Woodstock-based biomedical company SoftWave Tissue Regeneration Technologies recently announced a clinical trial that is now underway to help reduce complications from acute traumatic spinal cord injuries.
Chief Strategy Officer Wayne Spencer of SoftWave Tissue Regeneration Technologies said that the trial will help to treat issues resulting from a spinal cord injury, such as swelling and inflammation.
“The theory for this trial is that our device will help decrease the swelling and inflammation around the injury,” Spencer said. “Swelling is what causes a great deal of the long term problems with the injury, and our device can decrease the swelling almost immediately. Our hope is that the prognosis would hopefully be much better than what it was before the trial. We aren’t going to say the patient can walk, but we can decrease the swelling and inflammation at least.”
Spencer said that company officials hope to achieve better motor function from the patients, and a series of diagnostic tests will be done upon completion of the trial. He added that the trial using this device is taking place in Austria and Germany, and is not sponsored by SoftWave. The trial began in August and is expected to last two years.
“From both an economic and patient care perspective, there is not a more devastating injury that a patient can suffer than a spinal cord injury,” SoftWave CEO John Warlick said. “Based on our preclinical work, and our clinical pilot study, we believe that SoftWave therapy can dramatically reduce the incidence and levels of paralysis in acute spine trauma patients if they can be treated within the first 72 hours post trauma by dramatically reducing the swelling and inflammation to prevent a complete spinal cord injury. I can not imagine a more important clinical study anywhere else in the world than this trial in Austria and Germany at 14 trauma centers.”
Softwave also received Food and Drug administration clearance for the treatment of second degree burns on Aug. 28. Spencer said that Softwave’s device heals second degree burns faster.
“The longer the burn stays open, the more chance it has of getting infected,” Spencer said. “Treatment leads to faster healing times and that is what our treatment will do. We are currently talking to many potential buyers and we are excited to see what happens.”
Aside from the spinal cord trial and second degree burn treatment, SoftWave also has clearance from the FDA for treatment of diabetic foot ulcers, which they received in December of 2019.
SoftWave Tissue Regeneration Technologies develops, manufactures, and sells medical devices used to treat a variety of conditions. These devices are sold directly to orthopedic surgeons, pain physicians, chiropractors, neuro surgeons, and spine surgeons. Spencer said that their devices are also used in sports medicine.