Approval from Canada\u2019s Top Federal Health Agency Followed Positive Clinical Trial Results<\/h4><\/div><\/div><\/div><\/div><\/div>![](\"https:\/\/www.vielight.com\/wp-content\/uploads\/2023\/05\/X-Plus-3-BODY-front-0281-x2000-800x800.jpg\" "\\"X-Plus")
<\/span><\/div><\/div><\/div>We are honored to announce that the Vielight RX Plus device has received medical device approval from Health Canada!<\/p>\n
We conducted an n=295 clinical trial for Covid-19 recovery for which the results were statistically significant.<\/p>\n
This represents two historic milestones:<\/p>\n
\n- The RX Plus is the first medical device to be approved for the treatment of COVID-19 infection.<\/li>\n
- The RX Plus is the first non-invasive photobiomodulation (PBM) technology to be approved for a major indication.<\/li>\n<\/ol>\n
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.<\/p>\n<\/div><\/div><\/div>
\n- Clinical trial results can be found here: https:\/\/medrxiv.org\/cgi\/content\/short\/2022.06.16.22276503v1<\/a><\/li>\n
- Information on the Health Canada license can be found here: https:\/\/health-products.canada.ca\/mdall-limh\/information?companyId=136815&lang=eng<\/a><\/li>\n
- In the past, we worked with Harvard Medical School on anti-pathogenic research using blue light energy: https:\/\/www.vielight.com\/research\/#anti-viral<\/a><\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div>
The effects of Photobiomodulation on Immunity.\u00a0<\/strong><\/h4>\n(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)<\/p>\n
PBM appears to exert pluripotent effects in the modulation of inflammation and immunity [1<\/a>]. Many studies have demonstrated that PBM modulates inflammation by reducing the pro-inflammatory cytokines (such as IL-1\u03b2, IL-6, IL-8, TNF-\u03b1) and other inflammatory markers released from activated inflammatory cells, while increasing the anti-inflammatory cytokines (IL-10) [2<\/a>]. 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 [3<\/a>], which in turn modulates both ACTH and \u03b2-opioid, as well as, interestingly, ACE activity [4<\/a>].<\/p>\nOne of the central effects of PBM on the immune response is via the modulation of neutrophil function [5<\/a>] by balancing neutrophil numbers, improving neutrophil efficiency and modulating the neutrophil extracellular trap formation [6<\/a>]. Reducing over-accumulation of neutrophils is a major mechanism for the effect of PBM in reducing acute lung inflammation [7<\/a>]. 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 [8<\/a>].<\/p>\nThese 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-\u03b3 [9<\/a>,\u00a010<\/a>]. PBM reduces the number of inflammatory cells, pro-inflammatory cytokines as well as fibrotic tissue in a mouse model of lung fibrosis [11<\/a>]. Acute lung inflammation in rats is reduced with PBM to reduce oedema, neutrophil influx and TNF-\u03b1, while reducing IL-10 in rats [12<\/a>].<\/p>\nIn an experimental model of induced acute peritonitis in rats, Yu and co-workers [13<\/a>] 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 [14<\/a>] 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).<\/p>\nPBM causes mitogenic stimulation responsive lymphocyte proliferation and enhanced lymphocyte ATP synthesis [1<\/a>5]. A plausible mechanism for PBM induced lymphocytic proliferation is through the reaction of light with haemoglobin, resulting in oxygen radical production [1<\/a>6]. Indeed, in immunological cells, PBM induces production of reactive oxygen species, NO or interleukins most often, leading to an anti-inflammatory effect [17<\/a>]. 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 [18<\/a>,\u00a019<\/a>]. 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 [20<\/a>,\u00a021<\/a>].<\/p>\nReference<\/strong><\/p>\n\n- 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.<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":31487,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"bwfblock_default_font":"","inline_featured_image":false,"mc4wp_mailchimp_campaign":[],"footnotes":""},"categories":[3015,2991],"tags":[],"class_list":["post-31455","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-covid-19-recovery-photobiomodulation-device","category-systemic-photobiomodulation"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/posts\/31455","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/comments?post=31455"}],"version-history":[{"count":0,"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/posts\/31455\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/media\/31487"}],"wp:attachment":[{"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/media?parent=31455"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/categories?post=31455"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/tags?post=31455"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
