Approval from Canada’s Top Federal Health Agency Followed Positive Clinical Trial Results

We are honored to announce that the Vielight RX Plus device has received medical device approval from Health Canada!

We conducted an n=295 clinical trial for Covid-19 recovery for which the results were statistically significant.

This represents two historic milestones:

  1. The RX Plus is the first medical device to be approved for the treatment of COVID-19 infection.
  2. The RX Plus is the first non-invasive photobiomodulation (PBM) technology to be approved for a major indication.

The RX Plus combines our patented red and near-infrared light technology to accelerate the recovery of adults with COVID-19. We designed it to be non-invasive, portable, and lightweight to meet the needs of those who prefer to recover at home or on-the-go.

The effects of Photobiomodulation on Immunity. 

(The text below is based on an article from Liebert A, Bicknell B, Markman W, Kiat H. A Potential Role for Photobiomodulation Therapy in Disease Treatment and Prevention in the Era of COVID-19. Aging Dis. 2020 Dec 1;11(6):1352-1362. doi: 10.14336/AD.2020.0901. PMID: 33269093; PMCID: PMC7673843)

PBM appears to exert pluripotent effects in the modulation of inflammation and immunity []. Many studies have demonstrated that PBM modulates inflammation by reducing the pro-inflammatory cytokines (such as IL-1β, IL-6, IL-8, TNF-α) and other inflammatory markers released from activated inflammatory cells, while increasing the anti-inflammatory cytokines (IL-10) []. The immuno-modulatory effect of PBM on cytokines regulation and the complement cascade occurs via the POMC pathway, involving regulation of the hypothalamic pituitary axis through the direct modulation of the POMC/melanocortin signalling pathway including a-MSH, a potent anti-inflammatory molecule. The POMC pathway is regulated by PBM [], which in turn modulates both ACTH and β-opioid, as well as, interestingly, ACE activity [].

One of the central effects of PBM on the immune response is via the modulation of neutrophil function [] by balancing neutrophil numbers, improving neutrophil efficiency and modulating the neutrophil extracellular trap formation []. Reducing over-accumulation of neutrophils is a major mechanism for the effect of PBM in reducing acute lung inflammation []. This is crucial in preventing the cytokine storm cascade in autoimmune diseases. PBM also modulates the ratio of M1 and M2 macrophage phenotypes, reducing pro-inflammatory cytokines and chemokines and increasing anti-inflammatory cytokines and thus balance the inflammatory process [].

These inflammatory changes facilitated by PBM have profound effects on many body processes. For example, PBM therapy has been shown to modulate peripheral blood mononuclear cells and CD4+ cells to reduce inflammatory effects in multiple sclerosis patients and healthy adults by increasing IL-10 and reducing IFN-γ [, ]. PBM reduces the number of inflammatory cells, pro-inflammatory cytokines as well as fibrotic tissue in a mouse model of lung fibrosis []. Acute lung inflammation in rats is reduced with PBM to reduce oedema, neutrophil influx and TNF-α, while reducing IL-10 in rats [].

In an experimental model of induced acute peritonitis in rats, Yu and co-workers [] showed PBM resulted in lymphocyte proliferation and enhanced lymphocyte ATP synthesis compared to controls, and the 60-day survival rate of the PBM group was double that of the control group (p<0.001). Assis et al [] further demonstrated the immune modulation capability of PBM, with septic rats treated with PBM exhibiting lower IL-6 activity and decreased atrogin-1 and MuRF-1 immuno-expression (markers of sepsis related muscle catabolic states).

PBM causes mitogenic stimulation responsive lymphocyte proliferation and enhanced lymphocyte ATP synthesis [5]. A plausible mechanism for PBM induced lymphocytic proliferation is through the reaction of light with haemoglobin, resulting in oxygen radical production [6]. Indeed, in immunological cells, PBM induces production of reactive oxygen species, NO or interleukins most often, leading to an anti-inflammatory effect []. It is well documented that various immune response processes are highly dependent on cellular energy, the latter being depressed in sepsis and septic shock cases [, ]. The mitochondria probably act as photo-acceptors for PBM and robustly reactivate cellular energy synthesis to re-establish ATP levels in a variety of cells including lymphocytes and macrophages, and through several pathways that trigger activation of nucleic acid synthesis and cellular proliferation [, ].

Reference

  • Liebert A, Bicknell B, Markman W, Kiat H. A Potential Role for Photobiomodulation Therapy in Disease Treatment and Prevention in the Era of COVID-19. Aging Dis. 2020 Dec 1;11(6):1352-1362. doi: 10.14336/AD.2020.0901. PMID: 33269093; PMCID: PMC7673843.