Virtual MRI Guided Prostate Biopsy MRI/Ultrasound Fusion Technology 3D Semi-Robotic TargetingAdvanced 3D Imaging 3D DICOM Visualization PACS Compliant Prostate & ROI Contouring Perfusion-Diffusion Analysis Data Transfer via USB, DVD, Network or Cloud Image Histogram Analysis Easy & Efficient Workflow a Integration of pathology results into MRI for review and treatment planning, e.g. Focal Therapy ProFuse”ProFuse is a powerful mpMRI DICOM viewer that enables radiologists, urologists or radiation oncologists to identify and confirm potential prostate MR lesions for biopsy. It writes and reads from PACS. It is easily configured to user's choice. It allows advanced calculation to confirm lesion grading. Setup is quick and easy with remote license activation. The end-user receives 3-user licenses as part of the bundle platfom. This allows multiple locations to read mpMRI and mark regions of interest for biopsy procedures. Training on the software is easy and provided on-site. Pérfusion/Diffusion Analysis Prostate and ROI Contouring 4 HIRARSRepertng mpMRI Histogram Analysis ProFuse”a) oon Multi-Modality Image Fusion Supports PET/CT/MRI/US Fusion Automatic Rigid & Elastic Fusion With or Without Endorectal Coil All MR Scanners & Protocols PIRADS Reporting & Scoring Accounts for Bladder/Rectal Filling MRI Ultrasound Integrate information from mpMRI into TRUS guided biopsy ProFuse Bxinm Precision Targetin Eliminates prostate deformation for high accuracy of targeted biopsy Targeted MR/Ultrasound Biopsy « Patient Motion Compensation Custom Template Biopsy Plans Compatible with all U/S systems Easy Calibration Targeted mpUltrasound Bx Electromechanical Probe Stabilization 3D Needle Visualization & Pathology Recording 3D Semi Robotic Navigation for Prospective Targeting Detailed Reporting including Previous Biopsy Cores ArtemisArtemis lets your physician examine, map, plan and record your biopsy. Its 3D detail lets you see the precise location of suspicious tissue and/or cancer lesions. This results in advanced clinical information to aid in your diagnosis, treatment and continuing patient care. Artemisleading innovation g in medical imaging tea) Benefits Clinical Avoid freehand biopsy errors Early detection of malignant tumors’ Easy guidance to target anterior lesions Active surveillance & focal therapy Reduce repeat biopsy sessions’ Operational Quick set-up & intuitive workflow No sensor-based needle supplies No specialized room PACS, cloud & network connectivity Compatible with all MRI and U/S systems Seamless radiology-urology integration Financial Reduce unnecessary biopsy costs Reduce unnecessary supply costs Cost benefits of early detection of PCa Increased patient satisfaction & retention * Filson, Cancer, 2016 / EAU Sonn 2013 Prior Negative Blopsy Patients / Joumal OF Urology Sonn 2013 Top 5 Cited Article / Asian Journal of Andrology (2015) 17, 870-873 Bockhotionseca Clinical PCa Detection Rate Conventional U/S Blind Poke e& Hope Procedure Detection Rate: 27-40% False Negative Rate ~47% 38% Repeat Biopsy within 5 Years Often Anterior Lesions Missed (Patel AR et al. Curr Opin Urol 2009; 19:232) mpMRI Combine Anatomical & Functional Imaging Comparison of 3 Protocols in 83 Patients Protocol Sensitivity! Specificity T2W + DWI 84% 85% 84% 0.905 (Tanimoto A, JMRJ 2007) Multiparametric MRI has excellent sensitivity for detecting aggressive PCa Gleason score 7 or higherleading innovation fi in medical imaging tea) Commitment to Evidence-Based Medicine 100% | 80% ~ 60% 5 40% ~ Gleason >7 cap 20% —| 0% + No Target 2 3 4 5 # Patient 19 14 64 61 16 # Any CaP 6 6 29 34 15 #Gleason > 7 CaP 3 1 9 14 7 94% of men with image grade 5 on MRI had PCa J Urol. 2013 Jan; 189(1): 86-91. Accurate targeting of lesions identified on mpMRI using ultrasound fusion biopsy in clinicleading innovation 4 fe] in medical imaging ibeteia) Workflow mpMRI @...: Connectivity OD ccinr and Target planning @.... Transfer Ultrasound @..... Fusion @..... Planning Osc Guidance & Recording OD ererine & Documentation PSE oP] wiXd 9SnN4Old rfSSSsSSS:|E:::|::|:|:|:::|:|:|:| || | |S Artemis specifications inmedislocing SiS Intended Use Artemis is intended to be used by physicians in a clinic or hospital for 2D and 30 visualization of ultrasound images of the prostate gland. The software provides additional features such as patient data management, multi-planar reconstruction, segmentation, image measurement, and 3D image registration. Conformance Standards . IEC 60601-1: 2005 Ed.3 Compliance . AAMI/ANSI ES60601-1 (2005/02) Compliance . EN 60601-1 (7/2007) Annex ZA and Zz Compliance . CSA-C22.2 No.60601-1:20 : IEC 60601-1: 1988 +A1:1991 +A2:1995 including UL60601-1:2003, CSA C22.2, No. 601.1- M90+S1:1994 +A2:1998, EN 60601-1:1990 +A1:1993 +A2:1995+A13:1996 and CB bulletin 112A with country differences (AU, BR, IN, IL, JP, KR, RU, TR) . DICOM—Image data imported to and exported from the device is DICOM compliant. . Artemis implements the Offline-Media Application Entity. This supports the STD-GEN-CD and STD-GEN-DVD-RAM application profile. System Information NOTE: Artemis specifications are subject to change at any time without notification or obligation to device owners. System Includes: + Flat-panel 24” display + Detachable footswitch + Microsoft Windows® 7 Professional, 64-bit * Detachable cradle insert ‘+ TRUS probe mechanical tracker + Mouse Note: Artemis should not be operated in any facility above 2,000 meters (~6,000 feet). General Storage + Class 2 equipment © 2-Serial ATA 1 TB hard disk + Mode of operation: Continuous © CD/DVD R/W Lightscribe drive ‘+The unit has no patient applied parts © CPU-Intelii7 + 1P20 rating system Memory- 8 GB DDR3 DIMM. Video Card Fans. + nVidia GeForce GTX750 + Input: 24V DC + _Epiphan Card + _ULlisted Cart Dimensions Environment © Width:27" + Operating temperature range: 50-104 °F + Cart Length-Basic: 35” + Operating humidity: 0% - 85% (non- + Cart Length, Arm Fully Extended: 64" condensing) + Height: 57" + Operable after storage under the following + Pole diameter: 4” 0D environmental conditions: + Weight: “450 Ibs. + Ambient temperature range of -13 °F to 131 °F with Power Supply + Relative humidity range of 0% ~ 85% (non- ‘+ Artemis has one of these four input power, condensing) ratings, as indicated on the back of the device. | * Atmospheric pressure range of S00 hPa to + Voltage Hertz @Amax. 1050 hPa + 100 50/60 8.33 + Image Acquisition + 120 s0/60 8.33 + DVHIN + 220 s0/60 4.17 + Dv-iouT + 240 S0/60 4.17 + (@)usB * Ethernet (10/100 Base T) + pvp Drive 13366 Grass Valley Ave., Grass Valley, CA 95945, US.A.leading innovation 6 in medical imaging |Meareveall eigen brings innovation to prostate biopsy & focal therapy FDA, CE, TGA, CMDCAS Certified World-class customer support and service For more information please contact US. Headquarters: www.elgen.com Europe Office: 13366 Grass Valley Ave. Denshaw House, Grass Valley, CA 95945 120/121 Lower Baggot St. US.A. Dublin, 2 DO2 FD4 Ph: + 1530 274 1240 x 221 Fax: + 1 530 274 3656 info@eigen.com (097-00001-01 Rev B