CONFORM Pivotal Trial - Notification of Revised Manual of Procedures

Dear First Name & CONFORM Research Teams,

We are contacting you to provide you with the updated CONFORM Manual of Procedures, revised to align with current CONFORM trial processes. We hope that you find these updates useful and will continue to communicate revisions as they occur.

The following sections were updated:

MOP02 Study Contact List V8.0 20May2025
- Updated to reflect current Conformal Medical personnel
MOP03 Site Personnel Training Requirements V6.0 20May2025
- Added “Regulatory” as a site personnel role
- “Documents Maintained” list on page 1 updated for clarity
- Notes on Lead Echocardiographers on page 2 updated for clarity
MOP10 Protocol Deviations V4.0 20May2025
- Reporting timeline for UADEs updated to reflect protocol requirement (within 2 working days of site awareness)
MOP12 Pre-Procedure Review Process V3.0 20May2025
- Updated to align with newly streamlined process for first 5 cases
- Live meeting required only for review of first case
- FAQ updated for clarity
MOP12 Appendix A: Site Template - CONFORM Pre-Procedure Imaging Review Process Example V5.0 05Mar2025
- Updated alongside MOP12 to align with newly streamlined process for first 5 cases
- Sites no longer required to embed images in pre-procedure review PowerPoint file

The following new section was added:

MOP14 Submitting Planned/Scheduled Case V1.0 20May2025
- Detailed instructions for using the CONFORM Trial Case Scheduler

A combined PDF of the full Manual of Procedures, as well as individual PDFs of each section, are available for download on the CONFORM Research Coordinator Portal here. Please note that a revised hard copy will not be sent to your site.

Please reach out to your assigned Site Manager with any questions about the updates. Thank you for your continued efforts toward the CONFORM Pivotal Trial. We couldn’t do this without you!

Regards,

Aly Dechert | Manager of Clinical Operations

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Use the login:

AcuFORM2025!

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Drop us a note at info@conformalmedical.com.

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