderate mid-peripheral keratoconus.

12 Precisio High Definition Surgical Tomography The opacity analysis identifies and quantifies the reduction of transparency of the cornea.

13 Precisio High Definition Surgical Tomography The risk of glaucoma is assessed trough the measurement of the angular separation between the corneal endothelial surface and the anterior surface of the peripheral iris structure.

14 Precisio High Definition Surgical Tomography The Clinical follow-up provides a time related evaluation of the morphological and refractive stability of the corneal pathology which is identified by mean of the diagnostic analysis.

15 Precisio High Definition Surgical Tomography The surgical outcomes evaluates the morphological and refractive performance of a corneal surgery by mean of an objective differential analysis between the expected post op outcomes and the achieved post-op outcomes.

16 Precisio High Definition Surgical Tomography The surgical follow up provides a time related evaluation of the morphological and refractive stability of the surgical outcome, by mean of the differential analysis between two post operative exams acquired during a time lapse of at least three months.

17 pmetrics Ideal Pupil Definition through Dynamic Pupillometry Dynamic, binocular pupillometer Records eye-tracked pupil function in 6 lighting environments from scotopic to photopic Uniquely, pupil dimensions are statically evaluated with a patented lifestyle weighting to calculate the Ideal Pupil dimension

18 pmetrics Ideal Pupil Definition through Dynamic Pupillometry The Ideal Pupil statistically defines the diameter which encompasses 95% (2 SD) of the typical conditions a patient encounters during his waking hours. Minimize tissue removal Provide assurance of pupil coverage with statistically appropriate dimension Ideal Pupil is a critical dimension for: Refractive surgery optical zone; Selection of minimum IOL diameter for anterior and posterior chamber lenses.

19 pmetrics Ideal Pupil Definition through Dynamic Pupillometry Tested environments (diffuse and glare) range from scotopic to photopic with defined or custom luminosity settings.

20 Custom Vision Surgical Design Corneal surgery customization must improve quality of vision and minimize treatment invasiveness. To achieve this results ivis Technologies patented a customized treatment strategy requiring combination of: elevation data refractive data pupillometry The state of the patient s corneal stability dictates the strategy. Design custom refractive and therapeutic surgery. Design custom lamellar transplantation.

21 Principles The CIPTA designed custom ablation is based uponthe three following principles: Volume of the ablation The volume of the corneal tissue to be ablated is determined by the intersection between the anterior corneal surface and the ideal anterior corneal shape. Refractive zone The refractive zone is limited by the diameter equal to the sum of the projected ideal pupil onto the ideal corneal shape added of the distance included between the center of the treatment and the pupil centroid. Connecting Zone The connecting zone between the refractive zone and the remaining untouched surface of the cornea is designed to grant a constant slope in each radial direction.

22 Principle 1: Volume Real Measured Surface The Ideal refractive surface is defined by a vector sum between the total corneal photopic refraction and the intended refractive correction. Intersecting the Ideal refractive surface to anterior corneal surface defines the ablation volume. This is not applying an ablation based upon a lens where: Corneal irregularities are not accounted for (standard ablations) Corneal high order aberrations are added (wavefront ablations)

23 Principle 2: Area The intersection of the anterior surface of the cornea and the ideal refractive surface, should cover the projection of the Ideal Pupil on the anterior surface of the cornea added of the offset between the coreal apex or center of the treatment and the pupil center. This ablation will minimize tissue removal while assuring that the refractive correction covers the functional corneal surface.

24 Principle 3: Transition zone The connecting zone is designed to maintain a constant slope with linear variation of curvature. This results in a customized variable width of each one hemimeridian and is limited only by the area of valid elevation data for the most critical hemimeridian. Most critical hemi-meridian Transition zone Limit of valid elevation data The constant slope generates a variable width and is critical to mitigate risk of regression Optical Zone

25 cten : Custom Trans Epithelial No-touch Simplified, custom, one-step, all-laser, no-touch treatment Total treatment typically complete in less than 30 seconds Uses epithelium as a natural fluid masking agent to eliminate variability of epithelial thickness due to remodeling Epithelium covering irregular stroma has a smoothing tendency Surface under the epithelium is very different than the measured surface The planned postoperative surface is moved below the epithelium 85 µm 35 µm

