Biologics

DermaPace Technology Suggests Promising Outcomes of Acoustic Pressure Shockwave Treatment for Venous Leg Ulcers (VLU)

SUWANEE, GA, March 08, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV), an emerging medical technology company focused on the development and commercialization of noninvasive, biological response activating devices in regenerative medicine, announces the publication of research that investigated the use of the dermaPACE® System in the treatment of Venous Leg Ulcers (VLU) in a case study series.  The study, titled “Treating venous leg ulcers with Extracorporeal Shockwave Technology (ESWT)” by Charne Miller (LaTrobe University), Suzanne Kapp (University of Melbourne), Jade Green (LaTrobe University), William McGuiness (LaTrobe Alfred Health Clinical School), and Michael Woodward (Austin Health/University of Melbourne), appeared in Wounds International 2017, Volume 8 Issue 3.  The case series was implemented at a medical professional lead, multidisciplinary outpatient wound clinic in Melbourne, Australia.

The case study series consisted of 6 patients, meeting eligibility criteria, presenting with venous leg ulcers (VLU) and who agreed to receive the dermaPACE treatment.  In order to better understand wound response to dose and energy, treatment selection used the two highest energy settings on the dermaPACE System, delivered at a frequency of 240 pulses/min. The shockwave pulse count was a function of wound area (cm2) with larger wounds requiring more shockwaves for treatment and thus longer time per therapy session than smaller wounds. The protocol used recommended one treatment delivered each week for 10 weeks.

Positive wound healing effects were observed for the majority of patients receiving ESWT.  At the conclusion of the case series the majority of wounds were either healed or healing was anticipated in a subsequent visit.

  • Patient 1 received 5 treatments over the course of 5 weeks, the wound reduced in size from 7 cm2 to 1 cm2 at the final treatment.
  • Patient 2 received 8 treatments over the course of 11 weeks, the wound, with an initial area of 2.5 cm2 at the time of the first treatment, was completely closed by week 16.
  • Patient 3 received 4 treatments over approximately 2 months.  Within 2 weeks of the first treatment, the wound had new areas of epithelialization tissue.  By the end of two months, the wound had epithelialized 100%.
  • Patient 4 received 4 treatments over a 6 week period.  By seven weeks post-initial treatment, the wound was documented as near-closure.
  • Patient 5 received only 1 treatment but continued to receive alternative modalities for treatment over a 5 week period.  In this time, the wound reduced in size from 2.5 cm2 to 1.5 cm2.
  • Patient 6 received a total of 3 treatments over a 3 week period.  The wound size at the first treatment was 1.5 cm2 and increased to 2.5 cm2 in the first two weeks.  By the last treatment, the wound presented with a reduction in the extent of hypergranulation and healthier wound margin.

The purpose of this case series was to expand evidence regarding the viability and the concurrent healing outcomes when using ESWT to treat venous leg ulcers.  The capacity to deliver the scheduled weekly treatments was not, however, achieved in any instance. Participants did find the treatment to be acceptable. Pain was reported only twice and was concurrent to reports of wound pain.

The active treatment itself would typically last for only 2-3 minutes with preparation and clean up also requiring only approximately additional five minutes of time, making ESWT an extremely practical therapy to implement in a busy clinic environment. However, the capacity to see patients weekly was difficult to realize for a variety of reasons.  This case study series is one of the first to document the use of dermaPACE in “real-life” conditions and not under the controlled settings seen in typical clinical investigations.  This study represents a low level of evidence regarding the viability and effect of ESWT in treating venous leg ulcers. The method which is characterized by a small sample and the absence of a comparison group represent limitations in comparison to more rigorous research methodologies. However, the case series is an appropriate research design for a burgeoning area of clinical enquiry, where questions regarding feasibility, acceptability, and effectiveness remain.

Suzanne Kapp (Visiting Academic, The University of Melbourne/ Honorary Clinical Study Coordinator, Wound Clinic Austin Health) commented, “The treatment can be easily implemented for clinicians, and was generally acceptable for patients.  We were pleased to see positive wound healing outcomes for the majority of participants.  We see the results from this small sample study as the first step in an evolving program of scientific study that will refine the treatment regimen and adopt more rigorous research designs.”  Adds Charne Miller, Senior Lecturer, LaTrobe University, “The results from this small sample are very encouraging.  It is one of the most promising case series we’ve conducted in terms of wound progress and feasibility. dermaPACE certainly warrants further investigation.”

Kevin A. Richardson II, CEO of SANUWAVE, stated, “We initiated this small case series study to attempt to better understand the response of VLUs to varied energy and shock count delivery.  The results were much better than anticipated, especially where adherence to the defined protocol was limited.  This small example is the first to document the vast series of issues clinicians face in real-life clinical settings.  This furthers our strong belief that dermaPACE will fill an unmet need in the wound care community to provide safe, effective, and fast treatment of wounds.  Enhancing wound management will help to improve the patient’s quality of life, reduce the medical risks associated with uncontrolled wounds, and also reduce health management costs.  SANWUAVE is excited to work with Dr. Kapp and the rest of the team in Melbourne to determine the next steps in developing a full treatment regimen.”

The dermaPACE System received US FDA clearance in late December for the treatment of Diabetic Foot Ulcers (DFU).  The DFU market is 1.5 million cases per year in the US.  The VLU market is larger at 2.5 million cases per year, but the overall costs are similar to the market size of DFU.  This is a natural extension as SANUWAVE expands its indications in the wound category.  This is a first step in preparing clinical work to expand our indication into VLU’s.  We are looking forward to expanding our clinical work with the folks in Australia and launching some work in the US later this year.

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave 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®, received US FDA clearance in December 2017 for the treatment of Diabetic Foot Ulcers.  dermaPACE is the only Extracorporeal Shockwave Technology (ESWT) device cleared or approved in the US for the treatment of DFUs.  Internationally, dermaPACE is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand, and South Korea.  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/PacificIn addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

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
Chairman of the Board
978-922-2447
investorrelations@sanuwave.com
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Drue De Angelis

Drue is Managing Partner for The De Angelis Group, Executive Search firm exclusively for the Ortho & Spine industry.

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