SANUWAVE Health Presents dermaPACE System Treatment Study Results Showing Enhanced Localized Wound Tissue Oxygenation

Rhea-AI Summary

SANUWAVE Health, Inc. (OTCQB:SNWV) recently reported promising results from a clinical case series on its dermaPACE System, an FDA-cleared treatment for diabetic foot ulcers. The study, published in the American Journal of Nursing Science, showed a 25% increase in tissue oxygen saturation and a 46.7% full wound closure rate among patients over four weeks. This signifies the system's effectiveness in enhancing wound healing and could transform management strategies for chronic wounds in diabetic patients, impacting around 30.3 million Americans.

Positive

• 25% increase in tissue oxygen saturation in wounded patients.
• 46.7% of treated wounds achieved full closure.
• Significant improvement in wound healing metrics.
• Supports SANUWAVE's position in advanced wound care market.

Negative

• None.

SUWANEE, GA / ACCESSWIRE / May 27, 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 focused, shockwave systems in the non-medical field today presented results from a clinical case series that demonstrated improved wound healing when treated with its FDA-cleared, non-invasive pulsed acoustic cellular expression system dermaPACE® System. The study: A Non-invasive Focused Extracorporeal Shockwave Therapy System Promotes Increased Tissue Oxygen Saturation in Chronic Wounds in Persons with Diabetes, was published in the American Journal of Nursing Science in May 2021.

The study was conducted in a clinical practice setting and concentrated on 15 wounds from 14 patients with a chronic foot or ankle wound and a diagnosed history of diabetes wounds observed between January 2019 and December 2019. The wounds that were treated had an average age of more than 12 weeks. Each patient was run through a screening period and those that entered the study had failed to achieve at least a 50% wound area reduction in four weeks of treatment with standard care. The main objective of the study was to observe the effects of dermaPACE System's focused shockwaves on tissue oxygen saturation within the wound bed as measured using near-infrared spectroscopy. Secondary objectives were to monitor the wound response to the treatment.

Scientists and researchers have been examining the effects of external physical force manipulation on tissue to improve wound healing. Focused Extracorporeal Shock Wave Therapy (F-ESWT) is a non-invasive treatment that can be safely and easily performed in the outpatient setting as an adjunctive therapy. SANUWAVE's dermaPACE system is an FDA-cleared F-ESWT.

Treatment with the dermaPACE System over four weeks (one treatment per week) resulted in all patients demonstrating a statistically significant increase in tissue oxygen saturation within the wound bed, a key component of wound healing. Wound bed tissue oxygen saturation increased approximately 25% (P=0.0008). Additionally, the results showed all 15 wounds demonstrated a decrease in wound area and seven, or 46.7%, of the wounds experienced full wound closure (P=0.0007).

The results of this case study are another indication that treatment of Diabetic Foot Ulcers with the dermaPACE System prepares the wound bed via oxygenation and neo-vascularization, facilitating accelerated wound resolution via the body's natural healing process or preparing the wound to more readily respond to other advanced healing modalities.

Kevin Richardson, Chairman and Chief Executive Officer said, "Diabetes is a disease that impacts 30.3 million Americans. Long term complications include damage to blood vessels which can lead to amputations and morbidity, particularly in lower limbs. Results from this study provide statistically significant data that using our dermaPACE System can improve blood circulation, increase tissue oxygenation, enhance cell proliferation, and accelerate wound healing.

"We believe our Energy First, non-invasive and biological response-activating medical systems provide doctors and patients an improved method to treat wounds. Doctors have the ability to track and measure the wound healing process in a cost-efficient manner. Patients spend less time in treatment and can improve quality of life when suffering from chronic ulcerations and wounds."

To read the full study, please visit sciencepublishinggroup.com.

About SANUWAVE Health
SANUWAVE Health (OTCQB:SNWV) is focused on the research, development, and commercialization of its patented, Energy First non-invasive and biological response-activating medical systems for the repair and regeneration of skin, musculoskeletal tissue, and vascular structures.

SANUWAVE's end-to-end wound care portfolio of regenerative medicine products and product candidates help 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 more information, please 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.

Investor Relations Contact
Brian M. Prenoveau, CFA
Managing Director
MZ Group - MZ North America
(561) 489-5315
SNWV@mzgroup.us
www.mzgroup.us

SOURCE: SANUWAVE Health, Inc.

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FAQ

What are the clinical results of SANUWAVE Health's dermaPACE System?

The clinical results showed a 25% increase in tissue oxygen saturation and a 46.7% full wound closure rate.

When was the study on the dermaPACE System published?

The study was published in May 2021 in the American Journal of Nursing Science.

What is the significance of the dermaPACE System for diabetic patients?

It improves wound healing, potentially benefiting the 30.3 million Americans affected by diabetes.

What is the stock symbol for SANUWAVE Health?

The stock symbol for SANUWAVE Health is SNWV.

What type of therapy does the dermaPACE System utilize?

It utilizes Focused Extracorporeal Shock Wave Therapy (F-ESWT) for wound treatment.