dermaPACE for diabetic foot ulcers

NewsBot · Sep 6, 2007

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Press Release:
SANUWAVE, Inc. announces conditional approval from the FDA of its
Investigational Device Exemption (IDE) application to begin a U.S. clinical trial of
the dermaPACE Device for the treatment of diabetic foot ulcers

SANUWAVE, Inc., a leading provider and developer of
Pulsed Acoustic Cellular Expression (PACETM) technology, announced today that it has received
conditional approval from the FDA to initiate a multi-center, prospective, randomized clinical
trial utilizing its novel dermaPACE device in the treatment of diabetic foot ulcers.
Conditions of the approval include timely response to minor questions raised by the FDA
following their review of the IDE package submission. The trial will be conducted at up to 10
sites within the United States. Patient selection and enrollment will begin following site
Institutional Review Board (IRB) approvals.
Maria Siemionow, MD, PhD, Director of Plastic Surgery Research at the Cleveland Clinic
Foundation in Cleveland, OH, will act as Medical Monitor for the clinical trial.
According to Peter Sheehan, M.D., a senior faculty member at the Mount Sinai School of
Medicine and a member of the Board of Directors of both the American Diabetes Association
and the Wound Healing Society, “In the United States, we have 21 million people with
diabetes and 54 million with pre-diabetes, placing 25% of our population at risk for
complications of diabetes. So when you factor in that 15% of people with diabetes can expect
to get a non-healing ulcer in their lifetime, there’s obviously a big clinical need. Any
intervention should prove cost effective. It costs roughly $60,000 for lower limb amputation,
and the hospitalization alone can cost $16,000 - $20,000 for a patient with a diabetic foot
ulcer.”
Christopher M. Cashman, SANUWAVE President and CEO, commented, “IDE approval is a
tremendous step towards Pre-Market Approval (PMA) for dermaPACE in the U.S., and is a
significant milestone accomplishment for SANUWAVE. The dermaPACE device is already
commercialized to the European community and we continue to see excellent results and
acceptance. We are looking forward to treating our first patients in the U.S.”
The biological working mechanism of dermaPACE is based on the application of high energy
pulsed acoustic waves to the affected area. PACE produces stresses at a cellular level which
lead to an observed immediate increase in microcirculation and a signal for the cellular release
of specific proteins (cellular expression) including angiogenic growth factors that have been
clinically shown to result in new supportive blood vessel growth, also known as
neovascularization. The combined effect has been shown in animal studies and human pilot
studies to have a positive outcome on chronic wound conditions.
About SANUWAVE, Inc.
SANUWAVE, Inc., is a global medical technology company focused on the development and
utilization of Pulsed Acoustic Cellular Expression (PACE) technology for advanced wound care,
orthopedic, cardiovascular and spine/neurological conditions. Headquartered in Alpharetta, GA
with international offices in Lengwil, Switzerland and Tokyo, Japan, SANUWAVE designs,
manufactures, markets, and services its industry leading products worldwide. SANUWAVE’s
dermaPACE has the European Community’s CE Mark approval for use in acute and chronic
defects of the skin and subcutaneous soft tissue. The company’s OssaTron® is the standard of
care for electro-hydraulic ESWT (Extracorporeal Shock Wave Technology), and is approved for
use by the FDA for chronic plantar fasciitis and chronic lateral epicondylitis, more commonly
known as heel pain and tennis elbow, respectively. OssaTron and EvoTron® have the
European Community CE Mark approval for a variety of soft tissue and bone musculoskeletal
indications including plantar fasciitis, epicondylitis, calcifying tendonitis, achilles
tendonopathies, delayed fracture healing, avascular necrosis (AVN), and osteochondrosis
dissecans (OCD). SANUWAVE’s veterinary business promotes VersaTron® ESWT for equine
applications and VersaTron 4 Paws® for use on small animal maladies such as degenerative
joint disease. SANUWAVE is undertaking extensive research into the biological mechanisms
and cellular effects of ESWT and PACE, to include anti-inflammatory response, angiogenesis
promotion, and bactericidal capabilities.
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NewsBot · Dec 15, 2009

Press Release:
The Microcirculatory Effects of SANUWAVE’s PACE Technology Explained in Presentation by Joanna Cwykiel of Cleveland Clinic

SANUWAVE Health, Inc., an emerging medical technology company focused on the development and commercialization of non-invasive, biological response activating devices in the regenerative medicine area, announced that the cellular and subcellular effects of PACE™ technology were described during a lecture presented this past weekend. Joanna Cwykiel, MSc of Cleveland Clinic conducted the oral presentation titled, Pulsed Acoustic Cellular Expression, at the 10th Annual Wound Healing: Science and Industry conference held December 11th through 13th in St. Thomas, U.S. Virgin Islands.

