Following a clinical trial to evaluate a COVID-19 application of its laser therapy, Multi Radiance Medical, a Solon-based medical device company, is preparing to apply for emergency use authorization with the U.S. Food and Drug Administration (FDA).
The triple-blind, placebo-controlled clinical trial evaluated the use of the company’s super pulsed laser therapy technology to improve respiratory function in critically ill COVID-19 patients who have been placed on ventilators.
Patients on ventilators often suffer a weakened diaphragm, said Douglas Johnson, senior vice president of clinical and scientific affairs for Multi Radiance Medical.
“When these patients are intubated, they end up having a weakened diaphragm,” he said. “So by the time they get to day five or day six, their diaphragm is atrophying. It’s getting smaller; it’s loosing muscle mass. And the problem with that is that when they try to take them off it, the muscle that causes them and allows them to breathe is now weak. So these people come off and they stay in respiratory distress and they have to have supplemental oxygen.”
The clinical trial examined how the laser therapy can preserve and improve the thickness of the diaphragm in ventilated COVID-19 patients. Results show that the company’s therapy decreased invasive intubation time/need overall by 18%, and decreased mechanical ventilation time/need by 23% overall, according to a news release.
In the United States, Multi Radiance Medical’s technology has largely been used for pain management, but it has been approved for different applications in other countries.
Knowing the company’s previous peer-reviewed research in various applications (such as stroke and sports performance), researchers approached Multi Radiance Medical about this COVID-19 trial.
Even before the pandemic, the company was exploring the use of its technology in pulmonary applications, including publishing a study of its effectiveness in chronic obstructive pulmonary disease (COPD).
“This could potentially open entirely new markets and significant opportunities for our company,” said Max Kanarsky, president and CEO of Multi Radiance Medical.
The company has been growing in recent years, he said, noting double-digit growth in revenues last year and its considerations of further international expansion.
“We are investing in clinical research and therefore creating new applications and new markets for ourselves,” Kanarsky said. “And that’s what we’ve been doing over the last seven years or so. We have over 50 clinical studies done, so it’s quite a bit of work, a lot of effort, a lot of investment going into validating our technology and also demonstrating efficacy in new applications and new conditions as well, which go beyond musculoskeletal conditions.”
The technology uses light therapy to treat patients at the cellular level, and help cells recover from damage sustained from a variety of issues.
“So the reason it can have such a strong impact is that it’s a cellular type of therapy, where it’s not really just a target or an organ-specific type of thing,” Johnson said. “It really focuses on helping the cell to recover from whether it’s inflammation or an infection or damage.”
Multi Radiance Medical says the trial is the first of its kind to evaluate a non-pharmaceutical medical device with “virtually no side effects” that could benefit patient health outcomes, according to the release.
“We know that the vaccines are coming, but it’s not doing anything for the patients that are going to have severe cases,” Johnson said. “We can actually reduce the amount of time they need the vent and the time that they’re in the hospital. This is going to help reduce a lot of the health care burden that we’re seeing. Let’s take some of that pressure off our health care workers right now.”
