MedRelief is performing extensive
basic science research primarily using in vitro studies with cell
types such as osteoblasts and chondrocytes. Data from our cartilage
cell studies shows early release of chemicals known to have a pain
relieving effect on biological systems. Data from bone cell studies
point to two findings; (1) a large increase in critical growth factors
in the formation of bone; and (2) the production and organization,
of mineralized bone tissue.
In order to gain the most comprehensive clinical data, our testing
includes a range of studies from case studies; to uncontrolled pilot
studies; to randomized, controlled, blinded trials.
• Case studies – individual and small
groups used of MedRelief pain device showing reduction of pain for
most patients
• Uncontrolled pilot studies – larger
groups of 10 to 20 subjects showing successful pain reduction and
patient compliance
• Randomized controlled clinical trials
– large scale studies (around 100 subjects in multi-centered
trials) designed to acquire definitive data to support additional claims
In pain relief applications, we want to establish clear effectiveness
in specific painful conditions and potentially obtain additional
labeling claims. For other healing applications, we will conduct
basic, applied and clinical research as necessary to gain further FDA clearance.
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