26 ires High Resolution, Ultrafast Laser System Patented technology to grant doubling laser head speed to achieve ultra-fast 1 khz maximum frequency with an high resolution spot size of 650 µm. Patented technology to grant constant frequency laser spot delivery per area (CF/A ) to achieve a perfectly smooth and regular post op ideal surface. ifidelity eye tracker Full automatized processes cten no touch Customized ablation profiles execution for refractive and therapeutic corneal surgeries

27 ires High Resolution, Ultrafast Laser System Doubling speed patented technology A patented opto-mechanical hardware and a dedicated software grants for doubling laser head beam to achieve ultra-fast 1 khz maximum frequency with an high resolution spot size of 650 µm. Beam 1 delivery system Laser head Beam doubler Beam 2 delivery system

28 ires High Resolution, Ultrafast Laser System CF/A patented technology 6 mm layer 2 mm layer Legacy laser Variable F/A 2 mm layer ires CF/A Plume effect increases significantly as treatment area decreases due to increased pulse rate/area. With CF/ A, corneal pulse rate is controlled, remaining constant per area, regardless of ablation layer size. Laser spot returns to same position approx 9 times faster: increased & variable plume effect Laser head frequency: constant Corneal frequency/mmq: variable Laser spot returns to same position at same rate (4 Hz/mm 2 ) regardless of layer area: predictable plume effect Laser head frequency: variable Corneal frequency/mmq: constant Animations are slowed by 15X, with actual CF/A at 5 Hz/mm 2

29 ires High Resolution, Ultrafast Laser System CF/A patented technology 6 mm layer 2 mm layer Legacy laser Variable F/A 2 mm layer ires CF/A Plume effect increases significantly as treatment area decreases due to increased pulse rate/area. With CF/ A, corneal pulse rate is controlled, remaining constant per area, regardless of ablation layer size. Laser spot returns to same position approx 9 times faster: increased & variable plume effect Laser head frequency: constant Corneal frequency/mmq: variable Laser spot returns to same position at same rate (4 Hz/mm 2 ) regardless of layer area: predictable plume effect Laser head frequency: variable Corneal frequency/mmq: constant Animations are slowed by 15X, with actual CF/A at 5 Hz/mm 2

30 ires High Resolution, Ultrafast Laser System CF/A patented technology 6 mm layer 2 mm layer Legacy laser Variable F/A 2 mm layer ires CF/A Plume effect increases significantly as treatment area decreases due to increased pulse rate/area. With CF/ A, corneal pulse rate is controlled, remaining constant per area, regardless of ablation layer size. Laser spot returns to same position approx 9 times faster: increased & variable plume effect Laser head frequency: constant Corneal frequency/mmq: variable Laser spot returns to same position at same rate (4 Hz/mm 2 ) regardless of layer area: predictable plume effect Laser head frequency: variable Corneal frequency/mmq: constant Animations are slowed by 15X, with actual CF/A at 5 Hz/mm 2

31 ires High Resolution, Ultrafast Laser System CF/A patented technology Demonstration of Frequency Plume - Ablation Efficiency Low Frequency High Frequency These ablation profiles are executed with equal: number of more time to clear plume less time to clear plume layers, energy fluence, spot dimensions, and overlap pattern. more ablative energy less ablative energy The only delivered parameter to surface that varies here is the delivered delivery to frequency. surface Low Frequency (50 Hz) High Frequency (500 Hz)

32 ires High Resolution, Ultrafast Laser System The combination of a CIPTA customized trans-epithelial corneal regularization together with a cross-linking procedure allows, in one surgical step, to improve quality of vision, correcting higher order of aberrations, while stopping the progression of the ectasia for keratoconic pathologies. The CCR procedure provides for: Laser epithelial debridement Corneal regularization to compensate higher order aberration with low invasiveness Crosslinking procedure in the same surgical session

33 iverify iverify is designed to provide the capability to Close the loop of the entire surgical process of the ivis Suite to provide: o Objective analysis of the refractive outcomes o Fine tuning of the efficiency of the ires laser Pre-op exam Ablation Expected post-op - = Expected post-op Achieved post-op exam Follow-up - =

34 iverify iverify generates the follow up analysis on Precisio. The generated statistics is automatically delivered to the Users website.

35 ivis Technologies Innovative Solutions for Custom Refractive and Custom Therapeutic Surgeries Thank you for your attention

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