The presentation discussed preclinical work regarding the effects of Pulsed Acoustic Cellular Expression (PACE™) technology on microcirculation. Using microscopic techniques in a muscle flap model, the research assessed the effect of PACE™ treatment on microcirculatory hemodynamics, neovascularization and interactions between specialized white blood cells of the immune system (leukocytes) and cells lining the interior surface of blood vessels (endothelial cells).

The study found that a PACE™ treatment of 500 impulses was superior to a treatment of 200 impulses for the same tissue area. 500 impulses resulted in immediate activation of leukocytes while 200 had no effect. The increased leukocyte activity after 500 impulses contributed to cellular interactions within the blood vessels and expression of proangiogenic growth factors, VEGF and vWF. These growth factors are precursors of new blood vessel formation that is necessary to promote wound healing. Pronounced growth factor activity was seen within 24 hours of PACE™ treatment, supporting earlier findings that PACE™ technology quickly initiates a cascade of cellular-level events to improve microcirculation and promote neovascularization.

Ms. Cwykiel’s presentation also included a summary of internationally published data that suggests additional promising benefits of acoustic pressure waves applied in the shockwave spectrum. Wang et al. demonstrated wound healing in a diabetic rat model through increased perfusion and regeneration, while Davis et al. found suppression of inflammatory immune responses. Both studies support PACE™ technology for accelerated wound healing. A pre-operative PACE™ treatment study by Reichenberger et al. reported results of enhanced skin flap survival when administering PACE™ treatment prior to surgical procedures, lending credibility to the use of PACE™ technology to improve outcomes for skin flap patients through proactive tissue preconditioning. These recent laboratory studies show PACE™ treatment is compatible with wound healing by increasing microcirculation, decreasing inflammation, and stimulating cell growth and proliferation.

Christopher M. Cashman, President and Chief Executive Officer of SANUWAVE said, “We are excited about the full breadth of research conducted at Cleveland Clinic. Their work has greatly advanced our scientific understanding of PACE™ technology and confirms our belief that PACE™ technology has a wide range of clinical applications. Their most recent microcirculatory effect findings validate the protocol that we have found to be effective in European clinical studies. We expect the dermaPACE™ IDE trial for the treatment of diabetic foot ulcers, for which we are on track to complete enrollment by the first quarter of 2010, to be equally successful.”

Joanna Cwykiel, MSc is a molecular biologist and research fellow at Cleveland Clinic in the Plastic Surgery Research Department headed by Maria Siemionow, M.D., Ph.D. She has presented at many conferences, including the American Association of Plastic Surgeons, Plastic Surgery Research Council, and the Diabetic Foot Convention.
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NewsBot · Apr 13, 2011

Press Release:
DERMAPACE PIVOTAL PHASE III CLINICAL TRIAL RESULTS FOR DIABETIC FOOT ULCER TREATMENT TO BE PRESENTED AT THE SYMPOSIUM ON ADVANCED WOUND CARE (SAWC) SPRING 2011

SANUWAVE Health, Inc. (OTCBB: SNWV) (www.sanuwave.com), an emerging medical technology company focused on the development and commercialization of noninvasive, biological response activating devices in regenerative medicine, today announced that study results from the Company’s pivotal Phase III, Investigational Device Exemption (IDE) clinical trial with dermaPACE® to treat diabetic foot ulcers will be presented in a podium presentation at the Symposium on Advanced Wound Care (SAWC) Spring 2011 taking place April 14 -17, 2011 in Grapevine, Texas.
Commenting on the upcoming presentation, Christopher M. Cashman, SANUWAVE’s President and Chief Executive Officer, said, “We are excited to share these highly positive and clinically relevant results from our dermaPACE pivotal Phase III clinical trial to a distinguished audience at SAWC, the largest annual gathering of wound care clinicians in the United States. These study results underscore the potential of dermaPACE, should the FDA approve dermaPACE through our PMA submission process, to change the clinical and economic landscape in diabetic foot ulcer healing through more efficient utilization of clinical resources, increased limb salvage, decreased overall healthcare costs and greatly improved patient quality of life.”
The presentation, entitled “Pulsed Acoustic Cellular Expression Technology in the Treatment of Diabetic Foot Ulcers: A Sham-controlled, Double-blinded, Randomized Clinical Trial,” will be delivered by Robert Galiano, M.D., a principal investigator in the study and Assistant Professor, Division of Plastic Surgery, Department of Surgery at the Northwestern University Feinberg School of Medicine, on Friday, April 15, 2011 between 4:45 – 5:45 p.m. (local time) in the Grapevine C room at the Gaylord Texan Hotel and Convention Center.

