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SANUWAVE Successfully Completes Extensive Round of Quality System and Technical File Audits

October 30, 2019 GMT

Suwanee, GA - ( NewMediaWire ) - October 30, 2019 - SANUWAVE Health, Inc. (OTCQB: SNWV) is a shockwave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating shockwave systems for the repair and regeneration of skin, musculoskeletal tissue and vascular structures.  SANUWAVE’s key to success is its pursuit of Quality. The company is very pleased to announce that an extensive round of Quality System audits by multi-national organizations have been successfully completed.  These audits and system evaluations were conducted against numerous international standards and regulations including: ISO 13486:2016, US 21 CFR Part 820, EU Medical Device Regulations, Medical Device Single Audit Program (encompassing the national medical regulatory requirements of the U.S., Canada, Australia, Brazil, and Japan), and South Korea Medical Device Regulations.

These audits began in the early spring of 2019 with SANUWAVE successfully passing the audit for the transition to ISO 13485:2016, the international quality system standard particularly established for medical devices.  This internationally recognized standard sets the requirements and expectations for all medical device manufacturers in designing, implementing, and maintaining their business and quality systems.  

Following in rapid succession, SANUWAVE’s product technical files were successfully audited for compliance with the European Union’s Medical Device Directive, the set of legal requirements all products distributed in the EU must comply to. 

In late August, SANUWAVE’s Quality System was audited under the Medical Device Single Audit Program (MDSAP).  The MDSAP is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions of the U.S., Canada, Australia, Brazil, and Japan. This comprehensive, five-day audit was successfully completed and now SANUWAVE is MDSAP compliant.  

Shortly thereafter, the Korean Ministry of Food and Drug Safety (MFDS, Korea’s counterpart to the U.S. FDA) successfully conducted a 4-day audit of SANUWAVE’s Quality System.  

SANUWAVE is pleased to report that these four audits found SANUWAVE’s products and systems in compliance with all regulatory standards and requirements. 

Kevin Richardson, Chairman of the Board and CEO states, “We are all satisfied, and relieved, to have successfully passed these exhaustive rounds of quality system and product audits.  The many auditors involved in these exercises were very complimentary of our systems for controlling product and services.  I am proud to say that our quality systems can stand up against the best of the industry.  And I am even more proud to say that SANUWAVE’s employees are the basis of this success.  SANUWAVE builds on its foundation of Quality by tapping into its customer relationships and their clinical experiences and combining its continuous evolving expertise in advancing technologies. Our goal is to improve existing products and to seek new methods to improve the Quality of Life for patients. We are also seeking ways that enhance and extend the clinicians’ treatment boundaries. SANUWAVE’s products, particularly dermaPACE® System and orthoPACE® System achieve clinical effectiveness while minimizing healthcare costs.”  Mr. Richardson continued, “Achieving these goals involves an intricate network of processes and systems tying together elements involving Research and Product Development, Operations, Logistics, Production, Supply Chain, Customer Service and Training, Clinical Research, and other key functions. These processes are maintained and controlled via interdependent, documented systems with over-arching goals of excellence and continuous improvement.”

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 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.

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.

Contact:

Millennium Park Capital LLCChristopher Wynne312-724-7845cwynne@mparkcm.com

SANUWAVE Health, Inc.Kevin Richardson IICEO and Chairman of the Board978-922-2447investorrelations@sanuwave.com