ExactVu brochure 2023

29MHz Micro-Ultrasound
for targeted prostate biopsies
Micro-Ultrasound Technology
A new era in urological imaging
See.
Characterize.
Target.

29MHz Micro-Ultrasound
for targeted prostate biopsies

Micro-Ultrasound Technology
See.
Conventional, Micro-Ultrasound, and MRI of the same prostate
Conventional Ultrasound
29 MHz Micro-Ultrasound mpMRI
No abnormality on
conventional ultrasound
(isoechoic)
Most [Prostate] ducts are too
small to be visualized under
conventional US, but can be
visualized under microUS.”
Pensa J, et al. EMBC 2022
PRI-MUS 4 Mottled
appearance on MicroUS
The 1 st and only
system to operate
at 29 MHz
No abnormality
on T2 MRI
In 1040 subjects at 11 sites,
micro-ultrasound had
significantly higher sensitivity
than mpMRI (94% vs 90%).”
Klotz et al. Canadian Urological
Association Journal 2020
Site of 4+3 prostate cancer (80% pattern 4 with extensive cribiforming)

Characterize.
PRI-MUS PRI-MUS : : Prostate : : : Prostate risk identification risk identification using using micro-ultrasound
PRI-MUS : Prostate SYSTEMATIC BIOPSY SYSTEMATIC Risk BIOPSY Identification using TARGET Micro-UltraSound
SUSPICIOUS TARGET REGION
SUSPICIOUS REGION
…a clear increase was noted in risk of significant cancer with PRI-MUS score... Positive Predictive Value for csPCa ranged from 4.4% (PRI-MUS 1) to 71.4% (PRI-MUS 5).”
11
11
1 22
22
2 33
33
3 44
44
4 55
55
5
Luger F. et al. Annal Urol & Nephrol. 1(4): 2019
PRI-MUS 1
PRI-MUS 11
1
PRI-MUS 2
2
PRI-MUS 22
2
PRI-MUS 3
3
PRI-MUS 3 3
PRI-MUS 4
4
PRI-MUS 4
4
PRI-MUS 5
5
PRI-MUS 55
PRI-MUS 1 PRI-MUS 2 PRI-MUS 3 PRI-MUS 4 PRI-MUS 5
1 1 “Swiss Cheese” 1 1 1 “Swiss Cheese” 2 2 Hyper, ductal 2 2 2 patches Hyper, ductal patches 3 Mild 3 Mild hetero, 3 Mild 3 bright Mild 3 Mild echoes hetero, bright 4 4 echoes Bright Echoes 4 4 4 Bright Echoes 5 5 Irregular Shadowing
5 5 5 Irregular Shadowing
in in hyper tissue in in in hyper tissue
(“Starry Sky”)
(“Starry Sky”)
Benign
Benign
Benign
Benign
Benign
Benign
Gleason 8 8
Gleason 8 8 8
Gleason 7 7
Gleason 7 7 7
1 1 “Swiss Cheese” 1 1 1 “Swiss Cheese” 2 2 Hyper, ductal 2 2 2 patches Hyper, ductal patches 3 Mild 3 Mild hetero, 3 Mild 3 bright Mild 3 Mild echoes hetero, bright 4 4 echoes “Cauliflower” 4 4 4 “Cauliflower”
in in hyper tissue in in in hyper tissue
5 5 Mixed Echo 5 5 Lesion 5 Mixed with
with Echo Echo Lesion with with with
Irregular Prostate Irregular border
Prostate border
Benign
Benign
Benign
Benign
Gleason 7 7
Gleason 7 7 7
Gleason 8 8
Gleason 8 8 8
Gleason 9 9
Gleason 9 9 9
1 1 “Swiss Cheese” 1 1 1 “Swiss Cheese” 2 2 Hyper, ductal 2 2 2 patches Hyper, ductal patches 3 Mild 3 Mild hetero, 3 Mild 3 bright Mild 3 Mild echoes hetero, bright 4 4 echoes “Smudgy/Mottled” 4 4 4 “Smudgy/Mottled” 5 5 Hypoechoic 5 5 Lesion 5 Hypoechoic with with
Lesion with with with
in in hyper tissue in in in hyper tissue
Irregular Prostate Irregular border
Prostate border
Benign
Benign
Benign
Benign
Gleason 7 7
Gleason 7 7 7
Gleason 7 7
Gleason 7 7 7
Gleason 8 8
Gleason 8 8 8
1 1 “Swiss Cheese” 1 1 1 “Swiss Cheese” 2 2 Hyper, ductal 2 2 2 patches Hyper, ductal patches 3 Mild 3 Mild hetero, 3 Mild 3 bright Mild 3 Mild echoes hetero, bright 4 4 echoes Bright Echoes 4 4 4 Bright Echoes 5 5 Mixed Echo 5 5 Lesion
5 Mixed Echo Echo Lesion
in in hyper tissue in in in hyper tissue
(“Starry Sky”)
(“Starry Sky”)
Benign
Benign
Benign
Benign
Gleason 7 7
Gleason 7 7 7
Gleason 7 7
Gleason 7 7 7
Gleason 7 7
Gleason 7 7 7
* The initial PRI-MUS protocol was validated with data from 400 micro-ultrasound biopsy-based cineloops matched to pathological results. The accompanying study has been published in the Journal of Urology: Ghai, S. et al.,
“Assessing Cancer Risk in Novel 29 MHz Micro-Ultrasound Images of the Prostate: Creation of the Protocol of Prostate Risk Identification Using Micro-Ultrasound”, Journal of Urology, Paper In Press: June 2016
Reference: Ghai, Ghai, S. et S. al., et Reference: al., “Assessing Ghai, Ghai, Ghai, S. et S. Cancer et al., S. al., et Risk al., Risk “Assessing on on Novel Novel Cancer 29 Cancer 29 MHz Risk MHz Risk on Risk on Micro-Ultrasound Novel on Novel Novel 29 29 MHz 29 MHz MHz Images Micro-Ultrasound of of the the Prostate: Images of Creation of the the of of the of the Prostate: the Micro-Ultrasound Creation of of the the of the Protocol Micro-Ultrasound for for Prostate Risk Protocol Risk for Identification”, for for Prostate Risk Risk Journal Risk of Identification”, of Urology, 2016 2016 Journal of Aug;196(2):562-9
of of Urology, 2016 2016 2016 Aug;196(2):562-9

