SoftWave Tissue Regeneration Technologies Receives FDA Clearance for the Treatment of Burn Wounds – PRNewswire

ATLANTA, Sept. 1, 2020 /PRNewswire/ --SoftWave Tissue Regeneration Technologies, a disruptive bio-medical device company, was cleared by the FDA on Friday, Aug. 28, 2020, for the treatment of superficial, partial-thickness, second-degree burns in adults (FDA 510k letter number K200926). SoftWave also has clearance for the treatment of Diabetic Foot Ulcers (DFU's), making it the only ESWT company to have two clearances for both acute (burns) and chronic wounds (DFU's). SoftWave therapy gives physicians, who treat burn patients, another option in healing burn wounds.

Each year, in the United States, approximately 450,000 patients receive medical attention, at emergency rooms, for burn related injuries. Most superficial wounds heal in two weeks; however, patients who suffer severe burns must endure intense physical and psychological pain during the burn injury treatment phase. There are over 3,400 burn injury deaths, including 1,100 children every year. The CDC estimates that $7.5 billion dollars are spent each year for burn related injuries. After the treatment phase is over and wounds are healed, scarring and disfigurement may interfere with movement, mobility, and daily life functions, resulting in a lifetime of physical and emotional burdens.

SoftWave's technology uses an unfocused extracorporeal shock wave (uESWT) to promote both a physical and biological response in order to improve wound healing. In a prospective randomized trial conducted by Dr. Christian Ottomann, published in the Annals of Surgery, significant accelerated epithelialization was demonstrated in the patients who had undergone uESWT (9.6 1.7 days) as compared to the patients who did not undergo uESWT (12.5 2.2 days); a statistically significant reduction in the days required for healing (3). This change is a substantial factor for any burn patient. The SoftWave biological response for wound healing is associated with neovascularization, and an increase in oxygenation and perfusion, ultimately resulting in angiogenesis. The hypothesized mechanisms of action for accelerated wound healing include stem cell activation and recruitment, and a reduction in the inflammation as proven in our published TLR3 model.

About SoftWave Tissue Regeneration Technologies

SoftWave TRT is a bio-medical device company that has proprietary patented technology, using unfocused acoustic waves, to treat a variety of conditions. The OrthoGold was first cleared in 2018 for the activation of connective tissue and registered for pain reduction and increased blood flow. Our second clearance, in 2019, was for the treatment of Diabetic Foot Ulcers. SoftWave TRT has over thirty patents for a variety of indications, including the following: stem cell activation, cellulite reduction, numerous indications involving the heart, and wound healing. SoftWave TRT plans to pursue FDA clearance, for all ESWT therapies, targeted by other publicly traded shockwave companies including Sanuwave (SNWV), Soliton (SOLY) and Shockwave Medical (SWAV). SoftWave believes our patented "softwaves" have superior benefits compared to traditional ESWT, and we are conducting multiple clinical trials to demonstrate the effectiveness over current available therapies.

Twitter: @SoftwaveTRT

Source: SoftWave Tissue Regeneration Technologies

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SoftWave Tissue Regeneration Technologies Receives FDA Clearance for the Treatment of Burn Wounds – PRNewswire