Dr. Galiano’s presentation will detail the clinical trial’s rigorous design and compelling outcomes. Top-line data were announced in December 2010 and reported that patients treated with dermaPACE were twice as likely to achieve 90% to 100% wound closure within 12 weeks of their initial dermaPACE treatment compared to patients randomized to receive Sham control, suggesting the potential of dermaPACE to be a novel, nonpharmacologic and noninvasive advanced wound healing modality.

“The scientific mechanism activated by dermaPACE technology has a direct and lasting impact on
wounds by immediately increasing blood perfusion and stimulating the body’s own angiogenic and
positive inflammatory wound healing responses,” noted Dr. Galiano. “This biological mechanism has a
direct and lasting impact on wounds by immediately increasing blood perfusion and stimulating the
body’s own angiogenic and positive inflammatory wound healing responses. The dermaPACE clinical
trial results provide the necessary clinical evidence to validate the benefits of such a mechanism when
combined with proper wound care.”

Study Design Relevance
Unlike many other chronic wound trials conducted in this diabetic patient population, there were two
important elements incorporated in the dermaPACE study design: double-blind (patient and principal
investigator) randomization, and elimination of the option to close the target ulcer surgically or by
other primary means. Maintaining the double-blind in this device trial restricted the knowledge of the
treatment assignment so not to influence how a patient was treated or maintained on study and
evaluated. This eliminated unintended human bias and qualifies this research as level 1 evidence,
allowing the results to be accepted at face value. By not allowing the clinical investigators to surgically
close the target ulcer in this study, the results provide a clear and unbiased view of the granulation
and epithelialization process attributable to dermaPACE alone.
Medical Need
Diabetes is common, disabling and deadly. In the U.S., diabetes has reached epidemic proportions.
According to the American Diabetes Association, about 27 million people (9% of the total U.S.
population) have diabetes, and nearly two million new cases are diagnosed in people aged 20 years
or older each year. If current trends continue, 1 in 3 Americans will develop diabetes at some point in
their lifetime, and those with diabetes will lose, on average, 10-15 years of life expectancy.
Importantly, up to 25% of people with diabetes will develop a diabetic foot ulcer, resulting in 3 million
diabetic foot ulcers annually in the U.S. alone. More than half of all foot ulcers will become infected,
thus requiring hospitalization, and 1 in 5 will require an amputation that carries a high risk of mortality.
According to the American Diabetes Association, by the year 2025 the prevalence of diabetes is
expected to rise by 72% to 324 million people worldwide.

About PACE®
PACE, defined as Pulsed Acoustic Cellular Expression, delivers high-energy acoustic pressure waves
in the shock wave spectrum to produce compressive and tensile stresses on cells and tissue
structures to promote angiogenic and positive inflammatory responses, and quickly initiate the healing
cascade. This results in revascularization and microcirculatory improvement, including the production of angiogenic growth factors, enhanced new blood vessel formation (angiogenesis), and the subsequent regeneration of tissue such as skin, musculoskeletal and vascular structures. PACE treatment triggers the initiation of an accelerated inflammatory response that speeds wounds into
proliferation phases of healing and subsequently returns a chronic condition to an acute condition to help reinitiate the body’s own healing response.
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NewsBot · Dec 27, 2011

Press Release:
Sanuwave dealt setback for medical device sales of new diabetic foot ulcer treatment
Dec 27, 2011

Georgia-based medical device sales company Sanuwave Health Incorporated has announced it has received a major deficiency letter from the Food and Drug Administration (FDA) in its attempt to market a new noninvasive therapy to treat diabetic foot ulcers.

Medical sales representatives know a warning letter could have a negative impact on a company's bottom line revenues, as the federal agency determines whether a medical device is commercially viable. In the case of Sanuwave's dermaPACE device, the FDA said its review of its premarket approval application (PMA) lacked important information to determine the product's safety.

Christopher M. Cashman, president and chief executive officer of Sanuwave, said the company will continue to work with the FDA to evaluate the safety and efficacy of dermaPACE next year.

