ALPHARETTA, Ga., Feb. 11, 2014 (GLOBE NEWSWIRE) -- SANUWAVE Health, Inc. (OTCBB:SNWV) today announced that it has signed an agreement with Wirthlin, a Dentons Innovation Group Partnership (Wirthlin-Dentons), to provide strategic advisory services and to establish a joint venture company that will license its dermaPACE® device and create a sales and distribution system for the GCC – defined as the Kingdom of Saudi Arabia, United Arab Emirates, Kuwait, Qatar, and Bahrain. The joint venture arrangement expects to have a legal and organizational structure in place in the second quarter of 2014, which enables rollout of SANUWAVE's dermaPACE device in the fourth quarter.
Diabetes – a Significant Problem in the GCC
Diabetes affects between 25% and 35% of the adult population in the GCC. In Saudi Arabia, 24% of the adult population between 20 and 79 years of age are diagnosed diabetes patients. The estimated economic annual cost is over $70 billion with an economic impact of approximately 5.2% of GDP. This physical and financial impact is substantially higher than in the U.S. which has a 9.2% prevalence rate. The International Diabetes Foundation estimates that there will be a 130% increase in the number of people with diabetes in the GCC over the next 20 years.
JV's Approach – Secure Partnerships to Offer a Range of Treatment
The JV brings together Wirthlin-Dentons' international market entry strategy experience and strong relationships within the GCC region, together with its expertise and focus on healthcare and life sciences with SANUWAVE's CE marked dermaPACE to offer non-invasive focused shock wave treatments to repair and rejuvenate diabetic foot ulcers. Over time and in cooperation with each country's Ministry of Health and Diabetes Institute, the JV expects to demonstrate that this chronic condition can be reduced to an acute state. We expect to further demonstrate that by using the dermaPACE device, preventive treatment can be given to reduce the impact of diabetes on the lower extremities.
Treatment for Diabetic Foot Ulcers – Non-invasive and Safe
Current protocols call for up to eight dermaPACE applications: four (4) non-invasive procedures during the first two weeks of treatment, and up to four (4) additional non-invasive procedures delivered bi-weekly thereafter, if necessary. A substantial body of research has demonstrated that the dermaPACE is safe and improves the blood vessel supply to the treated area.
About the dermaPACE Device
The dermaPACE device emits focused, high-energy, acoustic shock waves that restore the body's normal healing processes. Research indicates the technology initiates the reactivation of the body's natural healing cascade, including increased perfusion and blood vessel widening (arteriogenesis), the production of growth factors, formation of new blood vessels (angiogenesis), and the subsequent regeneration of skin tissue, musculoskeletal, and vascular structures. The dermaPACE device is currently being utilized outside the U.S. for the treatment of skin and soft tissue conditions including ulcers, pressure sores, scar reduction, and other types of wound healing. Advanced wound care using the dermaPACE represents a $5 billion U.S. and $22 billion international market opportunity.
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave technology company with approximately 170 devices in use throughout the world. The Company is focused on the development and commercialization of patented non-invasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE's portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body's normal healing processes and leads to regeneration of tissue. In the United States, SANUWAVE intends to apply its patented Pulsed Acoustic Cellular Expression (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 throughout Europe and has device license approval for the treatment of skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA's Premarket Approval (PMA) review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its 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, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE's shock wave technology for non-medical uses, including energy, water, food and industrial markets.
About Wirthlin, a Dentons Innovation Group Partnership
Dentons US LLP (Dentons) and Wirthlin Worldwide International (WWI) joined together to launch Wirthlin, a Dentons Innovation Group Partnership (www.wirthlindentons.com), a new global strategy business consultancy, in May 2013. Wirthlin-Dentons advises clients on global market strategy, international partnerships and venturing and crisis management. This unique partnership joins together Dentons' legal services platform of 80 offices in locations throughout Europe, Africa, the Middle East, Asia, and North America with WWI's seasoned team of business and government leaders with more than 30-years of experience advising global businesses.
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 regulatory approval and 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.
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