TRIO. SPECT/CT, SPECT/CT/PET and standalone SPECT 3-head SPECT-based imager family for clinical imaging & clinical/preclinical research use

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1 TRIO SPECT/CT, SPECT/CT/PET and standalone SPECT 3-head SPECT-based imager family for clinical imaging & clinical/preclinical research use The first and only clinical Triple-Detector SPECT/CT system with Multi-PinHole collimation

Introduction of AnyScan TRIO triple-detector SPECT-based imager family Mediso s frontier development of SPECT and PET systems is based on more than 50 years of medical imaging expertise and nearly a

2 Introduction of AnyScan TRIO triple-detector SPECT-based imager family Mediso s frontier development of SPECT and PET systems is based on more than 50 years of medical imaging expertise and nearly a century of company tradition in precision engineering industries. Mediso is the only vendor in the world to design, develop and manufacture both pre-clinical research and clinical hybrid nuclear imaging systems. AnyScan TRIO SPECT/CT stems from this unique synergy as a new, breakthrough hybrid molecular imaging system. Triple-detector SPECT imaging systems have been the nuclear medicine reference for high resolution detection of various brain and cardiac abnormalities in the past three decades. The unique integration of Mediso s novel SPECT system design with Multi-PinHole collimators into a triple detector SPECT/CT hybrid imaging system now means a leap in quantitative and PET-like clinical molecular imaging. The ground-breaking hybrid technology ensures exact quantification, high resolution and very high sensitivity combined in one SPEC/CT imaging system. Mediso presents a cutting-edge Xtreme Edition of this triple-detector AnyScan TRIO SPECT/CT System. The performance is ensured by its unique, full value chain engineering design: - Xtreme Edition Detectors with 123 or 94 photomultipliers/detector - Novel, patented M6 Multi-PinHole Collimators with Organ-Specific Apertures - Three-dimensional Quantitative Reconstruction with Tera-Tomo 3D SPECT - Q Algorithms. The system is available in SPECT/CT and a tri-modality SPECT/CT/PET configuration. 2

In the Clinical Practice Edition of this Triple-Detector SPECT/CT system Mediso offers increased resolution and a significant decrease in imaging time.

3 In the Clinical Practice Edition of this Triple-Detector SPECT/CT system Mediso offers increased resolution and a significant decrease in imaging time. These qualities result in higher patient comfort, seamless nuclear medicine and clinical decision workflow and a much higher daily NM department throughput. The Clinical Practice Edition contains precise and sensitive 60-photomultiplier UHP Edition Anger detectors and parallel collimation as well as Tera-Tomo 3D SW. An optional setup of Multi-PinHole Collimators and Tera- Tomo 3D SPECT Q quantification software is available to complete an advanced clinical practice. SPECT, SPECT/CT and triple-modality SPECT/CT/PET Clinical Practice variants are on offer. 3

The Xtreme Edition triple detector AnyScan TRIO SPECT/CT System Ultra High Performance in all details AnyScan TRIO is a result of more than a decade in Mediso s Multi-PinHole SPECT collimation and

The implemented MPH technologies are widely used and approved in Mediso pre-clinical systems.

4 The Xtreme Edition triple detector AnyScan TRIO SPECT/CT System Ultra High Performance in all details AnyScan TRIO is a result of more than a decade in Mediso s Multi-PinHole SPECT collimation and detector developments. Multi-detector and Multi-PinHole collimation technologies are the gold standard in quantitative pre-clinical SPECT/CT systems. (NanoSPECT/CT, nanoscan SPECT/CT). The implemented MPH technologies are widely used and approved in Mediso pre-clinical systems. Mediso s knowledge base and expertise in Nuclear Medicine guarantees the best performances of the new AnyScan TRIO clinical and research SPECT/CT system too. Imaging Modes: Multi-PinHole Collimator Based Research Package For Alzheimer For Parkinson For Cardiology While designed with primary Cutting Edge Research applications in mind, the system is exceptional in daily clinical practice with standardized protocols too. New acquisition modes are implemented for Triple Detector Mode with 3D Whole-Body Imaging and MPH Organ Imaging. PET-like Imaging: PET has been a long-standing Nuclear Medicine imaging reference modality. Now AnyScan TRIO SPECT offers the very same imaging performance. AnyScan TRIO s system resolution, SPECT quantification and acquisition speed all match the reference. As a result overall visual and quantified image quality is similar to PET. In addition AnyScan TRIO handles dual/triple/quadruple isotope examinations with modern tracers and quantitative evaluation of the studies. TRIO also provides high quality quantitative images in high-energy isotope applications with e.g. Iodine 131. SPECT s inherent advantage of easy multi-isotope imaging means patient and clinical study benefit from day one of AnyScan TRIO use. Therapeutic isotope dosimetry can be easily combined to a disease monitoring SPECT acquisition with two or more different radionuclides. Multi-isotope imaging capacities include Ga-67 combined to I-131 or Tc-99m plus Ra-223. Triple Xtreme edition detector 1 ADC/PMT - excellent resolution MPH (Multi-PinHole) Collimator Diagnostic 16 slice CT subsystem Parallel-hole Collimator LYSO crystal Time-of-Flight PET subsystem Integrated Touch Screen monitor Gantry status, controls, Pscope and ECG display 4 Multi-modality Table Low height - high patient comfort Built-in ECG and source holder 5 leads ECG, Integrated Source holder for QC Auto Body contour Minimum object/detector distancestandardized image quality BC as Crash Prevent - improved safety