"We will continue to work toward our goal of a positive approval decision from the FDA so we can bring this novel, promising treatment to the millions of patients who suffer from these debilitating, recalcitrant wounds," Cashman stated.

According to the American Academy of Family Physicians, diabetic ulcers are the most common foot injuries leading to lower extremity amputation, with the risk of amputation 15 to 46 times higher in diabetics than in people who do not have the metabolic disease.
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NewsBot · Jan 7, 2012

Press Release:
SANUWAVE Issued U.S. Patent for the Application of Acoustic Shock Waves Utilizing Its PACE Devices

SANUWAVE Health, Inc, an emerging medical technology company focused on the development and commercialization of noninvasive, biological response activating devices in regenerative medicine, today announced that the U.S. Patent and Trademark Office (USPTO) has issued the Company patent number 8,088,073, titled “Device for the Application of Acoustic Shock Waves.”

The patent has a term extending to June 2025 and is directed to an invention for an electrohydraulic shock wave device having novel features that may enhance the capabilities of the Company’s Pulsed Acoustic Cellular Expression (PACE®) technology platform. This patented invention for delivering shock waves into living tissue includes a multi-adjustable reflector contained within a tissue-contacting treatment applicator that allows adjusting the positions where shock waves are generated and delivered into the body with modifiable tissue penetration depths. The patent also offers the improvement of a fastening or “pivot” point within the applicator’s housing to enable the reflector to tilt in any direction, thus increasing the volume of tissue treated from a single applicator position.

“We are delighted to add this patent to our growing intellectual property portfolio, which will extend and consolidate our leadership position in the use of PACE technology for tissue regeneration," stated Christopher M. Cashman, President and CEO of SANUWAVE. “This patent protects the capability of our proprietary technology and has the potential to expand our treatment options, including the ability to target a wider variety of tissues in the pursuit of new clinical applications.”
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NewsBot · May 9, 2012

Press Release:
SANUWAVE Receives Conditional Approval from the FDA on Clinical Trial Plan for dermaPACE

SANUWAVE Health, Inc. today reported that the U.S. Food and Drug Administration (FDA) has granted conditional approval of its Investigational Device Exemption (IDE) Supplement for an additional clinical trial utilizing the Company's dermaPACE(R) device in the treatment of diabetic foot ulcers. The Company estimates the clinical trial could be completed and submitted in support of a Premarket Approval (PMA) application for dermaPACE in as early as 20 months from trial initiation, assuming such data to be collected meets the agreed upon statistical and clinical plan of success.

The Company worked closely with the FDA to develop the protocol and statistical plan that were submitted in the IDE Supplement. A substantial component of this work involved using Bayesian statistical principles to define the dermaPACE treatment benefit established in the Company's previously conducted pivotal study. Bayesian designs are supported by the FDA where there is strong prior evidence that can be incorporated into the clinical study design. By incorporating the prior positive information regarding complete wound closure after one treatment cycle to bear on the design of the additional study, substantially fewer patients should be required than would otherwise be the case while still ensuring adequate statistical power. This approach will save significant time and preserve scientific rigor.

Importantly, the study design allows for controlled interim monitoring of the data by an independent Data Monitoring Committee (DMC) to determine whether study success has been achieved. The first analysis for success is projected to occur after 90 patients (approximately 45 per arm) have completed the 12-week primary efficacy evaluation period. If study data achieves pre-defined statistical and clinical success criteria associated with wound closure favoring dermaPACE, then the clinical trial can be stopped, and the Company will submit an amendment to its current PMA for approval.

The clinical trial plan incorporates the same primary efficacy endpoint of complete wound closure at 12 weeks as was utilized in the recently completed pivotal trial. Similar to the previous trial, four (4) dermaPACE procedures will be administered during the first two weeks following subject enrollment. However, up to four (4) additional dermaPACE procedures can now be delivered bi-weekly between weeks 4 and 10 which the Company believes will increase the between-group difference in complete wound closure in favor of dermaPACE from that observed in the first clinical trial.

The Company has already identified clinical study sites and is in the process of qualifying them for participation. Patient enrollment is expected to begin once Institutional Review Board (IRB) approvals and appropriate funding to conduct the study are in place, which is forecasted to occur as early as the third quarter of this year.

