Sanuwave Health, Inc. Receives FDA De Novo Decision to Immediately Market the Dermapace System for the Treatment of Diabetic Foot Ulcers in the U.S
January 02, 2018 at 08:00 am
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SANUWAVE Health, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued its decision on the de novo submission for the dermaPACE® System. Their decision, dated December 28, 2017, permits the marketing of the dermaPACE System as a Class II medical device used for the treatment of Diabetic Foot Ulcers (DFU) in the U.S., the world’s largest medical device market. This order by FDA is the culmination of intensive clinical studies by the company and diligent work by both the company employees and regulatory partners, Musculoskeletal Clinical Regulatory Advisers (MCRA) in successfully submitting documentation and interacting with FDA during the clearance process. The dermaPACE System offers a novel treatment modality for DFUs, delivering shock wave energy in a non-invasive manner. Treatment consists of 4 - 8 short, non-invasive applications over a 2 to 10 week period. Monitoring and standard of care is required thereafter. This non-invasive treatment provides lower patient adverse events compared with other procedures like amputation or skin grafting, and as a result, the dermaPACE System provides a safe and effective option for treating patients with diabetic foot ulcers.
Sanuwave Health, Inc. is an ultrasound and shock wave technology company. The Company is a provider of Food and Drug Administration (FDA)-approved wound care products. It is focused on the research, development, and commercialization of its patented, non-invasive and biological response-activating medical systems for the repair and regeneration of skin, musculoskeletal tissue, and vascular structures. The Company applies and researches its patented energy transfer technologies in wound healing, orthopedic/spine, aesthetic/cosmetic, and others. Its two primary systems are UltraMIST and PACE. The UltraMIST system provides, through a fluid mist, low-frequency, non-contact, and pain free ultrasound energy deep inside the wound bed that promotes healing from within. The PACE systems use acoustic pressure shockwaves generated by the Company's Pulsed Acoustic Cellular Expression (PACE) technology to converge at precise selected targets to produce an extremely short duration compression burst.