5 The comparison below shows the breakthrough AnyScan TRIO brings for SPECT imaging vs. conventional dual detector (NaI or CZT) parallel-hole collimated SPECT/CT systems. Best SPECT Volumetric System Resolution 5 X 5X higher volumetric resolution in detector performance and MPH technology compared to conventional systems. Best System Sensitivity 3X System sensitivity produced by Triple detectors and the MPH technology 3 X Best Contrast-to-Noise Ratio 2 X 2X Contrast to Noise Ratio (CNR) reached with the new Monte Carlo-based Tera- Tomo Q/MPH reconstruction Shortest Total Imaging Time 1/3 Near one third of imaging time of a conventional SPECT/CT scan with AnyScan TRIO 1/3 Lowest injected dose Near one third of administered patient dose thanks to the Triple-Detector Technologies Best Absolute Quantification Less than 5% error of absolute quantification provided by highly efficient detection, advanced modeling of physics and Tera-Tomo 3D SPECT - Q/MPH reconstruction package. 5% 5

Ground-Breaking New XTREME EDITION SPECT Detectors Three best-in-class ultra-high resolution and performance detectors Non-Anger detection logics Extra-large UFOV: 540 x 415 mm Photomultipliers:

5 mm Full Energy range Clinical Imaging from 20 kev to 600 KeV Linear maximal count rate: >600 000 cps Threefold SPECT Application Features in one Unified Imaging Platform 1.

6 Ground-Breaking New XTREME EDITION SPECT Detectors Three best-in-class ultra-high resolution and performance detectors Non-Anger detection logics Extra-large UFOV: 540 x 415 mm Photomultipliers: 94/123 pcs/detector Typical intrinsic FWHM resolution: 2.5 mm Full Energy range Clinical Imaging from 20 kev to 600 KeV Linear maximal count rate: > cps Threefold SPECT Application Features in one Unified Imaging Platform 1. Clinical Imaging with Dual/Triple-Detectors: For conventional Nuclear Medicine the Dual-Detector Mode for All Procedure allows users to cross validate their original clinical protocols. It ensures protocol transfers to the triple-head system. All examinations can thus further be conducted in PET-like visual quality* 33% of patient administered dose or in 33% of the acquisition time. The Clinical Application package includes the 60 pcs PMT UHP Anger detectors, Parallel collimators, and optional Tera-Tomo 3D SPECT - Q reconstruction package for absolute quantification. 2. Cutting Edge Clinical Research Application: To meet the most demanding research clinicians needs, the Xtreme Edition triple-detector system with Multi-PinHole technology offers two major leaps in SPECT: - Three-dimensional whole-body SPECT - Stationary Gantry - List Mode Dynamic imaging. The new Tera-Tomo 3D SPECT - Q/MPH quantitative reconstruction package includes on-the-fly quantification for dynamic studies such as kidney function SPECT. The Clinical Research Application package includes the 94/123 pcs PMT Non-Anger Xtreme Edition detectors, application specific Multi-PinHole, Parallel-hole collimators and a Tera-Tomo 3D SPECT - Q/MPH reconstruction package for absolute quantification. * PET-like visual quality is a product of Xtreme Edition detectors, Tera-Tomo 3D SPECT Q reconstruction and special collimators. 3 mm 6 Multi PinHole Neurology study setting Better than 3 mm resolution with UHR-MPH Collimator for Neurology* *Simulated image

