SUWANEE, GA, Aug. 14, 2019 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — SANUWAVE Health, Inc. (OTCQB: SNWV) an
emerging medical technology company focused on the development and
commercialization of noninvasive, biological response activating devices
in regenerative medicine, today announces that due to changes in
reimbursement coverage in certain markets, the company is accelerating
its entry in those markets one year ahead of its strategic plan. This
expansion brings the total number of states SANUWAVE is currently
targeting to 15.
Kevin Richardson, CEO of SANUWAVE, commented, “The dermaPACE® System is the only FDA cleared shockwave (ESWT) medical system for treating Diabetic Foot Ulcers (DFU’s). This places SANUWAVE in a unique situation to help deliver positive results and evidence in managing and treating real-life DFU’s. SANUWAVE has been aggressively working on gaining traction among the payor community through outreach, education, and claims submissions. Recently, SANUWAVE learned that National Government Services (NGS) Medicare Administrative Contractor has issued updated coverage guidance for CPT codes 0512T and 0513T (Extracorporeal shockwave therapy for integumentary wound healing, high energy), effective July 1, 2019 in the Local Coverage Article (LCA) A56195 titled “Billing and Coding: Category III CPT® Codes”. Both CPT codes have been removed from the Group 1 Codes category (always considered not medically necessary) and are now included within the Group 3 Codes category (individually reviewed to determine medical necessity). National Government Services (NGS) administers benefits to 7 million A/B Medicare members in 10 states (NY, ME, RI, VT, CT, NH, MA, MN, WI, and IL). This change in coverage is viewed as extremely positive for SANUWAVE and comes a full year ahead of when SANUWAVE had expected this to occur.”
These 10 states represent 47.5 million people with 5.8 million suffering from diabetes, according to the American Diabetes Association (ADA). It is estimated that 15% of a diabetic population will suffer from a DFU in any given year of which 70% will reach a stage that is considered advanced. The dermaPACE System targets DFU’s in the advanced stage (defined as at least 4 weeks old with less than 50% wound area reduction from treatment using standard of care). Over 600,000 patients would fit the treatment profile for dermaPACE® in this 10 state region, in any given year, representing a total market revenue opportunity for SANUWAVE of over $1 billion (based on current protocol and pricing). As a result of these developments, SANUWAVE plans to hire additional sales professionals and clinical account managers in these new regions to continue our growth as we anticipate a large percentage of our placements, going forward, coming from the NGS region.
“We have already shifted gears and accelerated both placing dermaPACE Systems and performing procedures in these new territories. We are seeing strong product acceptance, which is largely based on the strong results presented in the 336 patient clinical trial that we performed for FDA submission. The FDA clearance included sections highlighting not just our efficacy but also the safety of the dermaPACE System and a detailed section containing our scientific special controls documentation. The special controls show the differentiation of SANUWAVE systems energy output, or treatment parameters, when compared with other products that utilize different types of shockwave generators or acoustic pressure wave (non-shockwave) generators for the medical field. In speaking with many of the billing departments in the region, all have mentioned the FDA clearance as a key factor in feeling comfortable in utilizing the dermaPACE System medically and billing for it ethically,” concluded Mr. Richardson.
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (OTCQB:SNWV) (www.SANUWAVE.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, 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 applies 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 US FDA cleared for the treatment of Diabetic Foot Ulcers. The device is also CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, South Korea, Australia and New Zealand. 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.
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.
For additional information about the Company, visit www.sanuwave.com.
Millennium Park Capital LLC
SANUWAVE Health, Inc.
Kevin Richardson II
CEO and Chairman of the Board