Target.
One probe, Two approaches for TARGETED PROSTATE BIOPSIES
TRANSRECTAL APPROACH
TRANSPERINEAL APPROACH
In targeted biopsies micro-ultrasound biopsy
cases presented higher detection of clinically
significant disease (Gleason score greater
than 6) than the robotic ultrasound magnetic
resonance imaging fusion biopsy group (38%
vs 23%, p[0.02)).”
Claros OR, et al. J Urol. 2020 May 10;203(5):918–925

ExactVu Mastery Program
Becoming an expert in micro-ultrasound
ENROLLMENT
• Tell us you would like to participate
INDEPENDANT CASES
• Record your information as per
the provided Workflow Guidance
FEEDBACK REPORT
• Wait 1 – 2 weeks for your
tailored feedback report
1 2
3 4 5
INITIAL LEARNING CURVE
• Complete the E-Learning modules
• Complete 10–15 cases with expert support
UPLOAD
• Wait for pathology reports
• Upload – Anonymized Worksheets, Cines
and Pathology reports to the secure link
On-Going ExactVu Feedback Reports
Exact Imaging provides ongoing reports to help each practitioner and
each practice understand the successful usage of the ExactVu system.
Committed to Your Success
Exact Imaging’s Comprehensive Training Program is offered with every
sale of an ExactVu instrument. We are committed to ensuring that all
users of the ExactVu system receive ongoing feedback to ensure optimal
use of the Micro-Ultrasound system — and ultimately to monitor the
improvement in detection rate and patient outcomes.

29MHz Micro-Ultrasound
for targeted prostate biopsies
Micro-Ultrasound / MRI Fusion

See.
Visualize prostates of any size with
300% improvement in resolution.
Characterize.
Use a validated, published protocol
to discern level of suspicion.
Target.
Use advanced visualization to ensure
the lesion has been sampled properly.
contact@edap-tms.com
References:
ExactVu Micro-Ultrasound Imaging System with Single EV29L Transducer – 252129 (Japan 252132)
Disposable sterile transperineal needle guide – 251067
Disposable sterile transrectal needle guide – 251065
BRO-107A - March 2023 - ExactVu, Exact Imaging, PRI-MUS, FusionVu, Cognitive Assist and ExactVu Micro Doppler are trademarks of Exact Imaging. The ExactVu micro-ultrasound system is a medical device for physician use only and intended for
diagnostic ultrasound imaging. The ExactVu micro-ultrasound imaging platform is a tool for urologists to perform targeted biopsies of the prostate. Please consult Instructions for Use. It is available for sale in the European Union via conformity assessment performed by BSI
(Class IIa - CE 2797), within the United States (FDA 510(k) clearance), and within Canada (Health Canada license). Please contact your local Sales Representative to learn more about the Exact Imaging products that are registered and available for sale in your region.