Preliminary Results of 27,659 patients from MOSAIC Trial Demonstrate that Proove® Technology Leads to Better Patient Outcomes
IRVINE, Calif., May 31, 2017 /PRNewswire/ — Proove® Biosciences, Inc. announces preliminary results at the close of a large patient-centered outcomes clinical trial demonstrating 94% of patients experience a significant pain reduction within 60-days of treatment changes informed by Proove®.
This trial entitled, Multicenter Longitudinal Observational Study Evaluating Genotypic Association with Clinical Outcomes in Interventional Pain Management Modalities (M.O.S.A.I.C.), was approved by an institutional review board (IRB) licensed by the Office of Human Research Protections (OHRP) at the Department of Health & Human Services (HHS). The study has been listed on the National Library of Medicine’s website, www.ClinicalTrials.gov (NCT Identifier: NCT02485795). Dan Kendall, D.O. of leading pain center, National Spine & Pain Centers (NSPC), served as the initial Principal Investigator where 11,605 study participants were enrolled at 32 NSPC locations, and Maneesh Sharma, M.D. of the Interventional Pain Institute of Baltimore served as the final principal investigator of the trial for a total of 27,659 enrolled participants across 170 sites.
Here is a brief results summary:
- Following treatment decisions informed by Proove®, 94% of patients reported an average pain reduction of 43% within 60 days — far exceeding FDA’s requirement for pain relief;
- Average pain numerical rating scale (NRS) before Proove®-guided treatment was 7.7, and the average after was 4.4.
- Over 77% of patients responded favorably to medication changes implemented based on Proove® profiles.
- Results also show Proove®-guided treatment led to an appropriate reduction in opioid utilization, as 13.8% of patients reported taking less opioid medications following Proove® profiles, resulting in no significant difference in pain relief between opioid and non-opioid alternatives (p=0.87).
Concluding Principal Investigator, Dr. Sharma explains, “Proove® profiles provide assessments regarding pain sensitivity, opioid abuse risk, and treatment response. It’s important to evaluate how this information is used by a clinician and more importantly, whether it helps clinicians make better treatment decisions. We look forward to publishing the results of this ground-breaking study.”
Senior Director of R&D at Proove®, Dr. Svetlana Kantorovich, states “The M.O.S.A.I.C. Trial demonstrates prospective real-world evidence that Proove®’s technology helps clinicians make better decisions and substantially improves patient outcomes in the nation’s most prevalent and expensive health condition.”