On December 28, 2017, SANUWAVE Health, Inc., a Nevada Corporation (the “Company”), received notice from the United States Food and Drug Administration permitting marketing of the dermaPACE® System. The letter from the FDA is furnished on this Current Report on Form 8-K (this “Current Report”) as Exhibit 99.1 and incorporated by reference herein.

The Company also issued on December 29, 2017, a press release regarding the FDA’s notice and a conference call to be held by the Company on January 2, 2018, at 11:00 am eastern to discuss the FDA letter and its implications for the Company. The press release is furnished on this Current Report as Exhibit 99.2 and incorporated by reference herein.

(d) Exhibits.

SANUWAVE Health, Inc. Exhibit
EX-99.1 2 snwv_ex991.htm LETTER FROM THE U….
To view the full exhibit click here

About SANUWAVE HEALTH, INC. (OTCMKTS:SNWV)

SANUWAVE Health, Inc. is an acoustic pressure shock wave technology company using a system of noninvasive, high-energy, acoustic pressure shock waves for indications, such as regenerative medicine and other applications. The Company is focused on 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. Its lead regenerative product in the United States is the dermaPACE device, used for treating diabetic foot ulcers. Its portfolio of healthcare products and product candidates activate biologic signaling and angiogenic responses, including new vascularization and microcirculatory improvement, enabling to restore the body’s normal healing processes and regeneration. It is focused on developing its Pulsed Acoustic Cellular Expression (PACE) technology to activate healing in wound conditions.