<\/span><\/div><\/div><\/div>We are honored to announce that the Vielight RX Plus device has received medical device approval from Health Canada!<\/p>\n
We conducted an n=295 clinical trial for Covid-19 recovery for which the results were statistically significant.<\/p>\n
This represents two historic milestones:<\/p>\n
- \n
- The RX Plus is the first medical device to be approved for the treatment of COVID-19 infection.<\/li>\n
- The RX Plus is the first non-invasive photobiomodulation (PBM) technology to be approved for a major indication.<\/li>\n<\/ol>\n
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.<\/p>\n<\/div><\/div><\/div>
- \n
- Clinical trial results can be found here: https:\/\/medrxiv.org\/cgi\/content\/short\/2022.06.16.22276503v1<\/a><\/li>\n
- Information on the Health Canada license can be found here: https:\/\/health-products.canada.ca\/mdall-limh\/information?companyId=136815&lang=eng<\/a><\/li>\n
- In the past, we worked with Harvard Medical School on anti-pathogenic research using blue light energy: https:\/\/www.vielight.com\/research\/#anti-viral<\/a><\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div>
The effects of Photobiomodulation on Immunity.\u00a0<\/strong><\/h4>\n
(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)<\/p>\n
PBM appears to exert pluripotent effects in the modulation of inflammation and immunity [1<\/a>]. Many studies have demonstrated that PBM modulates inflammation by reducing the pro-inflammatory cytokines (such as IL-1\u03b2, IL-6, IL-8, TNF-\u03b1) and other inflammatory markers released from activated inflammatory cells, while increasing the anti-inflammatory cytokines (IL-10) [2<\/a>]. 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 [3<\/a>], which in turn modulates both ACTH and \u03b2-opioid, as well as, interestingly, ACE activity [4<\/a>].<\/p>\n
One of the central effects of PBM on the immune response is via the modulation of neutrophil function [5<\/a>] by balancing neutrophil numbers, improving neutrophil efficiency and modulating the neutrophil extracellular trap formation [6<\/a>]. Reducing over-accumulation of neutrophils is a major mechanism for the effect of PBM in reducing acute lung inflammation [7<\/a>]. 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 [8<\/a>].<\/p>\n
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-\u03b3 [9<\/a>,\u00a010<\/a>]. PBM reduces the number of inflammatory cells, pro-inflammatory cytokines as well as fibrotic tissue in a mouse model of lung fibrosis [11<\/a>]. Acute lung inflammation in rats is reduced with PBM to reduce oedema, neutrophil influx and TNF-\u03b1, while reducing IL-10 in rats [12<\/a>].<\/p>\n
In an experimental model of induced acute peritonitis in rats, Yu and co-workers [13<\/a>] 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 [14<\/a>] 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).<\/p>\n
PBM causes mitogenic stimulation responsive lymphocyte proliferation and enhanced lymphocyte ATP synthesis [1<\/a>5]. A plausible mechanism for PBM induced lymphocytic proliferation is through the reaction of light with haemoglobin, resulting in oxygen radical production [1<\/a>6]. Indeed, in immunological cells, PBM induces production of reactive oxygen species, NO or interleukins most often, leading to an anti-inflammatory effect [17<\/a>]. 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 [18<\/a>,\u00a019<\/a>]. 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 [20<\/a>,\u00a021<\/a>].<\/p>\n
Reference<\/strong><\/p>\n
- \n
- 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.<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":31487,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"bwfblock_default_font":"","inline_featured_image":false,"mc4wp_mailchimp_campaign":[],"footnotes":""},"categories":[3015,2991],"tags":[],"class_list":["post-31455","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-covid-19-recovery-photobiomodulation-device","category-systemic-photobiomodulation"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/posts\/31455","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/comments?post=31455"}],"version-history":[{"count":0,"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/posts\/31455\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/media\/31487"}],"wp:attachment":[{"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/media?parent=31455"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/categories?post=31455"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/tags?post=31455"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
- Information on the Health Canada license can be found here: https:\/\/health-products.canada.ca\/mdall-limh\/information?companyId=136815&lang=eng<\/a><\/li>\n
- Clinical trial results can be found here: https:\/\/medrxiv.org\/cgi\/content\/short\/2022.06.16.22276503v1<\/a><\/li>\n