SANUWAVE Health Receives Approval from The National Health Surveillance Agency (ANVISA) to Market dermaPACE to Treat Chronic Wounds in Brazil

Plans for Immediate Commercial Launch via Established Joint Venture

Suwanee, GA - (NewMediaWire) - August 24, 2020 - SANUWAVE Health, Inc. (OTCQB: SNWV), focused on the development and commercialization of patented PACE® technology platform for the repair and regeneration of skin, musculoskeletal tissue and vascular structures, announced today that the Company has received approval from the Brazilian Agência Nacional de Vigilância Sanitária (“National Health Surveillance Agency” or “ANVISA”) to market its proprietary dermaPACE® System to treat diabetic foot ulcers (DFUs) in Brazil.

In November 2019, SANUWAVE Health entered into a joint venture agreement with the IDIC Group of Sao Paulo, Brazil for the exclusive rights to market dermaPACE as a treatment for chronic wounds in South America in exchange for joint profit sharing.  The joint venture operates as Diversa, SA and will be responsible for marketing the dermaPACE in Brazil.  SANUWAVE Health will receive the remaining US$100,000 of the partnership fee upon ANVISA approval of dermaPACE and the Company expects to record this as revenue in the third quarter of 2020.  

“Receipt of ANVISA approval to market dermaPACE in Brazil is a key milestone of our international strategy to bring our shockwave technology to benefit the millions of patients throughout South America suffering with chronic wounds,” said Kevin A. Richardson, II, Chairman and Chief Executive Officer of SANUWAVE Health, Inc.  “As the largest country in South America, we are particularly pleased to launch our dermaPACE initiatives in wound care in Brazil with our partner, Diversa.  Importantly, the team at Diversa shares our passion and commitment to bring our non-invasive, innovative technologies to patients in order to initiate the healing cascade, accelerate wound healing and provide a novel therapeutic modality for these difficult to treat chronic wounds.”

Diversa expects to place ten dermaPACE systems in Brazil by the end of 2020, with a plan to initially deploy the systems in the private pay arena, which represents 45 million people.  Diversa will conduct pharmacoeconomic studies to demonstrate both the clinical efficacy of the dermaPACE system to treat DFUs and to establish the economic value provided by reduced rehospitalizations and limb amputations, both of which carry a substantial economic burden to Brazil’s government healthcare system.  Diversa anticipates that each system will generate approximately US$150,000 per year initially.  

“With the ANVISA approval, we are ready to begin deploying dermaPACE Systems and their ancillary products to hospitals and wound care centers throughout Brazil,” stated Daniel Feliciano Ferreira, Chief Executive Officer of Diversa, SA. “The dermaPACE System is an ideal product for achieving our goal to bring new and innovative technologies to benefit patients, while also providing economic benefit to the healthcare system.  We look forward to a successful product launch in Brazil and expect that the superior clinical outcomes will also demonstrate the pharmacoeconomic benefits of the dermaPACE in treating chronic DFUs.  Moving forward, we plan to expand the use of the dermaPACE system to other chronic wound settings such as venous leg ulcers and pressure wounds.  Toward that end, we expect to initiate a clinical study of the dermaPACE system in venous ulcers in the coming months.”  

About Diabetic Foot Ulcers in Brazil

According to International Diabetes Federation data, Brazil has 12.5 million adults diagnosed with diabetes.  This represents the fourth largest in country population in the world and approximately 9% of the adult population.  Reliable local studies indicate that 7% of diabetic adults develop DFUs, so the current DFU patient population in Brazil stands at approximately 900,000.  Currently, there are no effective curative treatments for DFUs being utilized in Brazil, which has led to high rates of lower limb amputations. 

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (OTCQB:SNWV) (www.SANUWAVE.com) 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 Brazil, 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. 

For additional information about the Company, visit www.sanuwave.com.

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.

Contact:

SANUWAVE Health, Inc.
Kevin Richardson II
Chairman and Chief Executive Officer
978-922-2447
investorrelations@sanuwave.com

Anne Marie Fields

Managing Director

Rx Communications Group 

afields@rxir.com