SUWANEE, GA, May 14, 2020 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce they will be offering dermaPACE® System solutions to treat patients in a home setting.
SANUWAVE Health has quickly adapted to the changes occurring in the world of wound care. The COVID-19 pandemic impacting the globe has changed, in the near term, and potentially the long term, the way wounds are being treated. The experts are calling this paradigm shift “Wound Care Without Walls.” The patients that would normally be treated on a weekly, or more often, basis in a wound clinic setting are now in need of evaluation and treatment in their home setting. Center for Medicare and Medicaid Services (CMS) has moved quickly to allow reimbursement through use of certain waivers, allowing clinicians and home care organizations to treat these patients in their home. A lot of press has covered the telemedicine initiatives doctors are using to evaluate and triage patients during the crisis. Wound care, unfortunately, is not something that can be considered elective. Wounds must be treated on a regular basis, otherwise infections will set in and the likelihood of amputations could increase dramatically. A webinar survey conducted recently indicated 40% of clinicians are seeing an increase in amputation likelihood due to patients foregoing treatments by avoiding the clinic setting. Clearly, a need for treatment in the home setting exists and now with reimbursement criteria clear SANUWAVE will launch dermaPACE® Mobile System.
The mobile unit will initially roll out in ten clinics that have expressed urgency in bringing the product to market. Each clinic will have either a doctor, physician assistant (PA), or registered nurse deliver the dermaPACE® Mobile System treatment in the home along with other wound treatment modalities like debridement and dressing changes. “We listened to the market’s needs and consulted our key advisors about the best approach to bring dermaPACE® into the home. We are glad the waivers exist in this crisis to treat these patients that would otherwise not be treated and would potentially develop an infection. Infections lead to amputations and the statistics about diabetic foot ulcer (DFU) amputation survival rates are dismal; less than 30% will live more than 5 years after an amputation. We are glad we can treat patients and offer our clinics a way to reach the patients and continue their needed treatments in a home environment. Clinics cannot take a Hyberbaric Chamber into a patient’s home, but they can take dermaPACE® Mobile System to treat them,” said Kevin Richardson, CEO of SANUWAVE Health, Inc.
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (OTCQB: SNWV) is a shockwave 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 shockwave 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