SANUWAVE Health, Inc., (OTC BB: SNWV) (www.sanuwave.com),
an emerging medical technology company focused on the development and
commercialization of non-invasive, biological response activating
devices in the regenerative medicine area, today announced that a
journal article titled Extracorporeal Shock Wave Therapy for Nonunion
of the Tibia, was published in the March 2010 issue of the Journal
of Orthopedic Trauma. Based on the results of the study, the authors
suggest that non-invasive Extracorporeal Shock Wave Technology (ESWT)
applied with SANUWAVE’s Ossatron® device with one treatment session of
4000 pulses followed by fracture immobilization resulted in an 80% rate
of healing of the nonunion bone fractures (incomplete fracture healing)
as assessed by both clinical and radiographic means.
The authors of the study, Elster E., Stojadinovic A., Forsberg J.,
Shawen S., Andersen R. and Schaden W., represent the National Naval
Medical Center, Naval Medical Research Center, Walter Reed Army Medical
Center and AUVA Trauma Center in Vienna, Austria. The journal article
detailed a 6-year study that included 172 patients undergoing treatment
for tibia nonunion utilizing SANUWAVE’s Ossatron® device. The majority
of patients referred to the study for tibia nonunion were resistant or
unresponsive to one or more surgical treatments. Median time to healing
from last orthopaedic operation was 14 months with a mean follow-up of
nearly 16 months. The average time to healing after ESWT was 4.8 months.
The authors stated that although the precise mechanism of targeted
physical energy to produce the desired biologic effect of bone healing
is not completely understood, migration and differentiation of
mesenchymal stem cells (multipoint stem cells that can differentiate
into a variety of cell types), and promotion of angiogenesis are thought
to contribute increased bone mass and strength.
SANUWAVE expects to introduce a new commercial device to European
markets called the orthoPACE™ that is capable of treating in an
equivalent energy range utilized in this study. Scheduled to be launched
during the second quarter of 2010, the orthoPACE™ has a compact,
portable design and allows for treatments to be performed by a single
operator in both the hospital and office setting. The orthoPACE™
replaces SANUWAVE’s Ossatron®, the 800 lb. legacy device that was used
in this study. The orthoPACE™ will be indicated for a wide range of
orthopedic, sports medicine and trauma indications including acute and
nonunion fracture treatment.