Toronto, Canada, May 25, 2023 (GLOBE NEWSWIRE) — Vielight announced Thursday that its Vielight RX Plus device – which uses near infrared light technology to accelerate the recovery of adults with COVID-19 – has been approved by Health Canada, the federal agency responsible for the nation’s health policy.
This approval by Health Canada represents the first medical device in the agency’s history cleared for quicker recovery from acute COVID-19 infection. The Vielight RX Plus treatment does not require a prescription. It is non-invasive, portable and lightweight, making it convenient for home and travel use.
“If the COVID-19 pandemic has taught us anything, it’s that people prefer to recover at home,” said Lew Lim, Ph.D., Founder & CEO of Vielight. “Our Vielight RX Plus technology strengthens and protects our immune and respiratory systems while suppressing the replication of coronaviruses. We are pleased that Health Canada has granted approval of our technology so we can expand access to this treatment to the thousands of people who still contract COVID-19 every day.”
The Vielight RX Plus device is the first non-invasive photobiomodulation (PBM) technology to be approved based on a review of patient data from a direct clinical trial. It is intended for COVID-19 patients, especially those experiencing acute symptoms within seven days of symptom onset. The Health Canada approval was supported by a randomized clinical trial involving 295 subjects. Vielight collaborated with independent testing labs as well as a contract research organization and other board-certified clinical investigators to conduct the study.
While the urgency of the pandemic has subsided, COVID-19 is still present, causing new infections and severe cases. For the week that ended May 11, 2023, the U.S. Centers for Disease Control and Prevention (CDC) reported a 7-day hospitalization total of more than 9,000 admissions. The CDC also recently reported that nearly one in five people who contracted this disease will later experience symptoms of long COVID.
“This approval is a major endorsement for photobiomodulation,” said Michael R Hamblin, Ph.D., formerly Associate Professor at Harvard Medical School and now Distinguished Visiting Professor at University of Johannesburg. “The body of published research on PBM and coronavirus infection etiology has suggested that PBM may be effective in inhibiting the harmful effects of coronaviruses. It could boost the activities of the immune system while managing the risk of inflammation. PBM is also recognized for its healing properties, which may aid recovery.”
The RX Plus device will retail at $549 USD and is expected to be available within three months for purchase by consumers, practitioners and doctors. “This Health Canada approval is the culmination of our deep commitment to safety and effectiveness,” said Nazanin Hosseinkhah, Ph.D., who managed the Covid-19 study together with clinical partners. “Even as interest in photobiomodulation rapidly grows, we are dedicated to reassuring consumers that this transformative technology, soon to be accessible to them is validated by formal research.”
Dr. Lew Lim adds, “With the advantages of strong in-house research and engineering, coupled with knowledge gained from this clinical trial, we will soon be commencing a new clinical trial to test the effectiveness of our PBM technology for long COVID.”
Further information on the clinical trial can be found here:
Information on the Health Canada approval can be found here:
Additional informaton and multimedia assets including expert interviews can found here:
Dr. Nazanin Hosseinkhah
Director of Special Projects
About Vielight Inc.
Vielight Inc. is a market leader in the field of photobiomodulation (PBM) light therapy research and product innovation. For over a decade, our team of researchers together with our partners from leading universities, healthcare organizations and government agencies have been dedicated to advancing our knowledge of photobiomodulation.
The company is currently conducting several clinical trials to investigate the use of its Vielight PBM devices for Alzheimer’s disease, traumatic brain injury, enhanced brain functions and sports performance. Our patented Vielight PBM devices are available for sale through medical practitioners, doctors and direct to the public.
More information can be found at https://www.vielight.com
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