SpineMatrix, Inc.

SpineMatrix®, Inc. (SMI) is a spinal imaging company that has developed the CERSR® imaging system for evaluating low back physiology related to the origin of low back pain (LBP) and injury. CERSR® aids the physician in accurately diagnosing the true source of LBP with the very real potential to significantly reduce total health care costs and significantly improve patient care by directing the LBP patient to the appropriate diagnostic and therapeutic procedures. CERSR® is FDA cleared. SMI has completed clinical efficacy studies at The Cleveland Clinic, the Texas Back Institute, Ohio State University College of Medicine and others on muscle, facet and disc pathology. Analysis of the data showed CERSR® is clearly able to differentiate patients who will respond to facet pathology treatment (95% sensitivity) and disc pathology treatment (88% sensitivity) procedures from those who will not respond to these painful, expensive, invasive procedures.

The Need

Low back pain is the most common and most costly non life-threatening disease affecting the industrialized world. At the present time, there is no effective soft tissue diagnostic modality to adequately assist the physician in the diagnosis, treatment and monitoring of patients who suffer from chronic LBP. Current diagnostic procedures include X-ray, MRI and CT tests which give the physician information related to the lower back anatomy. However, there are no effective diagnostic procedures which reliably provide the physician with the physiology of the lower back, which is necessary to determine the source of lower back pain and the associated proper treatment path. Antiquated facet joint injections and discograms are often used to aid the physician with the diagnosis, but these painful, costly and invasive procedures involve risk and side effects while being ineffective up to 50% of the time.

In most medical conditions, a physician relies on both anatomy and physiology to make a diagnosis. For example, in the case of a possible heart attack, the attending physician will take a patient history, perform a chest X-ray for anatomy, and perform an EKG for physiology of the heart, prior to making a diagnosis. In the current environment, a patient presenting with LBP will undergo a medical history and either X-ray or MRI for lower back anatomy but no reliable diagnostic test for evaluating low back physiology that supports and mobilizes the entire spinal column and process. CERSR® provides definitive physiological data that aids the physician in more accurately diagnosing LBP and in directing appropriate care. CERSR® is non-invasive (versus painful needle EMG, discograms or facet joint injections) and provides the physician and patient with rapid, low-cost, point-of-care conclusive images. SMI has recently leveraged $9.5M for R&D, FDA and other regulatory clearances, clinical studies and granted domestic and international intellectual property.