ALPHARETTA, Ga., Sept. 10, 2013 (GLOBE NEWSWIRE) -- SANUWAVE Health, Inc. (OTCBB:SNWV) today reported that its orthoPACE® device has received official regulatory approval from the South Korean Ministry of Food and Drug Safety (MFDS – South Korea). With this approval, SANUWAVE will begin commercializing orthoPACE in South Korea. The orthoPACE device has been proven safe and effective for the treatment of chronic tendonitis and joint pain in the musculoskeletal system. orthoPACE treatments have been especially effective in treating plantar fasciitis and tendonitis, which commonly require surgery.
"I'm extremely excited by this news," commented Mr. Byung Ho Lee, Chief Executive Officer of KOVE Ltd. Co, the Company's exclusive distributor for South Korea. "The orthoPACE device, with its patented focused shock wave technology, is an important advancement in orthopedic and musculoskeletal care and offers a wide range of non-invasive treatment procedures for hospitals and doctor's offices. I'm certain it will be welcomed by Korean orthopedists and their patients."
"The pain market in Korea has increased dramatically in recent years as the population ages, and this trend is true for Japan and other Asian countries as well," commented Joseph Chiarelli, Chief Executive Officer of SANUWAVE. "The MFDS – South Korea regulatory approval brings this breakthrough medical device to the forefront of the Asian market by offering a new solution for patients suffering from bone and chronic tendonitis. We see a huge potential in the Asian market for this unmet need."
orthoPACE is designed to effectively treat bone conditions requiring osteogenesis, calcific joints, conditions causing painful joints, and chronic pain caused by musculoskeletal disorders. orthoPACE uses focused shock wave treatments that are non-invasive which dramatically reduces the risk of infection. In many indications, orthoPACE has a proven success rate that is equal to or greater than that of surgery – usually with just one procedure and without the inherent risks, complications and lengthy recovery time of invasive surgery. orthoPACE treatments require a minimal amount of treatment time. In conditions such as plantar fasciitis, patients can bear weight immediately and return to pre-treatment activity within a few days of the procedure.
Mr. Chiarelli concluded, "The approval of our orthoPACE device by MFDS – South Korea is another step forward in introducing our innovative technology in major markets worldwide. It also confirms our capacity to navigate approval processes in various countries to further maintain our leading position in focused shock wave therapy markets. Our patented shock wave technology has proved successful and demonstrated high efficiency rates, thus bringing significant benefits to patients and users."
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave technology company initially 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 regeneration. SANUWAVE intends to apply its patented 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 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 for non-medical uses, including energy, water, food and industrial markets.
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.