ClearPoint Neuro Announces Initiation of Limited Market Release for the SmartFrame OR Stereotactic System

More than Ten Operating Room Procedures Complete with Multiple Sites Reordering and Scheduling Cases

SOLANA BEACH, Calif., April 24, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced it has initiated the Limited Market Release for its SmartFrame OR Stereotactic System.

“Expanding ClearPoint’s portfolio beyond the MRI into the operating room is of key strategic significance to the Company in 2024 and beyond,” stated Joe Burnett, President and CEO at ClearPoint Neuro. “We estimate that more than 95% of all stereotactic neuro-navigation procedures take place in the OR, supporting DBS, Laser Ablation, Biopsy, sEEG, and more. This product is the first in ClearPoint’s history that allows for complete procedures to be performed in the operating room, enabling ClearPoint’s access to more hospitals, and to support an order of magnitude more patients than our legacy portfolio. In just the first month of limited market release, we have already completed more than ten cases and all of the active sites have now either reordered product or scheduled additional patients. To put that in perspective, if these hospitals continue on their current pace, then we would have the potential to increase our total, company-wide annual clinical procedure volume by more than 10% from just a handful of active sites. Notably, these are situations where MRI guidance was not a possibility, demonstrating how the new SmartFrame OR product is opening access to a new market opportunity for ClearPoint.”

The SmartFrame OR Stereotactic System is composed of two main components: the SmartFrame OR, and the ClearPointer Optical Navigation Wand. The SmartFrame OR is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction with the use of a compatible optical stereotactic navigation system using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement and electrode introduction. The ClearPointer is intended to be used in conjunction with the SmartFrame OR and a compatible stereotactic optical navigation system for patient registration and navigation. SmartFrame OR may be used with or without available bone screw fiducials. The Company has initiated limited market release, with a planned full market release in the second half of 2024.