ClearPoint Neuro, a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced that the ClearPoint Prism Neuro Laser Therapy System received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to include 1.5T MRI guidance in addition to the previously cleared 3T MRI guidance.
This expanded labeling could significantly increase ClearPoint Prism’s market opportunity within the United States, where 1.5T MRI systems account for approximately 60% of clinical use. As the Company considers future development within key markets, 1.5T systems represent over 70% of the global installed MRI base, well-positioning ClearPoint Prism for future growth as the company continues to expand internationally.
Related: China-based Surgerii Robotics wins CE mark for single-port surgical robot
“The expanded labeling for ClearPoint Prism is perfect timing for the Company as it delivers added fuel to our 2025 growth initiatives, which we call Fast Forward,” commented Joe Burnett, President & CEO at ClearPoint Neuro. “This product will contribute meaningfully to these goals, both today and tomorrow. In the immediate term, we are excited to bring the benefits of ClearPoint Prism to hospitals that did not have the previously cleared MRI scanner available. As a reminder, our Functional Neurosurgery disposable products, including ClearPoint Prism laser applicators, grew 70% in the first quarter and 33% in the second quarter of this year. That growth was accomplished with one hand tied behind our back as we had access to less than 50% of the neuro LITT market. That hand is no longer tied.”
“The longer-term benefits are more subtle but equally important,” continued Burnett. “As a company, we are still at the very early stages of our biggest value driver in commercial cell and gene therapy delivery. The expanded labeling helps us in this exciting and adjacent market in two ways. First, we gain scale because we will have another product in our commercial bag that will allow us to hire expert clinical specialists into cities that have greater volume, increasing hospital consistency and relationships, while at the same time reducing travel expenses. Second, we believe there is no procedure that surgeons can do clinically today that better mimics a drug delivery procedure than laser ablation. ClearPoint Prism cases cover many different trajectories, are minimally invasive through tiny burr holes, are performed under MRI guidance, and deliver a volume-driven therapy to the patient. Every ClearPoint Prism case a surgical team does today helps them to build a new capability for the exciting future of cell and gene therapy.”
“We’re dedicated to providing our customers an adaptable, forward-thinking system that is designed for a streamlined setup, consistent performance, and optimized surgical workflows,” stated Chris Osswald, PhD, Director and Global Segment Leader for Laser Therapy. “With this clearance, we’ve maintained our high-performance specifications and are well-positioned to build upon our momentum. Since the full market release on 3T MRI last year, we are encouraged by the number of inquiries from sites without 3T access, reflecting strong market interest. We believe surgeons are eager to use ClearPoint Prism on 1.5T, enabling more patients to benefit from advanced laser therapy. Given the significant and positive early experience that we’ve had on 3T, we plan to enter full market release on 1.5T immediately.”
