StellarCube advances global joint research on PainX, its AI pain management solution
IRB approval completed at Johns Hopkins Hospital, launching joint Korea–US clinical research
SourceThe JoongAng (중앙일보)
PainX is the former name of PainCube. This article reproduces the wording used at the time of publication.
StellarCube Inc., an AI health tech company, announced that it has activated a global medical AI research framework spanning Korea and the United States and is advancing development of PainX, its next-generation pain management solution.
StellarCube is conducting joint research with Korea University Anam Hospital, and research on the US side has now begun after Johns Hopkins Hospital completed institutional review board (IRB) approval for the PainX project. An IRB reviews the safety, ethics, personal data protection and methodological validity of research involving patients.
The Johns Hopkins Hospital research team is using a high-resolution biosignal analysis platform based on Sickbay and the EPIC EHR for data collection and model validation. PainX is an AI technology that predicts severe pain 30 to 60 minutes in advance through integrated analysis of high-resolution ECG (≥240 Hz), PPG and ABP (≥120 Hz) and respiratory signals, and is being developed using federated learning across data from both countries.
Korea University Anam Hospital is responsible for the domestic clinical research, covering labeling based on clinical pain indicators such as NRS, CPOT and RASS, and the collection of retrospective and prospective clinical data.
Over the next five years the PainX project aims to raise its technology readiness level (TRL) from 2 to 7 and to obtain FDA 510(k) or De Novo authorization.
On the formal start of the global joint research, the CEO of StellarCube said: "Johns Hopkins Hospital's IRB approval is a very significant achievement, in that a world-leading institution has formally recognized both the need for PainX technology and the ethics and safety of the research."
He added: "We will create a new clinical environment in which AI predicts and prevents pain in advance, and complete a technology that reduces the burden on clinicians while dramatically improving patient recovery", emphasizing PainX's global vision.
According to JHU technical documentation in the United States, if PainX develops into software as a medical device with FDA and MFDS authorization, it could enter a global pain management market worth approximately USD 19.1 billion, with the possibility of applying a reimbursement model of USD 70 per patient through remote patient monitoring (RPM).
With leading medical institutions in both Korea and the United States taking part simultaneously, the PainX project is raising expectations in the global market as an AI technology that implements pain prediction, diagnosis and dosing recommendation on a single platform for the first time anywhere.