Shock wave technology company SANUWAVE Health, Inc. announced it has enrolled its first patient in the supplemental Phase III clinical trial of dermaPACE, a device for treating diabetic foot ulcers, and that patient has begun treatment. The clinical trial has been designed to enroll a minimum of 90 patients at up to 20 sites in the United States.
"Enrolling and treating the first patient is an important milestone in our efforts to bring the CE Marked dermaPACE device to the U.S. market," said SANUWAVE CEO Joseph Chiarelli.
The company plans to demonstrate, through a successful trial, that the dermaPACE device can provide significant benefits over currently used therapies for diabetic foot ulcers. The dermaPACE is a simple, comfortable and unobtrusive treatment option that emits focused, high-energy acoustic shock waves that restore the normal healing processes of the body.
As a result of SANUWAVE's recent investigator meeting, many of the 20 clinical sites for the dermaPACE clinical trial have patients currently undergoing the initial screening process for enrollment.
As diabetic foot ulcers are a common and debilitating problem among diabetes patients, SANUWAVE hopes to bring to market a cost-effective method for promoting the natural healing process for patients with chronic, non-healing ulcers.
SANUWAVE is a shock wave technology company that is initially focused on developing and commercializing noninvasive, biological response activating devices for repairing and regenerating tissue, musculoskeletal and vascular structures. The company has a portfolio of regenerative medicine products and product candidates that activate biologic signaling and angiogenic responses, resulting in new vascularization and microcirculatory improvement that helps restore the body's normal healing processes and regeneration. The company plans to apply its patented PACE technology for wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. dermaPACE is SANUWAVE's lead product candidate for the worldwide wound care market, and the device is CE Marked throughout Europe and has device license approval in Canada, Australia and New Zealand for treating the skin and subcutaneous soft tissue.
In addition to medical uses, there are also license/partnership opportunities available for nonmedical uses of SANUWAVE's shock wave technology, including energy, water, food and industrial markets.
For more information, visit the company's Web site at sanuwave.com
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