7 3. Cutting Edge Pre-clinical Research Application: A uniquely flexible, versatile system for Pre-clinical Research: This is also AnyScan TRIO. A variety of multi-isotope simultaneous acquisitions. Pharmacokinetic modelling in SPECT just like for PET. The methods that guaranteed the success of microspect are applicable now to large-animal models of cardiac, regenerative and musculoskeletal medical research. The Preclinical Research Application package includes the 123 pcs PMT non Anger Extreme Edition detectors, application specific Multi-PinHole, Parallel hole collimators and Tera-Tomo Q/MPH reconstruction package for absolute quantification. Optimized continuous Workflow and ultra-fast Acquisition Time Clinical workflow is rendered seamless by novel AnyScan TRIO optimization through reduction in clinical decision points and scan time. One common problem during Whole Body studies is that after the planar scan a clinical decision has to be made by the physician on the next SPECT acquisition. The new Whole-Body SPECT protocol resolves this problem. There is no need for another decision during the whole body oncology scan. Thus, patient comfort, compliance and physician load are all optimized in the same time. Ultra-fast imaging offers more patient compliance due to shorter confinement. By decreasing imaging time to half, the amount of motion artifacts also decreases to a quarter. Ultra-fast imaging thus inherently increases image quality. Planar WB Decision making on the next step SPECT/CT partial scan Evaluation and clinical report creation with Artificial WB Planar and SPECT/CT images WB SPECT/CT Evaluation and clinical report creation with Artificial WB Planar and SPECT/CT images 7

8 Cutting Edge Research Applications After a decade of experience in Multi-PinHole collimation technology in pre-clinical SPECT, Mediso integrated all its benefits to a unique human clinical diagnostic SPECT/CT system. A wide range of research applications are propelled by AnyScan TRIO such as Biomarkers and Receptor Binding in Neurology, Stem Cell research, Cardiology and Drug Discovery, Ligand Development in Oncology. Organ and Disease specific collimators Maximum system performance can be reached with the optimized collimators in Resolution, Sensitivity, Contrast-to-Noise ratio, Acquisition time and Patient comfort PET-like resolution and artifact free image The MPH technology and its higher sampling density of the object resulted in improved resolution and reduced image artifacts. Quantitative SPECT imaging Monte Carlo-based Tera-Tomo 3D SPECT - Q reconstruction models and corrects all physical interactions over gamma particle transport and ensures quantitative results. Stationary SPECT imaging Motionless ( stationary ) gantry provides measurement of physiology in short timeframes in SPECT with precise data acquisition. Dynamic-Gated SPECT Stationary SPECT imaging ensures proper measurement of dynamic processes and takes into account patient motion, heart function and respiration during gated acquisition List Mode SPECT acquisition and software tool Retrieve acquisitions, combine and filter raw data with other physiology parameters: Research and Cardiac clinical applications receive enhanced results Excellent image registration 8 By correcting and compensating the mechanical and electronic misalignment of different modalities the image quality significantly improves

MPH (Multi-PinHole) technology in Neurology and Cardiology MPH technology is used for imaging small objects with gamma camera.

For the TRIO system we have developed different apertures for different clinical applications.

Neurology For Alzheimer disease, the Alzheimer aperture supports homogenous field-of-view for precise analysis of activity distribution or perfusion differences within the brain.

The MPH spiral scanning method has an important feature, which eliminates the dead Brain Region area during the scan.

9 MPH (Multi-PinHole) technology in Neurology and Cardiology MPH technology is used for imaging small objects with gamma camera. The multiple pinholes increase the sensitivity and enhance the angular sampling density of the imaged organ. The camera supports dedicated detector configuration for different types of scans. For the TRIO system we have developed different apertures for different clinical applications. Apertures can be optimized for specific parameters as resolution, sensitivity, field-of-view, homogeneity and CNR (Contrast to-noise Ratio). Neurology For Alzheimer disease, the Alzheimer aperture supports homogenous field-of-view for precise analysis of activity distribution or perfusion differences within the brain. To enhance Parkinson Diagnostics, the Parkinson aperture FOV focuses inside the brain to on the striatal area of the brain and visualizes sub-divisional details in the putamen and caudate nuclei. The MPH spiral scanning method has an important feature, which eliminates the dead Brain Region area during the scan. There is no truncation of the patient scan, the whole brain will be scanned all the time. For brain SPECT 120 degrees is the relative detector position. Cardiology The cardiac aperture can image the full heart in stationary, semi stationary or rotational mode. For the cardiac scan 75 or 90 degree is the relative detector position. Striatum Activity Accuracy Non-AC AC SC No scatter medium Water background Activity background Quantitative SPECT imaging Monte Carlo-based Tera-Tomo 3D SPECT - Q reconstruction includes all physical interactions over gamma photon transportation from the source to the detector and ensures quantitative results. During the SPECT examinations the some of the gamma photons always interact with the human body. Tera-Tomo 3D SPECT Q/MPH algorithms apply scatter and attenuation corrections based on a CT image. Finally the error of measured activity concentration remain be less than 5%. Scatter correction effectively reduces the deteriorating effect of the attenuating medium and restores the quantification. 9

