Finally, Vielight is ready to commence its clinical trial for COVID-19. The recruitment of subjects for this trial has started in the USA and in Ontario, Canada.
Readers may recall our intention to test the efficacy of our X-Plus device on COVID-19 in April 2020. After five months of intensive preparation by our team of researchers for this clinical trial, we are now ready. We have received all the required approvals to commence our trial. The trial recruitment has started throughout the US, and will start shortly in Ontario, Canada.
This clinical trial involves the use of the Vielight RX Plus, which is a portable photobiomodulation (PBM) device designed for home use. The LED module delivers near infrared light at 810 nm to the thymus gland and lungs, while the nasal applicator delivers 633 nm red light intranasally. In this way the light of both 810nm and 633nm wavelengths is delivered to different parts of the body. The RX Plus has some modifications to the commercially-available X-Plus device, but the design is largely similar.
Due to the pandemic, we are employing safety measures in the clinical trial. For this reason, the trial is managed remotely by clinical trial sites. One such site is located in Port Orange, Florida, USA. The other one is located in Toronto, Ontario, Canada. The trial subjects are monitored remotely over 30 days. The endpoint of the trial is the time for the patients to recover from an infection.
During the past few months, several parties have announced studies involving the use of PBM devices for treating patients infected with COVID-19. There are some differences between our clinical trial and the others. Firstly, the number of test subjects of 280 is far larger, which provides more realistic representation of outcomes in real life. Secondly, this trial is randomized to remove bias. Half of the trial subjects will receive only the usual standard of care, and the other half will additionally use the Vielight RX Plus. The other major difference is that the patients treat themselves at home. The participants are monitored remotely. Full safety protocols are rigorously implemented to remove the risks of human-transmitted spread of the disease.
“Over the years, there have been suggestions that PBM can boost the immune system and control inflammation, based on the data from cell and animal studies. This trial studies human subjects with COVID-19. We await the results to confirm if PBM delivered via the RX Plus is effective in treating COVID-19 infection. Notably, the intervention does not introduce any substance into the body other than the light energy, and this is done in a controlled manner,” said Dr. Lew Lim, Founder & CEO of Vielight. “As always, we seek to apply rigorous scientific study standards to test our hypotheses, and we will manage our expectations pending the final results.”
Information about participation in this clinical trial can be accessed at www.covidlight.ca. The trial has been registered with clinicaltrials.gov and the information about the trial is available there. If you are based anywhere in the US or in Ontario, Canada, please spread the word to help us to recruit the participants for this clinical trial.
Dr. Lim Awarded Worldwide Patent for the Neuro Invention
We have been receiving a lot of love for the Vielight Neuro Alpha, Gamma and Duo since their release a few years ago. Many users have reported that the devices have positively impacted their quality of life with regards to various mental functions and cognition. The award of this patent for the Vielight Neuro invention covers countries around the globe including the USA, Canada, United Kingdom, Europe, China, Japan and Australia. Dr. Lim has assigned the patent to Vielight. Patents covering other territories are pending.
Vielight Welcomes Software Developer, Mark Heydari
We welcome Mark Heydari, a top-level software developer, into our team. Mark is a full-stack developer with over 25 years of experience and a master degree in computer science from the Technical University of Denmark. His skills cover all major computer languages with an impressive record in the field. He will lead the software development work at Vielight, with particular attention paid to the Vielight Neuro Pro apps and backend platform. We expect that with the addition of Mark to our talent pool, we will add more useful and sophisticated offerings to our portfolio of products.