Tue, 15 Jun 2021

Patents and patent applications provide additional coverage for the company's shockwave and ultrasound technologies in medical and non-medical fields

SUWANEE, GA / ACCESSWIRE / May 11, 2021 / SANUWAVE Health, Inc. (OTCQB:SNWV), a leading provider of next-generation advanced wound care medical systems for the repair and regeneration of skin and vascular structures and the research for new applications for shockwave systems in the non-medical field, announced today the patent activity for the full year 2020 and the first quarter of 2021.

SANUWAVE continues to invest in the development of the company's technologies and the associated intellectual property with such advances. The patent applications for SANUWAVE continued to grow in 2020, despite the difficult year for many. SANUWAVE has multiple initiatives underway to further develop and monetize the company's non-wound care patents.

For the shockwave technology incorporated in the dermaPACE® and orthoPACE® Systems the following new patents were issued:

  • US 10,562,793 titled 'Systems and Methods for Separating Heavy Water from Normal Water Using Acoustic Pressure Shock Waves'. This US patent covers the systems and methods used to separate heavy water from normal water form nuclear power plants. The patent has 20 claims and it will expire in August 08, 2036.
  • US 10,569,106 titled 'Tissue Disinfection with Acoustic Pressure Shock Waves'. This US 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 treatment of an infected toe, finger, tail, nose, or a bovine, ovine and caprine teat or udder, to eliminate infection and its delirious effects. The patent has 19 claims and it will expire in September 28, 2038.
  • US 10,639,051 titled 'Occlusion and Clot Treatment with Intracorporeal Pressure Shock Waves', covers the medical systems 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 occlusion or blood clots. The patent has 20 claims and it will expire in September 29, 2031.
  • US 10,769,249 titled 'Distributor Product Programming System'. This US 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. The patent has 20 claims and it will expire in February 24, 2038.
  • US 10,874,124 titled 'Acoustic Pressure Shock Waves Used for Meat Processing' covers the methods for using the shockwaves in cleaning contaminants from the animal carcasses on a processing line. This patent teaches the cleaning with shockwaves when animal carcasses are submerged in a liquid or travel on a conveyor through air in front of a mist that transmits the shockwaves towards the carcasses. The patent has 21 claims and it will expire in January 02, 2038.
  • US 10,888,715 titled 'Acoustic Pressure Shock Waves Used for Personalized Medical Treatment of Tissue Conditions'. This US patent covers the computerized medical systems capable to adjust a medical treatment using patient's comorbidities, lifestyle habits, and the characteristics of the diseased tissue. The adjustment of different setting parameters based on individualized patient parameters produces a personalized medical treatment for each patient. The patent has 26 claims and it will expire in May 12, 2039.
  • EP 3461438 titled 'Combined Intracorporeal and Extracorporeal Shock Wave Treatment System', includes patents in the United Kingdom, Germany, France and Netherlands as designated countries. This patent covers the use of extracorporeal shockwaves and subcutaneous/intracorporeal shockwaves in combination for dissolving fat deposits in human and animal bodies. The patent has 7 claims and it will expire in July 08, 2030.
  • AU 2016250668 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 it will expire in April 22, 2036.

These 11 new patents (six in the US and a total of five International patents for five different countries) bring the total number of active patents and patent applications to 103, with 69 in the medical field and 34 in the non-medical field.

Through the acquisition of the UltraMIST® assets in 2020, SANUWAVE has added the patents and patent applications related to the non-contact and low frequency ultrasound technology incorporated into the UltraMIST System. The patent portfolio covers specific constructions for ultrasound systems, combination systems, drug delivery and methods to apply such ultrasound technology for different medical affliction as various wounds, pain, inflammation, etc. This robust patent portfolio includes a total of 47 active patents and patent applications, with 17 in the US and 30 internationally. The process to transfer these patents and patent applications in the SANUWAVE name as assignee was a primary activity in 2020 and the beginning of 2021. The process is completed with the United States Patent and Trademark Office (USPTO) and is in the late stages for the international fillings. There are 10 pending patent applications and the work on at least two new patent applications has been started by the company.

Dr. Iulian Cioanta, SANUWAVE's Chief Science and Technology Officer stated, 'At SANUWAVE, our goal is to improve the effectiveness of our technologies and to produce novel approaches that benefit patients, medical professionals and our clients in general. Based on this philosophy, these new patents related to shockwave technology and the addition of the portfolio of UltraMIST patents and patent applications maintains and provides additional coverage for our proprietary technologies against competition.'

'SANUWAVE is at the forefront of enhancing the possibilities of the shockwave and ultrasound technologies through finding new applications and optimizing their output based on the targeted market,' stated Kevin A. Richardson II, SANUWAVE's Chairman of the Board and Chief Executive Officer. 'The addition of the UltraMIST-related patent portfolio to our more than one hundred patents and patent applications for shockwave technology is clearly a step forward for SANUWAVE in its ENERGY FIRST approach. We strive to advance the treatment of wounds and explore new avenues to apply the ultrasound and shockwave technologies in both medical and non-medical fields.'

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 FDA cleared 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 UltraMIST® System
UltraMIST® System is providing through a fluid mist a low-frequency, non-contact, and pain free ultrasound energy deep inside the wound bed that promotes healing from within. The ultrasound acoustic waves promote healing by reducing inflammation and bacteria in the wound bed, while also increasing the growth of new blood vessels to the area. The UltraMIST® System treatment must be administered by a healthcare professional. This proprietary technology has been cleared by the U.S. Food and Drug Administration (FDA) for the promotion of wound healing through wound cleansing and maintenance debridement combined with ultrasound energy deposited inside the wound that stimulated tissue regeneration. The UltraMIST® System has been used in thousands of patients for more than a decade. For international markets, the UltraMIST® System is CE Marked in Europe.

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 the UltraMIST® assets, SANUWAVE now combines two highly complementary and market-cleared energy transfer technologies used in dermaPACE® and UltraMIST® Systems and two human tissue biologic products (Biovance® and Interfyl®), 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, orthopedic/spine, plastic/cosmetic and cardiac/endovascular conditions.

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.

SANUWAVE Health, Inc.
Kevin Richardson II
Chairman and Chief Executive Officer


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