What ClearPoint Neuro, Inc. told the SEC could break it.

ClearPoint Neuro depends on a small number of customers: its five largest hospital customers accounted for approximately 21% of its neurosurgery navigation disposable product revenues in 2025, and within biologics & drug delivery one partner — PTC Therapeutics — represented about 15% of that segment's revenue; because revenues from almost all customers are not based on long-term, committed volume purchase contracts, the loss of, or reduced purchasing by, a major hospital or PTC could cause its revenues to fluctuate significantly.

“Our five largest hospital customers accounted for approximately 21% of our neurosurgery navigation disposable product revenues in 2025.”

ClearPoint relies on single-source suppliers for key products: the ClearPoint Prism Neuro Laser Therapy System is manufactured exclusively by and supplied by CLS (a single-source supplier that itself depends on single-source suppliers for components/subassemblies), and it sources the catheters and procedure-specific disposables for its IRRA flow system from single-source suppliers, without currently maintaining multiple qualified suppliers for all of these products; a disruption at CLS or these single-source suppliers could interrupt product availability and materially harm its business.

“The ClearPoint Prism Neuro Laser Therapy System is supplied to us by CLS, and we rely on CLS as a single-source supplier for this product.”

ClearPoint conducts many of its activities — research and development, component processing, final assembly, packaging and distribution for most products — at facilities in Southern California (Solana Beach/San Diego) and does not have redundant facilities; Southern California is a seismically active area that has experienced major earthquakes and is prone to wildfires, so an earthquake, wildfire, pandemic, cyberattack or other catastrophe at these single-region sites could halt manufacturing and distribution and materially disrupt its business.

“We conduct many of our activities, including research and development, component processing, final assembly, packaging and distribution activities for most of our products, at our facilities located in Southern California, which is a seismically active area that has experienced major earthquakes in the past, as well as other natural disasters, including wildfires.”

ClearPoint is subject to extensive medical-device regulation: if it or its third-party suppliers fail to comply with the FDA's Quality Management System Regulation (QMSR) or state equivalents, its manufacturing could be interrupted; it also faces off-label-promotion liability, must obtain and maintain device clearances/approvals (e.g., EU MDR certification and clearances across 34 countries), and its sales depend in part on third-party payors (Medicare, Medicaid and private payers) covering and reimbursing procedures using its devices — so regulatory or reimbursement setbacks could materially reduce demand and disrupt operations.

“If we or our third-party suppliers fail to comply with the FDA's Quality Management System Regulation (“QMSR”) or any applicable state equivalent, our manufacturing operations could be interrupted, and our potential product sales and operating results could suffer.”