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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
Quote:
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.
dermaPACE for diabetic foot ulcers
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