BioElectronics has secured approval from the US Food and Drug Administration (FDA) for its RecoveryRx medical device to treat postoperative pain.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
RecoveryRx will help reduce postoperative pain and exposure to long-term effects of opioid/NSAID therapy, said the company in a statement.
According to the company, less than 50% of patients who undergo surgery report adequate postoperative pain relief.
The approval allows RecoveryRx drug-free therapy to the 15 million Americans who experience postoperative pain from 25 million surgeries per annum.
In addition, RecoveryRx therapy is having a significant market opportunity among the 7 million chronic wound patients with debridement and negative vac therapy treatments.
RecoveryRx uses pulsed electromagnetic therapy to decrease pain and inflammation, helping to accelerate patient recovery and improved comfort.
BioElectronics noted that RecoveryRx has been clinically demonstrated to significantly reduce postoperative pain and the use of narcotic pain medication postoperatively.
The device significantly reduces the required level of pain medications in postoperative surgical recovery, helping to decrease narcotic medication use and side effects and potentially limit the incidence of chronic pain.
BioElectronics president Andrew Whelan said: “We are delighted that the FDA has recognized the potential of RecoveryRx in transforming postoperative pain care.
“RecoveryRx, with its high degree of safety, excellent clinical evidence of effectiveness and exceptional cost-benefit, will become the standard of care.”
The firm is also engaged in the preparation of documentation for its ActiPatch 510(k) to receive expanded approval to treat general musculoskeletal pain. BioElectronics plans to file the application within the next few weeks.
ActiPatch therapy is the over-the-counter treatment for back pain and other musculoskeletal complaints, while RecoveryRx devices are used for chronic and post-operative wound care. It also produces Allay menstrual pain therapy.
ActiPatch offers advanced long-lasting chronic pain relief using electromagnetic pulse therapy and works better for back pain, knee pain, muscle and joint pain, arthritis, sciatica, fibromyalgia, strains and sprains.
BioElectronics, which is a major produce of non-invasive electroceuticals, is involved in the making of disposable, drug-free and pain therapy devices.