ATLANTA, May 19, 2021 (Newswire) – SoftWave Tissue Regeneration Technologies patented extracorporeal shock wave device called the OrthGold 100® was cleared by the FDA on May 4, 2021, for the indications of a temporary increase in local blood circulation, relief of minor aches and pains, and activation of connective tissue. (FDA 510(k) letter-number K210451.)
According to the CDC, an estimated 1 of every 5 adults could be living in chronic pain. 20.4 percent of the U.S. adult population have chronic pain, defined as pain most days or every day for at least the past six months, with a higher prevalence among older people and women. For 8 percent of those with chronic pain (19.6 million adults), daily life or work activities are frequently limited. Arthritis, or joint inflammation, is the most common cause of disability among adults residing in the United States. It limits everyday activities for 24 million Americans. 80 percent of Americans experience lower back pain in their lifetime with an estimated cost of $50 billion annually.
SoftWave’s technology gives physicians and other healthcare professionals another treatment option when addressing muscle and joint pain. The OrthoGold 100® can provide relief from tendonitis, bursitis, arthritis, and other common conditions. “This revolutionizes the way pain is treated in a therapeutic setting,” says John Warlick, CEO of SoftWave TRT. “With a company focus on innovation, adding more patents, and contributing to our pipeline of future clearances and approvals, we believe SoftWave TRT is positioned to offer the best shock wave technology and be the leader in this growing segment of medical technology.”
SoftWave TRT currently has FDA clearance for the treatment of superficial, partial-thickness, second-degree burns in adults, and the treatment of Diabetic Foot Ulcers (DFU’s).
SoftWave TRT’s patented technology uses an unfocused extracorporeal shock wave (uESWT) to promote both a physical and biological response in order to improve healing. It positively influences the activity of immune cells, has an anti-inflammatory potential, including the stimulation of mesenchymal stem cells and the release of factors relevant to regeneration and healing. In addition, the shock wave intervenes directly in the signal transmission of pain and has both short-term and long-term analgesic effects. One of the advantages of SoftWave Therapy is relieving acute pain in the short term and providing long-term relief by dissolving the actual cause through regeneration and healing. It is a non-invasive procedure and requires no anesthesia or numbing agents so it’s well-tolerated by patients.
About SoftWave Tissue Regeneration Technologies
SoftWave Tissue Regeneration Technologies, LLC is a medical technology company developing advanced solutions for better patient healing specializing in shock wave therapy. Headquartered in Woodstock, GA, SWTRT technology is used worldwide in the healthcare fields of orthopedics, traumatology, wound care, aesthetics and urology.
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