Symposia and Posters Presenting Compelling Clinical Evidence in Treating Diabetic Foot Ulcers With dermaPACE®System

Suwanee, GA - (NewMediaWire) - October 16, 2019 - SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to provide an update of current clinical events and news involving the company’s dermaPACE®System, the only shockwave product cleared by FDA for the treatment of Diabetic Foot Ulcers (DFUs).  The dermaPACE®System is by far the most studied shockwave product on the market for wound indications; having more than 16 peer-reviewed articles, including the two most recently published by Journal of Wound Care (JWC) discussing the DFU randomized, double-blinded, parallel-group, sham-controlled, multicenter, 24-week pivotal clinical trials, and over 33 abstracts and posters.  This work has established a strong effectiveness and safety profile and helped us gain a solid understanding of how DFUs respond to dermaPACE®System treatment through increased perfusion, reduction in inflammation, accelerated wound area reduction, and wound healing.  SANUWAVE is committed to remain at the forefront of wound care research involving the company’s proprietary Pulsed Acoustic Cellular Expression (PACE®) technology.  The company just concluded a successful exhibition at the Symposium of Advanced Wound Care (SAWC) Fall 2019 in Las Vegas, NV.  Two posters and an Industry Supported Symposia were presented with SANUWAVE’s dermaPACE®System as the subject product.

SANUWAVE sponsored an Industry Supported Symposium (“ISS”) titled:  

“Investigating the Effects of Focused Electrohydraulic Shockwave Therapy in the Treatment of Diabetic Foot Ulcers: A Panel Discussion.”  The presentation and panel discussion was headed by Oscar M. Alvarez, PhD, CCT, FAPWCA Director University Hospital Wound Care and Mark S. Granick, MD, FACS Professor of Surgery Division of Plastic Surgery Medical Director University Hospital Wound Care, both of whom are affiliated with Rutgers New Jersey Medical School.Also, on the panel was Jayesh B. Shah, MD, MHA, FACHM, FUHM, FACP, FAPWCCA, CWSP Assistant Professor Division of Community and Family Medicine UT Health.

 

The objectives of the ISSwere to investigate the effects of focused electrohydraulic shockwave therapy on local skin perfusion and healing of diabetic foot ulcers.  The panel reviewed recent gold standard study results on the safety and efficacy of SANUWAVE’s dermaPACE®System focused electrohydraulic shockwave therapy in the treatment of diabetic foot ulcers.  The panel also explored real-world case studies, including the work Drs. Granick and Alvarez are conducting, illustrating the use of focused electrohydraulic shockwave therapy for healing diabetic foot ulcers and measuring the increased rates of perfusion that are being observed after patients’ wounds are treated with dermaPACE®System.  Dr. Shah, who has been an early adopter of the dermaPACE®in his practice, discussed the excellent results he is observing on patients treated with the dermaPACE® System.  There was standing-room only in the meeting hall with over 130 clinicians attending the presentation, which was roundly considered a success in providing educational value for this newest of wound care technologies.

 

Additionally, Dr. Windy Cole, DPM, Adjunct Professor and Director of Wound Care KSUCPM and Medical Director, UH Ahuja Wound Center presented a poster titled: “The Use of Non-Invasive Pulsed Acoustic Cellular Expression System to Promote Angiogenesis in Chronic Wounds.”  This case series discussed results to date of the objective to measure and monitor tissue oxygen saturation levels before and after a treatment regimen using the dermaPACE®System on DFUs.  Measurement of hemoglobin levels, associated with tissue oxygenation, was done via the Snapshot NIRS device from Kent Imaging. The on-going series reported wound improvement as measured by wound area reduction and increased granulation, while also exhibiting an improvement in tissue oxygenation by 17.3%.  To date, 10 patients have been treated, 4 with complete healing during the 5-week period and 6 with substantial wound area reduction.

Kevin Richardson, Chairman of the Board and CEO of SANUWAVE, stated, “SANUWAVE’s attendance at SAWC Fall 2019 continues a whirlwind of the company’s attendance at recent trade shows.  We just finished a successful attendance at Wounds Canada. We were very pleased with the volume of booth traffic at both shows.  We are finding that the wound care professionals are open and eager to learn about our focused electrohydraulic ESW technology presented in the form of the dermaPACE®System.  We are extremely fortunate that some of our technology’s early adopters are also leading voices in the wound care industry.  Drs. Granick, Alvarez, Shah, and Cole are leaders in the advancement of wound care and having them use and adopt our technology is an honor.”  Mr. Richardson continued, “We are going straight from SAWC to exhibiting at Diabetic Foot Conference (DFCon) in Los Angeles, CA beginning October 17 where, in addition to our booth, there will be posters and another discussion panel with leading voices in the wound care arena. After just nine months since our commercialization plan went into full gear, we are extremely pleased to be ahead of our plans for the adoption of dermaPACE®System as a key technology in the management and healing of DFUs.  This is just the beginning though. Other peer-reviewed articles will be forthcoming based upon on-going research in perfusion measurement.  Additionally, we expect to begin enrollment of our follow-on study supporting our DFU indication.  And of course, we fully expect to be active in 2020 in setting the clinical groundwork for expansion into new indications.”

Mr. Richardson’s comments reflect SANUWAVE’s busy pace of attending this Fall’s wound care trade shows, with the company’s attendance at The Diabetic Foot Conference (DFCon), the premier international, interdisciplinary diabetic foot conference in North America; come visit us at Booth 1.  SANUWAVE has a full agenda planned for this conference as well with:

·     A panel discussion on Saturday, October 19 titled “dermaPACE®Role in Avoiding Amputation and Treating DFU” with Dr Brian Lepow, Dr. Lee C. Rogers, and Dr. Anna Sanchez as the panelists and moderated by Dr. Perry Mayer. 

·     Two posters being presented, the first by Dr. Perry Mayer “Extracorporeal shockwave therapy (ESWT)-PACE technology: Micro-Vascular Stimulation Post-Amputation Applied to Incision Lines Promotes Healing and Reduces Edema - Avoiding Extended Wound Care or the Need for Further Surgical Intervention” and the second by Dr. Brian Harper titled “ESWT -PACE Technology Utilizes High-Energy Acoustic Pressure Shockwaves with Ultimate Goal of Regenerating Healthy Tissue in Chronic Foot Ulcers in a Community Clinic”. 

 

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 LLC
Christopher Wynne
312-724-7845
cwynne@mparkcm.com

SANUWAVE Health, Inc.
Kevin Richardson II
CEO and Chairman of the Board
978-922-2447
investorrelations@sanuwave.com