SoftWave Tissue Regeneration Technologies09.02.20
On August 28, SoftWave Tissue Regeneration Technologies, a disruptive bio-medical device company, was cleared by the FDA for the treatment of superficial, partial-thickness, second-degree burns in adults. 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.
How It Works
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 the company's published TLR3 model.
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.
How It Works
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 the company's published TLR3 model.
