Toronto, Canada, June 14, 2023 (GLOBE NEWSWIRE) -- Update to Release on Globe Newswire from May 25, 2023 13:30 ET
Vielight announced on Thursday, May 25, 2023 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 regulating drugs and health products to support public safety.
This is a follow-up, revised regulatory-compliant announcement for shareholders and partners.
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. It is not intended to replace other therapies or medical interventions.
“The COVID-19 pandemic has taught us that the option to recover at home is safer for the patient and promotes public health,” said Lew Lim, Ph.D., Founder & CEO of Vielight. We are pleased that Health Canada has granted approval of our technology so we can expand access to this treatment to many Canadians who still contract COVID-19 every week and wish to recover at home.”
The Vielight RX Plus device is the first non-invasive photobiomodulation (PBM) technology to be approved for COVID-19 patients. The device underwent a randomized clinical trial that enrolled 294 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 marks an important step in our ongoing journey to reduce the impact of COVID-19,” said Michael R Hamblin, Ph.D., formerly Associate Professor at Harvard Medical School and now Distinguished Visiting Professor at the University of Johannesburg. “PBM has the potential to play an important role in COVID-19 treatment, making sure that patients have even more access to therapeutic options.”
“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 with clinical partners. “Even as interest in photobiomodulation rapidly grows, we are dedicated to ensuring that this technology 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:
https://medrxiv.org/cgi/content/short/2022.06.16.22276503v1
Information on the Health Canada approval can be found here:
https://health-products.canada.ca/mdall-limh/information?companyId=136815&lang=eng
Research Inquiries
Dr. Nazanin Hosseinkhah
Director of Special Projects
nazanin.h@vielight.com
Media Contact
Peter Adams
peteradams@vielight.com
(416) 710-7140
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
