ClearPoint Neuro, Inc. reported a total revenue of approximately $31.4 million for the fiscal year ending December 31, 2024, marking a 31% increase from $24.0 million in 2023. The growth was primarily driven by a significant rise in product sales, particularly from the ClearPoint system and related disposable products, which saw a 76% increase to $18.6 million. Service revenue, however, experienced a slight decline of 4%, totaling $12.8 million. The company also reported a net loss of $18.9 million, an improvement from the $22.1 million loss in the previous year, reflecting a 14% reduction in losses.

In terms of operational developments, ClearPoint Neuro activated 25 new global centers in 2024, contributing to increased demand for its products, including the recently launched SmartFrame OR Stereotactic System and the ClearPoint Prism Neuro Laser Therapy System. The company has established partnerships with over 60 pharmaceutical and biotech firms, which are currently evaluating or utilizing its products in clinical trials. This expansion is indicative of ClearPoint's strategic focus on enhancing its market presence and product adoption in the neurosurgery and drug delivery sectors.

The company has made notable advancements in regulatory approvals, receiving 510(k) clearance from the FDA for the SmartFrame OR Stereotactic System and De Novo marketing authorization for the SmartFlow cannula, which is used for gene therapy delivery. These approvals are expected to bolster ClearPoint's competitive position in the market. Additionally, the company has reduced its cash used in operations to $9.0 million in 2024, a 35% decrease from the previous year, signaling improved operational efficiency.

Looking ahead, ClearPoint Neuro anticipates continued growth driven by increased utilization of its products and services, particularly in the biologics and drug delivery space. The company plans to leverage its existing partnerships and expand its customer base to enhance revenue streams. However, it acknowledges potential risks, including economic conditions, customer concentration, and the need for ongoing regulatory compliance, which could impact future performance. The company remains focused on its long-term strategy to achieve profitability while navigating the complexities of the medical device market.

About ClearPoint Neuro, Inc.

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