Christopher M. Cashman, President and CEO of SANUWAVE, said, "As previously reported, we believe that an IDE Supplement is the most appropriate course of action to support our PMA for dermaPACE in the treatment of diabetic foot ulcers. The FDA's conditional approval of the IDE Supplement is a highly positive development in the approval process of dermaPACE for the U.S. market. This additional clinical trial provides a scientifically robust, yet potentially more expeditious pathway to validation of dermaPACE's safety and efficacy and subsequent FDA approval."

"We have worked diligently and openly with the FDA to develop the statistical plan and the protocol for the IDE Supplement while, in parallel, recruiting key investigational sites to perform this next clinical trial. The FDA's support of the study's Bayesian framework allows us to build upon the wound closure data previously demonstrated for dermaPACE. We are moving quickly toward our ultimate goal of obtaining FDA approval for dermaPACE and commercializing the technology in the U.S. where millions of people suffer from costly and debilitating diabetic foot ulcers," concluded Mr. Cashman.

Medical Need According to the Centers for Disease Control and Prevention (CDC), diabetes has reached an epidemic level in the U.S., with nearly 26 million American adults having diabetes, and an estimated 79 million more having pre-diabetes. The CDC also reports that, in 2010, nearly two million Americans aged 20 years or older were first diagnosed with diabetes. If current trends continue, 1 in 3 Americans will develop diabetes at some point in their lifetime, and those with diabetes will lose, on average, 10-15 years of life expectancy. The World Health Organization (WHO) projects that by the year 2030 the prevalence of diabetes is expected to double to 366 million people worldwide.

Importantly, as published in the Journal of the American Medical Association (JAMA) in 2005, up to 25% of people with diabetes will develop a diabetic foot ulcer in their lifetime, resulting in up to 2.6 million diabetic foot ulcers annually in the U.S. alone. Research published in Diabetes Care in 2006 demonstrated that more than half of all foot ulcers will become infected, thus requiring hospitalization, and 1 in 5 will require an amputation that carries a high risk of mortality. The CDC reports that more than 60% of nontraumatic lower limb amputations occur in people with diabetes, while the International Diabetes Federation estimates that 85% of all diabetes related amputations are preceded by foot ulcers, and a lower limb is lost to diabetes every 30 seconds. Disturbingly, patients hospitalized with diabetes are 28 times more likely to have an amputation than patients without diabetes, according to the Agency for Healthcare Research and Quality (AHRQ). As reported in 2007 in the International Wound Journal, the consequences of major lower extremity amputations in diabetic patients are severe, with an estimated 5-year postoperative survival rate of less than 50%, indicating that mortality associated with diabetic lower extremity amputations exceeds that of most cancers.

The economic burden of diabetic foot ulcers and their complications is enormous. The American Diabetes Association (ADA) estimates that the average cost to heal a diabetic foot ulcer in 2010 was $8,000, while an infected ulcer cost $17,000, and a major lower extremity amputation in a diabetic patient cost $45,000. Since the ADA reports that more than 80,000 amputations are performed each year on diabetic patients in the U.S., the total costs of lower extremity amputations in diabetic patients may exceed $3.6 billion annually. The staggering economic and clinical burdens associated with diabetes and its complications, to include diabetic foot ulcers and lower extremity amputations, make diabetes one of the most pressing and challenging diseases for healthcare systems worldwide.

About dermaPACE dermaPACE, the Company's Pulsed Acoustic Cellular Expression (PACE(R)) technology for use in acute and chronic wound healing, delivers high-energy acoustic pressure waves in the shock wave spectrum to produce compressive and tensile stresses on cells and tissue structures. These mechanical stresses are believed to induce, at both the macro and micro levels, cellular responses crucial to the initiation of the healing cascade. Responses to the mechanical stresses have been shown in studies involving both animals and humans to include microcirculatory improvement, increased perfusion and blood vessel widening (arteriogenesis), the production of angiogenic growth factors, and enhanced new blood vessel formation (angiogenesis). dermaPACE is an Investigational Device in the United States and is limited by Federal law to investigational use only.

About SANUWAVE Health, Inc. SANUWAVE Health, Inc. ( www.sanuwave.com ) is an emerging regenerative medicine company focused on the development and commercialization of noninvasive, biological response activating devices for the repair and regeneration of tissue, musculoskeletal and vascular structures. SANUWAVE's portfolio of products and product candidates activate biologic signaling and angiogenic responses, including new vascularization and microcirculatory improvement, helping to restore the body's normal healing processes and regeneration. SANUWAVE intends to apply its PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE, is CE marked and has Canadian device license approval for the treatment of the skin and subcutaneous soft tissue. In the U.S., dermaPACE is currently under the FDA's Premarket Approval (PMA) review process for the treatment of diabetic foot ulcers. 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(R) device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its Ossatron, Evotron(R) and orthoPACE(R) devices in Europe.

