Note 1 - Nature of the Business

9 Months Ended

Sep. 30, 2016

Notes to Financial Statements

Nature of Operations [Text Block]

1.            

Nature of the Business

SANUWAVE Health, Inc. and subsidiaries (the “Company”) is an acoustic pressure shock wave technology company using a patented system of noninvasive, high-energy, acoustic pressure shock waves for indications such as regenerative medicine and other applications. The Company’s initial focus is regenerative medicine – utilizing noninvasive (extracorporeal), acoustic pressure shock waves to produce a biological response resulting in the body healing itself through the repair and regeneration of skin, musculoskeletal tissue and vascular structures. The Company’s lead regenerative product in the United States is the dermaPACE

®

device, used for treating diabetic foot ulcers, which was subject to two double-blinded, randomized Phase III clinical studies. A

de novo

petition was sent to FDA on July 23, 2016 requesting Agency review and classification of the dermaPACE device for treating diabetic foot ulcers as a Class II device, for possible approval in late 2016 or early 2017.

The Company’s portfolio of healthcare products and product candidates activate biologic signaling and angiogenic responses, including new vascularization and microcirculatory improvement, helping to restore the body’s normal healing processes and regeneration. The Company intends to apply its Pulsed Acoustic Cellular Expression (PACE

®

) technology in wound healing, orthopedic, plastic/cosmetic and cardiac/endovascular conditions. Revenues are from sales of the European Conformity Marking (“CE Mark”) devices and accessories in Europe, Canada, Asia and Asia/Pacific.

In addition to healthcare uses, our high-energy, acoustic pressure shock waves, due to their powerful pressure gradients and localized cavitational effects, may have applications in secondary and tertiary oil exploitation, for cleaning industrial waters, for sterilizing food liquids and finally for maintenance of industrial installations by disrupting biofilms formation. Our business approach will be through licensing and/or partnership opportunities.