2. Product Presentation

3. B ASES OF F OCAL T HERAPY

4. Focal Therapy Rationale Focal therapy represents the perfect balance between Active Surveillance and Over-treatment Focal Therapy is the future of prostate cancer therapies Focal therapy relies on accurate imaging to target the area to be treated Focal Therapy needs controlled energy to treat the designated area Focal therapy needs precise tools to evaluate the treated area

5. 1. Localization2. Treatment3. Validation The 3 pillars of Focal Therapy

6. 1. Localization2. Treatment3. Validation The 3 pillars of Focal Therapy

7. Focal Imaging MR images reading Identification and Record of Tumors Image registration Software tools 1. Localization

8. 2. Treatment3. Validation The 3 pillars of Focal Therapy

9. 2. Treatment Focal Treatment Position Accurately energy to be delivered Precise energy delivery Ability to follow precisely a contour

10. 1. Localization2. Treatment3. Validation The 3 pillars of Focal Therapy

11. 3. Validation Focal Control Immediate validation of effective treatment Compare effectively treated areas with planning Ability to complete treatment if necessary

12. 1. Localization2. Treatment3. Validation The 3 pillars of Focal Treatment ALL IN ONE DEVICE

13. Focal-One Value Proposition is EVOLUTION R Focal Treatment is the future of prostate cancer therapies… TODAY FocalOne is the first therapeutical device dedicated to Focal Therapy FocalOne brings Imaging, Therapy, and Validation into a single device FOCAL

14. P RODUCT D ESCRIPTION

15. FocalOne Principles Pre-treatment imaging MRI Import (from CD/DVD or PACS) MRI fusion with Focal-One RTUS Targeting of areas identified on the MRI Treatment Process Precise treatment area contouring Accurate Dynamic Focusing HIFU Post-treatment imaging Contrast Ultrasound Imaging Treatment Completion option

16. P RE - TREATMENT IMAGING

17. Pre-treatment planning 1- MRI Import MRI images from CD/DVD/PACS (Dicom) Edit Contour of Prostate and Target areas Load previously defined contour Start contouring on FocalOne

18. Pre-treatment planning 2- Real-time Ultrasound Volume Acquire Ultrasound Volume Edit Contour of Prostate

19. Pre-treatment planning 3- MRI / Ultrasound elastic fusion Automatic registration of 3D contours of prostate (3D translations and rotations) Elastic deformation of the MRI volume to match Ultrasound contours Transformation applied to MRI target areas to be visualized in the ultrasound referential +

20. T REATMENT P ROCESS

21. Pre-treatment planning Treatment Area Planning Precise contouring of the area to be treated Automatic dispatch of individual lesions

22. FocalOne Dynamic Focusing Probe 8 focal points from 32mm to 67mm ( △ f = 5 mm) Unitary HIFU lesion stacking Shooting process : 1s ON /foci ; no OFF Unitary HIFU lesion height = 5mm Max Reachable depth (A-P Distance): 40 mm Dynamic focusing treatment 16 isocentric rings = 16 ways Equal surfaces Electronic displacement of focal point Natural focal point @ 60 mm

23. Pre-treatment planning Treatment tracking Ability to pause at any time during the process Modify planning of slice being treated Ability to update the planning of upcoming slices Review the patient information (baseline, biopsy reports, etc…) without stopping the treatment Track the progress of the overall treatment with virtual 3D prostate

24. T REATMENT V ALIDATION

25. Contrast-Enhanced Ultrasound Treated area validation Use of standard Contrast-Enhanced Ultrasound Technology Allows to confirm de-vascularized area Allows to re-treat areas not completely treated

26. P RODUCT O FFERING

27. Configurations and Options  Dual Touch-Screen Interface  Dynamic Focusing Probe  Internal B-K UltraView  MRI images import from CD/DVD/PACS (DICOM 3.0)  Automatic elastic Fusion between MRI and Ultrasound F OCAL O NE  Contrast Imaging Ultrasound C ONTRAST O PTION

28. F OCAL O NE D ESIGN C ONCEPT

29. Patient Positioning Use of the OR table

30. Surgeon position

31. Transport Position