ey Highlights

1. What is Micro-Ultrasound?

• A new, real-time imaging modality operating at 29 MHz, offering 70-micron resolution.

• Designed to overcome the limitations of conventional ultrasound (low sensitivity) and MRI (access, cost, claustrophobia, contraindications).

2. Why It Matters

• Real-time imaging of prostate ducts (the origin of most cancers).

• Enables office-based imaging, reducing reliance on expensive or delayed MRIs.

• Can identify cancers missed by MRI, including small or non-contrast-enhancing lesions.

3. Validation & Clinical Trials

• Validated through collaboration with UCLA, UHN Toronto, and others.

• Optimum Study (multi-national, randomized, 680+ patients):

o Proved micro-ultrasound is non-inferior to MRI/ultrasound fusion.

o Micro-ultrasound showed higher sensitivity and NPV than MRI in some cohorts.

• Studies in active surveillance and focal therapy planning also promising.

4. Applications

• Screening men with elevated PSA.

• Performing targeted and systematic biopsies.

• Monitoring patients under active surveillance.

• Guiding focal therapies (e.g., laser, cryotherapy).

• Post-treatment recurrence detection and surgical planning.

5. Training & Usability

• Exact Imaging offers a free, structured training program for physicians.

• Over 300 systems in use worldwide, 100+ in the U.S., many in California.

• Imaging and interpretation primarily performed by urologists, not radiologists, in the U.S.

6. Artificial Intelligence

• AI is in development for image interpretation assistance.

• Partner institutions include UCLA, UBC, University of Florida, and Queens University.

• Focus on making image interpretation easier and more consistent.

7. Commercial Status

• FDA-cleared since 2017.

• Covered under existing ultrasound reimbursement codes.

• Approximate system cost: $200,000, much less than MRI.

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Audience Q&A – Key Themes

• Availability & Reimbursement: Already in clinical use; reimbursed as ultrasound.

• Training Confidence: Robust program ensures urologists achieve diagnostic quality results.

• Imaging Limitations: Cannot yet replace biopsy; histology still required.

• AI & Second Opinions: AI tools and expert reading services developing; referrals possible.

• Testicular Imaging & Other Uses: Promising for testicular pathology and residual volume scans.

• Focal Therapy Implications: May strengthen support for focal therapy as a standard option.

• Awareness & Education Gaps: Group emphasized need for early screening and better public communication (esp. PSA testing in men 50+).

 

 Mentioned

• Website: exactimaging.com

    o Includes physician finder and contact info (info@exactimaging.com)

• Follow-up Studies: MUSIC-AS and MUSIC-Screen (for surveillance and screening)