After completing a clinical trial evaluating its super pulsed laser therapy technology to improve respiratory function in critically ill COVID-19 patients, medical device manufacturer Multi Radiance Medical (MRM) prepares to apply for emergency use authorization with the Food and Drug Administration (FDA).
The triple-blind, placebo-controlled clinical trial evaluated how the company’s super pulsed laser therapy technology preserves and improves the diaphragm’s thickness in COVID-19 patients who have been placed on ventilators.
The trial results show that MRM super pulsed laser therapy decreased invasive intubation time/need by 18% overall and decreased mechanical ventilation time/need overall by 23%.
“Increased thickness of the diaphragm has been associated with improved respiratory function and increased vital capacity over time,” says Dr. Ernesto Leal-Junior, MRM Lead Researcher. “This is the first clinical evidence that super pulsed laser therapy can significantly improve the ARDS symptoms of the critically ill.”
The trial is the first of its kind to evaluate a non-pharmaceutical medical device with virtually no side effects, which could greatly benefit patient health outcomes.
“These results show that our novel photoceutical device lessens the amount of time mechanical ventilation is needed—reducing the risks associated with prolonged use. Less need frees up equipment and beds for other patients,” says Douglas Johnson, MRM Senior Vice President of Clinical and Scientific Affairs.
Researchers approached MRM about the trial due to its extensive previous peer-reviewed research in COPD, stroke, sports performance, and other health conditions. MRM plans to apply for the FDA’s emergency use authorization to approve and distribute the product quickly to hospitals treating COVID-19 patients.
“As vaccines are being developed to prevent disease spread, we need to find better ways to care for critically ill patients. The promising trial results show that MRM super pulsed laser therapy technology can provide a new way to reduce the side effects often experienced during lifesaving intubation,” says Max Kanarsky, MRM Founder and CEO.
Source: Multi Radiance Medical