ALPHARETTA, Ga.--SANUWAVE Health, Inc. (OTCBB: SNWV), an emerging medical technology company focused on regenerative medicine, announces that it has raised gross proceeds of $4,102,660 from the exercise of Options that were issued as part of the sale of Units to accredited investors during 2010. The Options had an expiration date of January 31, 2011. In connection with the exercise of Options, the Company issued 2,051,330 shares of Common Stock and 2,051,330 Class D Warrants to purchase one share of Common Stock at an exercise price of $2.00.
“By exercising their Options, current investors have affirmed their confidence in the Company’s direction and commercial potential and provided us with additional capital to advance the U.S. launch of dermaPACE® for the treatment of diabetic foot ulcers”
“By exercising their Options, current investors have affirmed their confidence in the Company’s direction and commercial potential and provided us with additional capital to advance the U.S. launch of dermaPACE ® for the treatment of diabetic foot ulcers,” said Christopher M. Cashman, President and CEO of SANUWAVE.
“SANUWAVE recently reported compelling data from our Phase III clinical trial of dermaPACE ® to treat diabetic foot ulcers, which clearly demonstrated that dermaPACE ® alone significantly accelerated the rate of ulcer closure and significantly reduced ulcer size. This data showed with high statistical significance that at 12 weeks, 48% of patients treated with dermaPACE ® compared to 31% of sham control patients experienced wound closure of 90% or better. Of the patients treated with dermaPACE ® that achieved wound closure at 12 weeks, only 4.5% had recurrence at 6 months. We are very encouraged by these highly positive and clinically meaningful results and look forward to filing the final module of our Premarket Approval (PMA) application with the U.S. Food and Drug Administration (FDA) later this quarter,” added Mr. Cashman.
PACE™, defined as Pulsed Acoustic Cellular Expression, delivers high-energy acoustic pressure waves to produce compressive and tensile stresses on cells and tissue structures to promote angiogenic and positive inflammatory responses, and quickly initiate the healing cascade. This results in revascularization and microcirculatory improvement, including the production of angiogenic growth factors, enhanced new blood vessel formation (angiogenesis) and the subsequent regeneration of tissue such as skin, musculoskeletal and vascular structures. PACE™ treatment triggers the initiation of an accelerated inflammatory response that speeds wounds into proliferation phases of healing and subsequently returns a chronic condition to an acute condition to help re-initiate the body’s own healing response.
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. ( www.sanuwave.com) is an emerging regenerative medicine company focused on the development and commercialization of non-invasive, biological response-activating devices for the repair and regeneration of tissue, musculoskeletal and vascular structures. SANUWAVE’s portfolio of 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. SANUWAVE intends to apply its PACE™ technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE ®, is CE marked for treatment of the skin and subcutaneous soft tissue and recently completed its highly positive pivotal Phase III, Investigational Device Exemption (IDE) trial in the U.S. for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that this technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved Ossatron ® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its Ossatron ®, Evotron™ and orthoPACE™ devices in Europe.
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.