SANUWAVE Health Significantly Strengthens Intellectual Property Portfolio with Multiple Important Patent Grants for Its Shockwave Technology

US and International Patents Fortify dermaPACE Patent Position in Wound Care and Highlight its Innovation

SUWANEE, GA, Nov. 06, 2020 (GLOBE NEWSWIRE) -- via -- SANUWAVE Health, Inc. (OTCQB: SNWV), focused on the development and commercialization of a robust and innovative advanced wound care product portfolio for the repair and regeneration of skin and vascular structures, announced today that the Company has significantly strengthened its intellectual patent portfolio with the grants of a number of patents from the United States Patent and Trademark Office (USPTO) for the dermaPACE® System that further protect its unique and innovative shockwave technology in wound care.  In addition, the Company was also granted a patent related to the dermaPACE® System from IP Australia. 

"At SANUWAVE, we have long recognized the unique value that our non-invasive, shockwave technology provides in healing chronic wounds and these patents reinforce this belief, further demonstrating the proprietary nature of our technology and its innovation," stated Kevin A. Richardson, II, Chairman and Chief Executive Officer of SANUWAVE Health.  "We believe that our intellectual property portfolio will provide our products with long-term market protection and will add significantly to our shareholder value."

The following new patents related to the dermaPACE® System have recently been granted to SANUWAVE Health:

·                  U.S. Patent 10,769,249, which is titled, “Distributor Product Programming System.”  This U.S. patent covers a system for controlling and monitoring service activities by authorized SANUWAVE distributors from around the world at their facilities.  This is a license-based and remotely operated process that is already used in South Korea, Italy, and will be used in Brazil, for their local applicator refurbishment business.  The patent has 20 claims and will expire on February 24, 2038.

·                  U.S. Patent 10,569,106, which is titled, “Tissue Disinfection with Acoustic Pressure Shock Waves.” This U.S. patent covers the medical systems that can be used for infection treatments for a protruding appendage of a human or animal body affected by harmful pathogens as bacteria, viruses, funguses and other micro-organisms.  This patent is specifically related to treat an infected toe, finger, tail, nose, or a bovine, ovine and caprine teat or udder, to eliminate infection and its deleterious effects.  The patent has 19 claims and will expire September 28, 2038.

·                  Australian Patent 2016250668, which is titled, “Tissue Disinfection with Acoustic Pressure Shock Waves.”  This Australian patent covers the medical systems used to perform infection treatments for a protruding appendage of a human or animal body affected by harmful pathogens as bacteria, viruses, funguses and other micro-organisms.  The medical systems covered by this patent could treat an infected toe, finger, tail, or nose.  Furthermore, the treatments can be applied specifically for bovine, ovine and caprine teat or udder infections related to mastitis.  The patent has 20 claims and will expire April 22, 2036.

These patents join 8 U.S. patents and 5 foreign patents already granted to SANUWAVE Health related to the dermaPACE® System.  In addition, SANUWAVE Health has more than 12 patent applications pending in the U.S. and foreign countries relating to the dermaPACE® System.

The following new patents related to other applications for the Company’s shockwave technology have recently been also granted to SANUWAVE Health:

·                  U.S. Patent 10,639,051, which is titled, “Occlusion and Clot Treatment with Intracorporeal Pressure Shock Waves.”  This U.S. patent covers the devices that can be used for the treatment with our technology of possible occlusions and blood clots for blood vessels.  This is an intracorporeal approach using a catheter-based system, which has at its distal end shockwave elements able to direct their energy towards vessel occlusions or blood clots.  The patent has 20 claims and will expire September 29, 2031.

·                  U.S. Patent 10,562,793, which is titled, “Systems and Methods for Separating Heavy Water from Normal Water Using Acoustic Pressure Shock Waves.”  This U.S. patent covers the systems and methods used to separate heavy water from normal water for nuclear power plants, which is necessary for normal nuclear plants processing or for decontamination after nuclear accidents, as the one from Fukushima Daiichi Nuclear Plant from Japan.  The patent has 20 claims and will expire August 8, 2036.

“We continue to bolster our intellectual property estate and these grants represent the culmination of many years of work and reflect our commitment to building a fortress of protection around our shockwave technology both as a deterrent to would-be competitors and as a means to expand the innovation of our shockwave systems’ components in different medical and non-medical fields of applications,”  commented Iulian Cioanta, Ph.D., Chief Science and Technology Officer of SANUWAVE Health.  “Our broad intellectual property estate, including the granted patents announced today, will protect the innovative medical treatments we are bringing to patients suffering with recalcitrant and hard-to-heal wounds.” 

About the dermaPACE® System

The dermaPACE® System is a novel medical system based on shockwave technology, which has been used for nearly 30 years in lithotripsy procedures (destruction of kidney stones) and later in orthopedic treatments.  These early lithotripsy and orthopedic devices provided the earliest evidence that there was an effect on wound healing. Pulsed Acoustic Cellular Expression (PACE®) Technology was developed based on this evidence, and the dermaPACE® System is the first to utilize PACE-specific proprietary protocols for wound treatment.  The dermaPACE® System treatment must be administered by a healthcare professional.  The dermaPACE® System is cleared by the U.S. Food and Drug Administration (FDA) for the treatment of diabetic foot ulcers (DFU) and it is the first and only system based on focused electrohydraulic shockwave principle cleared by the FDA for such indication.   For international markets, the dermaPACE® System is CE Marked in Europe for advanced wound care indications and in Canada carries a Health Canada Medical Device class II License. The dermaPACE® System is currently licensed or approved for advanced wound care indications in Brazil, Mexico and dozens of countries and regions around the world. 

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (OTCQB:SNWV) () is focused on the research, development, and commercialization of its patented noninvasive and biological response activating medical systems for the repair and regeneration of skin, musculoskeletal tissue, and vascular structures.  Through its recent acquisition of Celularity’s UltraMIST® assets, SANUWAVE now combines two highly complementary and market-cleared energy transfer technologies and two human tissue biologic products, which creates a platform of scale with an end-to-end product offering in the advanced wound care market. 

SANUWAVE’s portfolio of regenerative medicine products and product candidates activate tissue regeneration biological signaling and angiogenic responses, producing new vascularization and microcirculatory improvement combined with tissue growth which helps restore the body’s normal healing processes. SANUWAVE applies and researches its patented energy transfer technologies in wound healing, orthopedics, biofilms eradication, plastic/cosmetic and cardiac/endovascular conditions.

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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

Anne Marie Fields

Managing Director

Rx Communications Group