SUWANEE, GA, March 02, 2018 (GLOBE NEWSWIRE) -- SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the first product shipments in the U.S. market of the company’s dermaPACE®System occurred this week. Since receiving FDA clearance for the dermaPACE System for the treatment of Diabetic Foot Ulcers (DFU) on December 28, 2017, the response has been overwhelmingly positive. In this short time period, we have developed a strong backlog of product demand. By having financing from NFS in place, along with our partnership with Premier Shockwave, we have begun shipments. In parallel, we continue to support our international partners while pursuing additional, international markets. The interest from wound care specialists in the U.S. has been greater than our expectations, and we have seen an uptick in interest from international markets since the FDA clearance announcement. SANUWAVE’s Chairman of the Board and CEO, Kevin A. Richardson II said, “We are ecstatic to have the first few dermaPACE Systems out the door for the U.S. market and generating revenue. More importantly, we see dermaPACE as a game-changer for the wound care market, potentially revolutionizing the approach to treating chronic wounds.”
The dermaPACE System offers a novel treatment modality for DFUs, delivering shock wave energy in a non-invasive manner. Treatment consists of 4 - 8 short, non-invasive applications over a 2 to 10-week period. Monitoring and standard of care is required thereafter. This non-invasive treatment provides lower patient adverse events compared with other modalities and as a result, the dermaPACE System provides a safe and effective option for treating patients with diabetic foot ulcers.
Due to its non-invasive nature, the dermaPACE System does not prevent the use of other treatment options (i.e., dermal grafts, wound matrices, biologic gels, and surgery) in conjunction with the dermaPACE System or in later stages of wound care. In fact, wound care professionals using the device in Europe, Canada, and Australia use the dermaPACE System in the progression of their treatment regimen for wound management with healing as the final intent. Not all wounds, nor all patients are the same, therefore, each wound is treated on an individual basis based on the treating physician’s knowledge and the treatment options available. Continues Mr. Richardson, “The dermaPACE system offers the ability to manage the DFUs chronicity and is a powerful tool in the clinician’s arsenal to achieve wound closure.”
In addition to causing suffering and morbidity, foot lesions in diabetic patients have substantial economic consequences. Diabetic foot complications result in huge costs for both society and the individual patients. The economic burden of DFUs and the complications arising from them are enormous. The cost to treat a DFU over a 2-year period was $27,987 in 1995 and, based on the medical component of the US Consumer Price Index, rose to $46,841 in 2009. These high costs have been linked to frequent outpatient appointments, in-patient days, laboratory tests, drugs/medications, hospital stays, and secondary complications of osteomyelitis and amputation. Direct costs for a lower-extremity amputation range from $22,700 to $51,300.
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.
Forward-Looking Statements
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.