SANUWAVE Health, Inc., (OTC BB: SNWV) (www.sanuwave.com),
an emerging medical technology company focused on regenerative medicine,
announced that a European scientific study reporting the successful
treatment of severe burns using the dermaPACE® device has
been published by BURNS, the Journal of the International
Society for Burn Injuries.
“The dermaPACE® device fulfills a need in the
burn treatment community. It is a new, non-invasive device to
successfully treat burns safely and cost effectively, producing
excellent results and in many cases may preclude additional patient
trauma due to surgery and grafting.”
The paper titled, Extracorporeal Shock Waves, a New Non-Surgical
Method to Treat Severe Burns, appeared as an e-publication ahead of
print in BURNS (www.burnsjournal.com),
and detailed the successful use of PACE™ protocols with the dermaPACE®
device for the treatment of severe burns, including deep partial and
full thickness burns. Between January and May 2009, patients with second
and third degree burns received dermaPACE® treatments of 500
impulses on days 3 and 5 after their injury. Burns healed uneventfully
within 15 days for 12 out of 15 patients (80%), 2 patients required
grafting and 1 patient was lost to follow up. No side effects were
observed.
The study involved fifteen deep-partial and full-thickness burns
initially diagnosed as deep enough to require surgical treatment
according to the article’s authors. However, these burn wounds healed
after non-invasive PACE™ treatment, and re-epithelialization was
achieved without surgery in 80% of cases. After PACE™ treatment, burns
had a significant increase in acute blood flow to the burn area as
measured with Laser Doppler Imaging. Significantly, patients healed with
PACE™ did not experience scarring typical of these injuries, and none of
the wounds became infected. In addition, only 3 in 15 patients reported
any pain at all during the treatment, and they rated the pain level as
minimal.
In response to positive European clinical results and the need for
non-invasive advanced burn care modalities, SANUWAVE expects to initiate
a Phase II, Investigational Device Exemption (IDE) study in the U.S. in
2010 using the dermaPACE® for the treatment of burns.
Juan P. Barret, M.D., Ph.D., Head of the Department of Plastic,
Aesthetic and Reconstructive Surgery and Director of the Burn Center at
Vall d’Hebron University Hospital in Barcelona, Spain, one of the
authors, said, “The dermaPACE® device fulfills a need in the
burn treatment community. It is a new, non-invasive device to
successfully treat burns safely and cost effectively, producing
excellent results and in many cases may preclude additional patient
trauma due to surgery and grafting.”