With hospitalizations rapidly rising as the COVID-19 pandemic washes across the world in a winter wave, researchers are racing to develop treatments that protect the increasing number of ventilated patients. One option focuses on protecting muscles critical to breathing. About half of patients who require mechanical ventilation for more than three or four days experience thinning of the diaphragm, which extends the time they stay on ventilation and worsens their outcomes.
Multi Radiance Medical Inc. (MRM), based in Solon, Ohio, may have a solution. A clinical trial published to the preprint medRxiv server Dec. 2, 2020, demonstrated that the company’s Photoxyl device preserved and improved diaphragm thickness in mechanically ventilated COVID-19 patients and decreased time on invasive intubation 18% overall and on mechanical ventilation by 23%. MRM is applying for emergency use authorization for the photoceutical device, which uses noninvasive super pulsed laser therapy.
“As vaccines are being developed to prevent disease spread, we need to find better ways to care for critically ill patients,” noted Max Kanarsky, MRM founder and CEO. “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.”
Clinical trial results
The placebo controlled, randomized, triple blinded, single center study enrolled 30 critically ill COVID-19 patients who required intensive care and mechanical ventilation, including intubation. The patients receiving the pulsed light therapy had nearly 46% thicker diaphragms following daily treatment than controls.
“Increased thickness of the diaphragm has been associated with improved respiratory function and increased vital capacity over time,” said 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.”
In the trial, investigators directed light energy from the Photoxyl device to eight locations, six in the abdomen and two in the neck. Patients received one minute of light therapy to each location, for a total treatment time of eight minutes, once a day throughout their stay in the ICU. The treatment targets the bilateral sternocleidomastoid and the diaphragm.
Patients received the treatment in the supine position. The noninvasive therapy can be administered by respiratory or physical therapist or nursing staff.
“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,” said Douglas Johnson, MRM senior vice president of Clinical and Scientific Affairs.
Boosting cellular metabolism
Photoxyl light energy is comprised of several different wavelengths that previous MRM research showed upregulated mitochondrial functioning.
“When photons of light energize the metal sites in the mitochondrial complex IV (cytochrome c oxidase - CCO), it led these complexes alter both the conformation of the enzyme and redox reaction,” Johnson told BioWorld. “This increases the electron transfer in the respiratory chain and/or pumping of protons across the inner mitochondrial membrane. The increase in the transfer of protons and electrons accelerates the oxidative metabolism leading to an increase in ATP, which in turn promotes an increase in cellular metabolism.”
As decreased ATP is a factor in muscle fatigue, the researchers hypothesized that boosting it could protect respiratory muscle function.
Photoxyl was derived from MRM’s original technology, Activ Pro, which has U.S. FDA clearance for treatment of neck and shoulder pain. The company has previously studied the use of pulsed laser therapy on knee pain, knee osteoarthritis, fibromyalgia, low back pain, temporomandibular joint dysfunction, and total hip arthroplasty in 15 clinical trials on nearly 500 subjects.
The company’s super pulsed laser therapy uses three wavelengths, 660 nm, 875 nm, and 905 nm, for optimal tissue saturation. A proprietary algorithm synergizes the wavelengths creating a cascading effect that enables deeper penetration and reduces cellular interference with low thermal impact on tissues.