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 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.
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NewsBot · Apr 4, 2013

This Clinical Trial was just registered:
A Comparison of the dermaPACE® (Pulsed Acoustic Cellular Expression) Device in Conjunction With Standard of Care Versus Standard of Care Alone in the Treatment of Diabetic Foot Ulcers

The Sponsor of this study, SANUWAVE, Inc., has developed an investigational device known as the dermaPACE® (Pulsed Acoustic Cellular Expression) device for the possible treatment of diabetic foot ulcers. This device generates acoustic (sound) pressure waves designed to act on the cells in your body to generate proteins that may lead to wound closure. The dermaPACE® device has not been approved for the treatment of diabetic foot ulcers; therefore its use in this study is investigational.

The purpose of the study is to evaluate the ability of the dermaPACE® device to help diabetic foot ulcers heal more quickly. The active study device, the dermaPACE®, will be compared to an inactive look-alike device (called a "Sham") in this study. The sham device will not provide any treatment to your diabetic foot ulcer.
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Admin2 · Aug 19, 2013

Sanuwave May Be Able To Satisfy Investor Appetite For A Diabetic Foot Ulcer Treatment

NewsBot · Mar 25, 2016

Press Release:
SANUWAVE Announces 24-Week Data From Its Pivotal Trials Investigating the Use of dermaPACE for the Treatment of Diabetic Foot Ulcers

SANUWAVE Health, Inc. (OTCBB:SNWV) (www.sanuwave.com), today announced positive combined 24-week data from the Company’s pivotal double-blinded, randomized Phase III, Investigational Device Exemption (IDE) clinical trials comparing dermaPACE? to Sham-control (non-active treatment), when both are combined with the current standard of care for the treatment of diabetic foot ulcers. Diabetic foot ulcers are an area of significant unmet medical need and represent a $2 billion market in the U.S. alone.

The dermaPACE system was evaluated using two studies under an FDA approved IDE. The studies were designed as prospective, randomized, double-blind, parallel-group, sham-controlled, multi-center 24-week studies at 39 centers. A total of 336 subjects were enrolled and treated with either active dermaPACE plus conventional therapy or sham dermaPACE plus conventional therapy (a.k.a. standard of care). Conventional therapy included, but was not limited to, debridement, saline-moistened gauze, and pressure reducing footwear. The objective of the studies was to compare the safety and efficacy of the dermaPACE device to sham-control application. The prospectively defined primary efficacy endpoint for the dermaPACE studies was the incidence of complete wound closure at 12 weeks post-initial application of the dermaPACE system (active or sham). Complete wound closure was defined as complete skin re-epithelialization without drainage or dressing requirements, confirmed over two consecutive visits within 12-weeks. If the wound was considered closed for the first time at the 12 week visit, then the next visit was used to confirm closure. Investigators continued to follow subjects and evaluate wound closure through 24 weeks.

Summary of Key Findings from the Combined Study Data

The first trial showed that the dermaPACE treatment is safe and is well-tolerated by patients. The second, supplemental trial validated these results. The overall percentage of adverse events reported during the studies was comparable between both study groups (p=0.338).
No adverse events were considered definitely related to treatment with the dermaPACE system.
The effectiveness results demonstrate superiority in wound closure of dermaPACE compared to the control at 20 and 24 weeks, as well as, the additional supporting analyses:
dermaPACE demonstrated superior results in wound closure at 20 and 24 weeks compared to the control ( 35.47% vs. 24.39%; p=0.027 at respectively at 20 weeks and 37.79% vs. 26.22%; p=0.023, respectively at 24 weeks)
dermaPACE demonstrated comparable results in wound closure at 12 weeks compared to the control (22.67% vs. 18.29%; p=0.320, respectively)
dermaPACE demonstrated superior results in the overall rate to wound closure compared to the control (p=0.0346) demonstrating that subjects are reaching wound closure at a faster rate when dermaPACE treatment is applied
dermaPACE demonstrated superior results in the reduction in area (cm2) of the wound when compared to the control at 24 weeks (1.92cm2 versus 0.16cm2; p=0.047, respectively).
dermaPACE demonstrated superior results in the prevention of wound expansion (≥ 10% increase in wound size) over the course of the study at 12 weeks (18.0% versus 31.1%; p=0.005, respectively)
dermaPACE demonstrated a trend toward superiority in the prevention of wound expansion (≥ 10% increase in wound size) over the course of the study at 24 weeks (25.6% versus 34.2%; p=0.086, respectively)
dermaPACE demonstrated a lower overall rate of full target ulcer amputations compared to the control (2.3% vs. 3.0%; p-value=0.745, respectively)
Clinical Studies Results