Patient Studies With Multi-PinHole Collimators Patient Studies (LEHR and Alzheimer MP) HMPAO

Reconstruction of the MPH acquisition with Tera-Tomo 3D SPECT MP algorithm Imaging system

Time (min) AnyScan Dua-head SPECT/CT LEHR 128 32 AnyScan TRIO SPECT/CT Alzheimer MP 48 24

phantom Dual-head LEHR SPECT image AnyScan TRIO MPH SPECT image Reference PET image 10 Imaging

10 Patient Studies With Multi-PinHole Collimators Patient Studies (LEHR and Alzheimer MP) HMPAO Brain Perfusion scan Reconstruction of the LEHR acquisition with Tera-Tomo 3D SPECT algorithm Reconstruction of the MPH acquisition with Tera-Tomo 3D SPECT MP algorithm Imaging system Collimator Views Acq. Time (min) AnyScan Dua-head SPECT/CT LEHR AnyScan TRIO SPECT/CT Alzheimer MP Multi-Modality Comparison of the Image Quality with Hoffman 3D Brain Phantom CT image of the phantom Dual-head LEHR SPECT image AnyScan TRIO MPH SPECT image Reference PET image 10 Imaging system Collimator Views Acq. Time (min) AnyScan Dual-head SPECT/CT LEHR 50 MBq Tc-99m 30 AnyScan TRIO SPECT/CT General Purpose MPH 50 MBq Tc-99m 30 AnyScan PET n/a 50 MBq F-18 10

Patient Studies With Multi-PinHole Collimators DaTscan Patient Studies (LEHR and Striatal MPH) SPECT/CT Reconstruction of the LEHR acquisition with Tera-Tomo 3D SPECT algorithm Reconstruction of the

Time (min) Convencional Dual-head SPECT/CT LEHR 128 35 AnyScan TRIO Triple-head SPECT/CT Striatal MPH 48 20 DaTscan Patient Studies (LEHR and Striatal MPH) SPECT+MR 35 minutes acquisition time with

11 Patient Studies With Multi-PinHole Collimators DaTscan Patient Studies (LEHR and Striatal MPH) SPECT/CT Reconstruction of the LEHR acquisition with Tera-Tomo 3D SPECT algorithm Reconstruction of the MPH acquisition with Tera-Tomo 3D SPECT MPH algorithm Imaging system Collimator Views Acq. Time (min) Convencional Dual-head SPECT/CT LEHR AnyScan TRIO Triple-head SPECT/CT Striatal MPH DaTscan Patient Studies (LEHR and Striatal MPH) SPECT+MR 35 minutes acquisition time with LEHR collimator 15 minutes acquisition time with Striatal MPH collimator 45 minutes acquisition time with Striatal MPH collimator Imaging system Collimator Views Acq. Time (min) Convencional Dual-head SPECT+MR LEHR AnyScan TRIO Triple-head SPECT+MR Striatal MP AnyScan TRIO Triple-head SPECT+MR Striatal MP MR T1W MPR TRA ISO 11

Clinical Routine Imaging Monte Carlo based Tera-Tomo -Q reconstruction incudes all physical interactions over gamma photon transportation from the source to the detector and ensures quantitative

Finally the error of measured activity concentration is be less than 5%. Whole Body SPECT Whole Body SPECT can replace the conventional planar WB scans.

