ALPHARETTA, Ga., March 26, 2013 (GLOBE NEWSWIRE) -- SANUWAVE Health, Inc. (OTCBB:SNWV) announced today the launch of its dermaPACE® wound healing system in Australia and New Zealand. dermaPACE received the Australian Therapeutic Goods Administration (TGA) approval in March 2013 to be used for healing acute and chronic wounds.
In addition, SANUWAVE has entered into an exclusive distribution agreement with Aurora BioScience Pty. Ltd. to distribute the dermaPACE device throughout Australia and New Zealand. Established nearly 10 years ago, Aurora BioScience strives to put in place proven, cost-effective solutions that help Australians and New Zealanders live longer and healthier lives, through a diverse range of medical offerings. Aurora BioScience is the exclusive distribution partner in Australia for seventeen of the world's leading medical device manufacturers. Their customers include the various Departments of Health, the Australian Red Cross Blood Service and most public and private hospitals across the region. The addition of dermaPACE enhances Aurora BioScience's goal of providing new and innovative technologies in the area of wound care management to the Australian and New Zealand medical device markets.
Chronic wounds annually affect more than 500,000 Australians with an annual cost which exceeded $A3 billion in 2005 according to the Australia Wound Management Association and the Australia Medical Association.
"We are very excited to have received regulatory approval for our dermaPACE device in Australia and New Zealand to treat a wide range of acute and chronic wounds," stated Joseph Chiarelli, Chief Executive Officer of SANUWAVE. "Aurora BioScience is a welcome addition to the growing distribution network for our PACE technology. Their focus on the treatment of debilitating and costly ulcers leverages the positive data from our pivotal clinical trial using dermaPACE."
"The dermaPACE is an exciting new development for the treatment of wounds, especially chronic, difficult to treat wounds," said Darren Banks, Managing Director of Aurora BioScience. "We believe in the potential for the dermaPACE to positively impact patients whose lives suffer from debilitating wounds and injuries. We believe the dermaPACE device can provide improved patient outcomes at reduced costs. We are expecting the first procedures to be undertaken in Australia in late March with many hospitals and clinics extremely excited to evaluate the product."
Mr. Chiarelli concluded, "This collaboration is exciting news for both organizations, and we are equally committed to reach the ultimate goal of establishing dermaPACE as a first-line wound healing technology throughout Australia and New Zealand."
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of noninvasive, biological response activating devices for the repair and regeneration of tissue, musculoskeletal and vascular structures. SANUWAVE's portfolio of regenerative medicine 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 and has device license approval for the treatment of the 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 and Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE's shock wave technology in non-medical uses, including energy, water, food and industrial markets.
About Aurora BioScience Pty. Ltd.
Based in Sydney, Australia, Aurora BioScience is committed to providing advanced, high quality medical devices and healthcare products to assist medical professionals within Australia, New Zealand and the Pacific Islands healthcare markets, which contribute to the enhancement of patient's quality of life, in areas including wound healing, cancer therapies, neurology, pulmonology, hematology and blood products. For more information, please visit www.aurorabioscience.com.au
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.
Source:SANUWAVE Health, Inc.