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PACE Technology Our product candidates, including our lead product candidate dermaPACETM, utilize high energy, acoustic pressure waves that are delivered in the "shock wave" acoustic spectrum. Shock waves used in PACETM technology are different from other forms of acoustic energy, such as ultrasound, in that the wave front, in which the compressive forces exist, is a region of sudden and forceful change in stress, density, and temperature. Shock waves are characterized by - High pressure amplitudes, with rapid rise times, a short life cycle, and a frequency spectrum ranging from the audible to the ultrasonic region. Illustration of Pressure Wave Production from the PACE Applicator Pressure Wave Generation To produce high energy pressure waves, PACE applicators are equipped with an electrode encapsulated in a fluid medium of proprietary components and materials. A specially curved reflector, located at the base of the housing behind the electrode, reflects the energy produced when the electrode activates sending a focused pressure wave to a culminating point called the focal point. The focal point is focused onto the targeted treatment areas of the body. The characteristics and specification of this technology and methodology that optimize the treatment effects are proprietary in nature. Mechanism of Action PACE pressure waves combine compressive and tensile stresses on cells and structures to promote an inflammatory response in musculoskeletal and soft tissue resulting in revascularization and microcirculatory improvement, including the production of angiogenic growth factors, enhanced new blood vessel formation "angiogenesis", and the subsequent regeneration of tissue. PACE waves help with re-initiating the inflammatory and proliferation phases and subsequently return a chronic condition to an acute condition and help the body’s own healing response to re-initiate. We believe that these mechanisms make PACE well suited for various applications due to its stimulation of a broad spectrum of cellular events critical for the initiation and progression of healing. Educational Materials   Experimental Review of the Mechanisms of Action for Pulsed Acoustic Cellular Expression (PACE™) Technology   Pulsed Acoustic Cellular Expression (PACE™) Technology Supports Chronic Wound Healing   Quick Healing of Foot Ulceration Wound Using dermaPACE™Technology and Rehabilitation   Comparison of Pulsed Acoustic Cellular Expression (PACE™) Technology versus Hyperbaric Oxygen Therapy (HBO)   European Experience with Pulsed Acoustic Cellular Expression (PACE™) Technology in the Treatment of Diabetic Foot Ulcers Scientific literature is being provided for educational purposes only. Not all indications are FDA approved. SANUWAVE does not claim safety or efficacy for unapproved products and treatment indications. The dermaPACE device is currently the subject of an Investigational Device Exemption (IDE) study and is not available or for sale in the United States.