ALPHARETTA, Ga.–(BUSINESS
WIRE)–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 the publication of peer-reviewed, preclinical data that demonstrate
the ability of the Companys extracorporeal shock wave technology (ESWT) to
substantially stimulate proliferation of periosteal progenitor/adult stem cells
within the body and significantly increase the quantity and quality of adult
stem cells that can be harvested from the cambium layer (the inner osteogenic
layer of the periosteum) for select tissue engineering and regenerative
medicine applications.

The authors demonstrated that ESWT effectively proliferates
adult stem cells within the periosteum of femurs and tibias in a rodent model,
which the authors suggest could then be more efficiently harvested and
transplanted for orthopaedic applications, such as fracture or joint repair and
human tissue engineering applications. The publication, titled “Extracorporeal
Shock Wave-Induced Proliferation of Periosteal Cells,” appears in a recent
edition of the Journal of Orthopaedic Research.

An abstract of the publication can be accessed online at the
Journal of Orthopaedic Research website: http://onlinelibrary.wiley.com/doi/10.1002/jor.21346/abstract.

Summary of Key Study Findings

• In the tibia, four days after a single treatment, ESWT resulted in a six-fold
  increase in the number of adult stem cells within the cambium layer and an
  eight-fold increase in cambium layer thickness. In the femur, also at four days
  following treatment, ESWT resulted in a three-fold increase in the number of
  adult stem cells and nearly a five-fold increase in the thickness of the
  cambium layer.
• The ESWT energy levels used to stimulate the proliferation of
  adult stems cell did not damage surrounding tissues.
• The elevated presence of certain proteins at the treatment
  site suggests that ESWT promotes rapid vascularization of bone.
• ESWT has the potential to be a noninvasive, fast, safe and
  relatively inexpensive way to stimulate periosteal adult stem cell
  proliferation within the human body that may be harvested for select tissue
  engineering and regenerative medicine applications.

Led by Myron Spector, M.D., a professor and researcher at
Harvard-MIT Division of Health Sciences and Technology, the authors concluded,
“This study successfully demonstrated the use of ESWT as a non-invasive and
rapid way of stimulating the periosteal cambium cells to proliferate. The
advantage of the proliferated and thickened periosteal layer is 2-fold.
Firstly, the proliferated cells provide more cells for surgical or tissue
engineering strategies. Secondly, the thickened layer reduces the technical
difficulty in harvesting the periosteal cells for use, which increases the probability
of successful cambium layer, and not just fibrous layer, tissue harvest. Our
model proposes a relatively inexpensive, non-invasive, and safe way to
stimulate periosteal cell proliferation.”

According to the study authors, “ESWT stimulated periosteal
cells to differentiate down an osteogenic (bone growth) pathway.” Furthermore,
“For the large majority of samples, the (outer) fibrous layer (of the
periosteum) was structurally unchanged in the ESWT groups when compared with
controls. This provides a suturable layer for surgical use, which may be
advantageous over mesenchymal stem cells (MSCs) or other cell sources, as the
fibrous sheet can act as a delivery vehicle and can support the (adult stem)
cells. Future studies are needed to investigate the suitability of the
proliferated cells for bone – and cartilage – tissue engineering and
regenerative medicine strategies.”

Christopher M. Cashman, President and CEO of SANUWAVE, said,
“This exciting, early stage research underscores the potential of our
proprietary ESWT platform, defined as Pulsed Acoustic Cellular Expression (PACE®)
technology, as an adult stem cell proliferation and differentiation modality.
Practical applications in tissue engineering and regenerative medicine may
include, among other uses, fracture healing and autograft harvesting for bone
and cartilage regeneration, which are very large markets. PACE treatment has
the distinct clinical advantage of being noninvasive, safe and more cost
effective than current adult stem cell proliferation, harvesting and
differentiation methods. Additionally, the findings of this study build upon an
already large body of clinical evidence that demonstrates the proliferative and
proangiogenic (new blood vessel growth) effects of PACE technology.”

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. SANUWAVEs portfolio of
products and product candidates activate biologic signaling and angiogenic
responses, including new vascularization and microcirculatory improvement,
helping to restore the bodys 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 for
treatment of the skin and subcutaneous soft tissue and recently completed its
highly positive pivotal Phase III, Investigational Device Exemption (IDE)
clinical trial in the U.S. for the treatment of diabetic foot ulcers. SANUWAVE
researches, designs, manufactures, markets and services its products worldwide,
and believes it has demonstrated that this 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.

Posted by Sean Fenske, Editor-in-Chief, MDT