I. Primary Efficacy Analysis at 12 and 24 Weeks

In both studies, the primary endpoint was to assess the effectiveness (incidence of complete wound closure) of the dermaPACE and sham-control groups 12 weeks post-initial application. While superiority was not demonstrated at 12 weeks, superiority was demonstrated at 20 weeks and 24 weeks post-initial application. While not statistically significant, the percentage of dermaPACE subjects with wound closure is higher at 12 weeks compared to the control. Although the primary endpoint was not met, these results do demonstrate a reasonable assurance of effectiveness at the later time points when using dermaPACE system.

Study 2 does not demonstrate superiority at these timepoints (p=0.339 and p=0.254, respectively), the overall population indicates that the device does offer a benefit to patients at a very low risk. The wound closure rate for dermaPACE at 24 weeks in Study 2 was 35.4% compared to 26.2% in the sham control.

On a combined basis, at the 12 week endpoint a total of 39 out of 172 (22.7%) of dermaPACE patients had complete wound closure, compared to 30 out of 164 (18.3%) in the control group. There was no statistically significant difference in wound closure at the 12 week follow up between the dermaPACE and control group; however, in subsequent visits a trend towards significance was shown resulting in a significant difference by the 20 week endpoint that was maintained through the end of the study. At the 24 week endpoint, the rate of wound closure in the dermaPACE cohort was 37.8% compared to 26.2% for the control group, resulting in a p-value of 0.023

In Time-to-Closure analysis on the combined study data, the proportion of patients with wound closure indicate a statistically significant difference between the dermaPACE and the control group in the proportion of subjects with the target-ulcer not closed over the course of the study (p-value=0.0346). Approximately 25% of dermaPACE subjects reached wound closure per the study definition by day 84 (week 12). The same percentage in the control group (25%) did not reach wound closure until day 112 (week 16). These data indicate that in addition to the proportion of subjects reaching wound closure being higher in the dermaPACE group, subjects are also reaching wound closure at a faster rate when dermaPACE is applied.

II. Additional Efficacy Analyses

A number of additional analyses were conducted on the combined study data to support the conclusion that dermaPACE provides a reasonable assurance of safety and effectiveness when used to treat diabetic foot ulcers.

An analysis was performed on subjects who had a 50% wound area reduction maintained at two consecutive visits. At 12 and 24 weeks, the dermaPACE group has a higher percentage of subjects with a 50% wound reduction compared to control (p=0.0554 and p=0.0899, respectively). Both time points demonstrate a trend toward statistical significance.

The mean wound area reduction for both cohorts was analyzed and the mean wound reduction for dermaPACE subjects at 24 weeks was 1.92cm2 compared to 0.16cm2 in the control group. There was a statistically significant difference between the wound area reductions of the two cohorts from the 6 week follow up visit through the end of the study. Because means can be influenced by outliers in the data, the median wound reduction was also reported and favored dermaPACE system.

An analysis on the number of patients reporting an increase in wound size demonstrates that a significantly greater proportion of sham control subjects had an increase of at least 10% in their wound area. This indicates that not only does dermaPACE aid in wound healing (decrease in wound size), dermaPACE also may prevent wounds from getting worse (increasing in wound size). The differences are statistically significant in favor of dermaPACE with the exception of Week 2 and Week 24 which are both trending towards significance.

The success results at 12 and 24 weeks have been stratified by demographic characteristics to determine if any notable differences were identified when each characteristic is compared.

At 12 weeks, the only statistically significant difference observed between the two groups was in the subjects who were greater than or equal to 70 inches in height. The percentage of dermaPACE subject who had complete wound closure was 30.0% compared to 14.1% in the control group.
At 24 weeks, several sub-populations demonstrated a statistically higher percentage of wound closure in dermaPACE subjects compared to the control subjects. Subjects with age less than 65 years, BMI less than 32, height greater than or equal to 70 inches, and male subjects all had success rates statistically significantly higher than the control group (p-value = ≤ 0.050).
III. Safety

The primary safety endpoint of the overall rate of adverse events throughout the 24 week study was not statistically different between dermaPACE and Sham-control. The total number of serious adverse events related to application site infections was reduced in dermaPACE and no issues regarding the tolerability of dermaPACE treatment was shown throughout the application, treatment and follow-up periods of the study.

