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SANUWAVE Health Announces Distribution Agreement with Labb Solutions

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SANUWAVE Health, Inc. (OTCQB: SNWV) has announced an exclusive distribution agreement with Labb Solutions for its dermaPACE® and UltraMIST® systems in Turkey and select countries in Eastern Europe and the Middle East. The first ten dermaPACE systems have already been shipped to Turkey. These energy-based medical systems aim to enhance wound care by leveraging innovative technologies. The dermaPACE system, FDA-cleared for diabetic foot ulcers, utilizes Pulsed Acoustic Cellular Expression (PACE®) technology. Meanwhile, UltraMIST offers non-contact ultrasound treatments to promote healing.

Positive
  • Exclusive distribution agreement with Labb Solutions expands market reach in Turkey and select Eastern Europe and Middle East countries.
  • First ten dermaPACE systems have been ordered and shipped to Turkey, indicating immediate sales activity.
  • dermaPACE is FDA cleared for treating diabetic foot ulcers, positioning SANUWAVE favorably in advanced wound care.
  • Both systems utilize innovative energy transfer technologies, enhancing the company's product portfolio.
Negative
  • None.

SANUWAVE to Distribute dermaPACE® System and UltraMIST® System in Turkey and in Select Eastern Europe and Middle East Countries

SUWANEE, GA, March 19, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- 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 it has entered into an agreement with Labb Solutions to be the exclusive multinational distributor of the company’s dermaPACE and UltraMIST energy-base medical systems in Turkey, Georgia, Azerbaijan, Belarus, and Kazakhstan.

Kevin A. Richardson II, Chairman and Chief Executive Officer of SANUWAVE Health, commented, “We are very pleased to partner with Labb Solutions, a leader in Turkey and select countries from Eastern Europe and Middle East for the distribution of innovative medical technologies. This is clearly a step forward for SANUWAVE in its “Energy First” adoption and commercialization program in this particular region. We look forward to a very successful partnership.”

The first ten dermaPACE systems have been ordered and shipped to Turkey.

“We are extremely excited to partner with SANUWAVE Health to bring the innovative dermaPACE and UltraMIST Systems that use energy transfer therapies to physicians and wound care patients in Turkey and parts of the Middle East and Eastern Europe. There is a tremendous opportunity to impact the lives of patients and reduce the cost burden of chronic and acute wounds on the private and public healthcare systems,” stated Anar Aliyev, Director of Labb Solutions.  

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) (www.SANUWAVE.com) 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.

Contact:

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


FAQ

What is SANUWAVE Health's recent distribution agreement?

SANUWAVE Health has entered into an exclusive distribution agreement with Labb Solutions for its dermaPACE® and UltraMIST® systems in Turkey and selected countries in Eastern Europe and the Middle East.

Which regions are included in SANUWAVE's distribution partnership?

The distribution partnership includes Turkey, Georgia, Azerbaijan, Belarus, and Kazakhstan.

What technology does the dermaPACE® System utilize?

The dermaPACE® System uses Pulsed Acoustic Cellular Expression (PACE®) technology, based on shockwave technology.

Is the UltraMIST® System FDA cleared?

Yes, the UltraMIST® System is FDA cleared for promoting wound healing through ultrasound energy.

What are the initial sales figures for the dermaPACE® System?

The first ten dermaPACE systems have been ordered and shipped to Turkey.

SANUWAVE HEALTH INC

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