CERAGEM Co. said on the 22nd that the results of a U.S. clinical study conducted based on 28 years of accumulated medical device technology were published in the authoritative international neuroscience journal Frontiers in Neuroergonomics.
The journal is a global publication that covers interactions between human neural responses and bodily functions, and it is an international academic journal that verifies the academic validity and reliability of research through rigorous review.
The study is an international collaborative clinical trial led by researchers at New York University Langone Hospital, which receives top ratings in the U.S. in neurology, together with the NYU Grossman School of Medicine, City College of New York (CCNY), and CERAGEM Co. Clinical. For the first time in the home spinal thermal massager industry, the team conducted a local U.S. randomized controlled trial (RCT) to objectively verify the device's effect.
The study went beyond simple efficacy verification and was conducted based on CERAGEM Co. Clinical's "clinical–regulatory integrated strategy," which proactively reflects the U.S. medical device approval environment and regulatory requirements from the clinical design stage. This is a unique research model that, from the initial planning stage for entry into global markets, simultaneously considers academic value and regulatory compliance.
According to the study, the group that used CERAGEM Co.'s Master V Collection showed overall positive changes, including relief of lower back pain, improved lumbar movement, and a perceived sense of recovery after use. Notably, even after short periods of use, pain relief and bodily relaxation effects were confirmed, indicating potential for everyday condition management. This suggests that CERAGEM Co.'s proprietary technology, which recognizes spinal shape and provides personalized combined stimulation and heat, can contribute to actual bodily recovery beyond simple rest.
Since its founding in 1998, CERAGEM Co. has continuously researched spinal-specialized medical device technology, with its flagship spinal care medical device Master. This clinical study verified that the core drive technology applied to the Master V Collection, which embodies CERAGEM Co.'s 28 years of medical device technology, can deliver muscle pain relief and functional improvement in real-world human application environments. In particular, it is significant that CERAGEM Co.'s proprietary engine-based technology, which precisely recognizes the spine according to human structure and implements combined stimulation and heat, demonstrated effectiveness through scientific study design and was published in an authoritative international journal.
A CERAGEM Co. official said, "This clinical study is meaningful in that medical device technology accumulated over 28 years has been verified for effectiveness and safety in a research environment that meets international standards," and added, "We will expand collaboration with global medical institutions and continue clinical research that considers both scientific evidence and regulatory compliance."