ALPHARETTA, Ga.--(BUSINESS WIRE)-- SANUWAVE Health, Inc. (OTCBB:SNWV.ob - News), an emerging medical technology company focused on the development and commercialization of noninvasive, biological response activating devices in regenerative medicine, today announced that the American Medical Association (AMA) has released two Current Procedural Terminology (CPT) Category III codes for Extracorporeal Shock Wave Technology (ESWT) in wound healing: 0299T and 0300T.
Pending approval by the U.S. Food and Drug Administration (FDA) of the Company’s Premarket Approval (PMA) application, SANUWAVE’s dermaPACE would be the first and only ESWT device in the U.S. capable of utilizing these codes.
CPT Category III codes are a set of tracking codes established by the AMA that permit data collection for emerging technology, services and procedures such as dermaPACE, which has been submitted to the FDA as a treatment for diabetic foot ulcers (DFU). The new codes were released on July 1, 2011 and will be implemented on January 1, 2012.
"We are pleased that the AMA has endorsed tracking utilization of ESWT in wound healing. Their decision was based on the highly compelling and growing body of peer-reviewed published clinical data, the enthusiastic support from multiple medical societies and their own internal due diligence," said Christopher M. Cashman, President and Chief Executive Officer of SANUWAVE.
“The release of these CPT Category III codes represents another major milestone in the commercialization strategy for dermaPACE. We can now educate payers on the clinical and economic benefits of dermaPACE for treating diabetic foot ulcers. After FDA approval of dermaPACE, we will work to secure utilization and positive coverage policies to allow for physician payment of dermaPACE procedures, ultimately resulting in permanent CPT codes,” added Mr. Cashman.
PACE, defined as Pulsed Acoustic Cellular Expression, delivers high-energy acoustic pressure waves in the shock wave spectrum 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 reinitiate 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 noninvasive, 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) clinical 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.
SANUWAVE Health, Inc.Barry Jenkins, 678-578-0103CFOorBernie Laurel, 678-578-0103VP of Sales and Marketinginvestorrelations@sanuwave.comorLippert/Heilshorn & AssociatesAnne Marie Fields (Investors), firstname.lastname@example.orgMegan Rusnack (Media), email@example.com