In addition to a lower rate of serious adverse events, the dermaPACE cohort exhibited a lower rate of target ulcer recurrence and amputations. The recurrence rate for dermaPACE patients was 7.7% compared to 11.6% in the control group (p-value=0.490). The percentage of patients that had to undergo amputation of the target ulcer was lower in dermaPACE as well (2.3% vs. 3.0%, p-value= 0.745, respectively).

Kevin Richardson, Chairman and CEO of SANUWAVE Health, Inc. stated, “The dermaPACE device demonstrates a positive benefit-risk ratio based on the outcome of the two clinical studies performed. A significantly greater percentage of dermaPACE subjects were considered a success at 20 weeks and out to final follow-up at 24 weeks. While, the data did not demonstrate superiority at 12 weeks, a trend is clearly demonstrated toward superior effectiveness when using dermaPACE to treat diabetic foot ulcers.”

Conclusions

Compared to the control, the dermaPACE data demonstrates a greater reduction in wound size and a lower number of subjects with an increase in wound size. As such, dermaPACE could be a factor in reducing the risks of infections, amputation and comorbidities associated with diabetic foot ulcers, improving the patient’s quality of life. In addition, the adverse events associated with the dermaPACE treatment were comparable to those seen in the control group in both incidence and type. These events are most likely a result of the diabetes or the foot ulcer rather than the actual dermaPACE device treatment.

It is important to note that a key benefit of the dermaPACE device is that it can be used in conjunction with standard of care or other treatment options as an initial alternative to more invasive, higher risk devices. If the physician feels that additional modes of treatment are needed in addition to dermaPACE, all other previously available treatment options are still available to the patient. In essence, the dermaPACE device provides an additional treatment option for clinicians to utilize, while not limiting any future or concurrent treatment options.

With CE Marking for dermaPACE in the European Union, and distribution approval in South Korea, Canada, Australia, New Zealand, and various other countries, dermaPACE is becoming a desired mode of treatment for DFUs on a growing global basis. Doctors and patients have been pleased with the accelerated wound area reduction and wound closure seen when using the device. The ease of treatment delivery is a key benefit for treating clinicians and the tolerability of the treatment is a welcome element for patients. The approval of dermaPACE by the FDA will improve our distribution efforts in these countries and assist with approval into new countries.

Next Steps

SANUWAVE has submitted a Pre-Submission package to FDA, detailing the results presented above. We expect to meet face-to-face with the FDA review team in late-April or early-May. The goal of this meeting is to work interactively with FDA to bring dermaPACE to market in the most expeditious possible manner. Attending this meeting will be SANUWAVE’s regulatory consultants and Musculoskeletal Clinical Regulatory Advisors (MCRA). MCRA is the world leading regulatory advisor to the neuro-musculoskeletal industry on U.S. FDA related activities. Their expertise in helping companies gain FDA approval for products will benefit the Company greatly in representing dermaPACE to FDA. The Company anticipates a final product submission to FDA in Q2 2016.
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NewsBot · Aug 22, 2018

This clinical trial was just registered:
The Effects of High Energy Acoustic Shock Wave Therapy on Local Skin Perfusion and DFUs

This is an observational, single-arm study. This clinical study will be conducted at up to 4 sites with a total of 10 subjects per site. All subjects will receive standard of care treatment which includes DFU treatments with the dermaPACE device.
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dermaPACE for diabetic foot ulcers

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Pravibismane for diabetic foot infections

Homeopathy for Diabetic Foot Ulcers

Diabetic Foot Influencers on Twitter

Low Plasma Arginine among Patients with Diabetic Foot Ulcer

Epalrestat is effective in treating diabetic foot infection

Targeted exercises for the diabetic foot

Pranic Healing for Diabetic Foot Ulcer Management

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dermaPACE for diabetic foot ulcers

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Admin2 Administrator Staff Member

NewsBot The Admin that posts the news.

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Pravibismane for diabetic foot infections

Homeopathy for Diabetic Foot Ulcers

Diabetic Foot Influencers on Twitter

Low Plasma Arginine among Patients with Diabetic Foot Ulcer

Epalrestat is effective in treating diabetic foot infection

Targeted exercises for the diabetic foot

Pranic Healing for Diabetic Foot Ulcer Management

Share This Page

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