12 Clinical Routine Imaging Monte Carlo based Tera-Tomo -Q reconstruction incudes all physical interactions over gamma photon transportation from the source to the detector and ensures quantitative results. During the SPECT examinations the gamma photons are always in interaction with the human body. Tera-Tomo QMPH algorithms apply scatter and attenuation corrections based on a CT image. Finally the error of measured activity concentration is be less than 5%. Whole Body SPECT Whole Body SPECT can replace the conventional planar WB scans. The system generates 3D information from the whole body within near the same acquisition time. Planar views are created from the reconstructed 3D image. Optimized continuous workflow No interruption in the patient scans, no need to make clinical decision in the scanning workflow by the physician. Fast acquisition Thanks to the three heads and the new Tera-Tomo 3D SPECT - Q reconstruction engine 50% less time is needed for the patient scan. Less Administered Dose The triple head system and the new Tera-Tomo 3D SPECT - Q reconstruction engine lead to 50% less dose for the patient. Improved patient comfort Shorter scan time and uninterrupted workflow increases patient comfort while reduces motion artefacts. Patient throughput can be increased significantly. Gantry configuration for Triple-head WB SPECT Detector configuration is flexibly changeable for different type of scans. 120 Degree configurations are optimized for fast WB SPECT acquisitions. Gantry configuration for Dual-head mode 12 The cross-validation of scanning protocols from dual-detector mode to triple-detector mode requires system setup in Dual-head mode. Convencional WB planar scan can also be performed in this mode.

Patient Studies Planar Whole Body scan comparison

acquisition time AP 9 minutes acquisition time PA 9

WB SPECT MIP and WB SPECT fused images 25 minutes

13 Patient Studies Planar Whole Body scan comparison AP 18 minutes acquisition time PA 18 minutes acquisition time AP 9 minutes acquisition time PA 9 minutes acquisition time Whole Body SPECT/CT scan WB SPECT MIP and WB SPECT fused images 25 minutes acquisition time Planar images generated from the WB SPECT 13

Patient Studies Whole Body SPECT/CT Bone

- 12 minutes Myocardial Perfusion scan 3

14 Patient Studies Whole Body SPECT/CT Bone Enhancement image processing Whole Body SPECT Whole Body SPECT with bone enhancement Fast Cardiac Imaging Top row - 3 minutes Bottom row - 12 minutes Myocardial Perfusion scan 3 minutes scantime vs. 12 min scantime Tc99m SestaMIBI, 395 MBq 14

15 Room layout Standard room layout for AnyScan TRIO SPECT/CT Power Supply Requirements Standard room layout for AnyScan TRIO (SPECT/CT/PET) SPECT-component Mains Voltage: 115/230 V (1 phase) Mains frequency: Hz Max. power: 3,0 kva CT-component Mains Voltage : 400/480 V (3 phase) Mains frequency: Hz Max. power: 80 kva (diagnostic CT) 10 kva (non-diagnostic CT) PET-component Mains Voltage: 115/230 V (1 phase) Mains frequency: Hz Max. power: 2.2 kva Environmental Requirements Constant room temperature and humidity rate required for 7 days / 24 hours Room temperature: 20 ± 2º C (68º F ± 3.5º F) Max temperature change rate: 5º C/hour (7º F/hour) Relative humidity: 35-70% non-condensing Atmospheric pressure: kpa Dew point < 17º C (63º F) 15

Conformance Statement Quality management system operated by Mediso Medical Imaging Systems complies with Council Directive 93/42/EEC Annex II.

Medical device design and safety testing has been performed in accordance with EN IEC 60601-1 and EN IEC 60601-1-2 standards.

The technical information provided here is not a detailed specification. For details and up to date information please contact your local distributor or Mediso Medical Imaging Systems.

16 Conformance Statement Quality management system operated by Mediso Medical Imaging Systems complies with Council Directive 93/42/EEC Annex II. The multimodality molecular imaging system was approved by a Notified Body. Product design, development, production and services comply with EN ISO and EN ISO Medical device design and safety testing has been performed in accordance with EN IEC and EN IEC standards. Safety labels are attached to appropriate places on equipment and appear in all operation manuals. The supplied software complies with DICOM standard. The technical information provided here is not a detailed specification. For details and up to date information please contact your local distributor or Mediso Medical Imaging Systems. Trademarks: InterView FUSION, InterView XP, InterView CT AnyScan and Tera-Tomo are trademarks of MEDISO Medical Imaging Systems. MEDISO Medical Imaging Systems info@mediso.com Web: MEDISO GmbH info@mediso.de Web: MEDISO USA sales@medisousa.com Web: MEDISO Pacific PTY LTD. info@medisopacific.com Web: MEDISO Polska Sp. z o.o biuro@mediso.pl Web: MEDISO reserves the right to change data without notice MEDISO Printed in Hungaty ANTR 09/16

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Family IMAGING FOR SCIENCE. nanoscan products are No.1 in the following: the next generation four modality preclinical imaging platform SPECT/MRI, PET/MRI, SPECT/CT, PET/CT nanoscan products are No.1 in the following: - achieve the breakthrough 10,000 cps/mbq SPECT sensitivity