SANUWAVE Health Completes Enrollment in dermaPACE Phase III Pivotal IDE Clinical Trial for the Treatment of Diabetic Foot Ulcers

207 Patients Enrolled At 24 Sites
ALPHARETTA, Ga.--(Business Wire)--
SANUWAVE Health, Inc., (OTC BB: SNWV), 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 patient enrollment was completed in March in its dermaPACE Phase III
pivotal, randomized, double-blinded, sham controlled, multicenter clinical trial
comparing its Pulsed Acoustic Cellular Expression (PACE) technology, utilizing
the dermaPACE tissue regeneration device, to sham control for the treatment of
diabetic foot ulcers (DFU).

The primary study goal is to establish superiority in diabetic foot ulcer
healing rates using the dermaPACE treatment compared to sham control, when both
are combined with the current standard of care. The standard of care includes
wet-to-dry dressings, the most widely used primary dressing material in the
United States, and offloading with a walking boot.

A total of 207 patients have entered the dermaPACE study at 24 sites, including
Boston Medical Center, Phoenix VA, Northwestern University in Chicago, VA Long
Beach, California, The Ohio State University Medical Center in Columbus, King`s
College Hospital in London, Emory Orthopedics and Spine Center in Atlanta,
Calvary Hospital in New York, and the North American Center for Limb
Preservation in New Haven, Connecticut. The principal investigators in the study
represent the multidisciplinary nature of treating chronic wounds, including
specialties such as vascular surgery, plastic surgery, podiatry and
endocrinology.

The study patients must be followed a total of 24 weeks. The study`s primary
endpoint, wound closure, is defined as "successful" if the skin is
reepithelialized without drainage or dressing requirements confirmed at two
consecutive study visits. Final study data including time to closure, total
wound size reduction, long-term safety, and study subject assessments is
expected to be available by the fourth quarter of this year. The Company plans
to announce a summary of the top-line data immediately following validation of
study results and statistical analysis. In addition, the Company is finalizing
its regulatory submission plan with the FDA and will provide further information
when the plan is established.

Vickie R. Driver, DPM, a principal investigator in the dermaPACE trial and
Associate Professor of Surgery at Boston University School of Medicine said,
"Completing patient enrollment for the dermaPACE trial is a major accomplishment
for SANUWAVE and all the participating study sites. Diabetic foot ulcer trials
can be especially difficult from a patient enrollment standpoint because
diabetic patients are often very sick and cannot participate in a trial. It is
not often that a company in the chronic wound market undertakes such an
ambitious enrollment target in this patient population, let alone achieves it.
As an investigator in this trial, I am encouraged by the high enrollment number,
as the dermaPACE holds promise to significantly improve our traditional outcomes
for closing diabetic foot ulcers and preserving limbs. dermaPACE is a novel,
advanced wound healing modality - yet it is also easy to administer and
adaptable to almost any clinical care environment. I look forward to seeing the
final data as soon as it is available."

Christopher M. Cashman, President and CEO of SANUWAVE, said, "I am encouraged
and deeply grateful for the dedication and passionate commitment of our study
sites. Enrollment in 2010 has been strong, and we reached our target patient
enrollment earlier than expected in the first quarter of this year. This
significant milestone will allow us to unblind and analyze the data and report
on it, with our expectation to file our regulatory submission in 2010. We will
continue to be aggressive with our timelines, as the medical need is
well-documented, urgent and growing. In the U.S. alone, there are up to 3
million foot ulcers in any given year. And with 27 million diabetics in the U.S.
and 54 million that are pre-diabetic, this disease state is only getting worse.
Unfortunately, the occurrence of diabetes onset is also on the rise in many
other countries, making our mission one of global importance. The United States
diabetic foot ulcer market is estimated to be approximately a $2 billion portion
of the estimated $10 billion global advanced wound care market."

Mr. Cashman continued, "Foot complications are the most frequent reason for
hospitalization in patients with diabetes, accounting for up to 25 percent of
all diabetic admissions in the U.S. This places a tremendous burden on available
healthcare resources and seriously diminishes quality of life for patients and
their families. Early detection and appropriate treatment of diabetic foot
ulcers may eliminate the vast majority of amputations. As shown in our complete
body of clinical work, dermaPACE has been able to efficiently promote wound
closure, and to provide treatment in a convenient, flexible and cost-effective
manner that encourages both the caregiver and the patient to adopt dermaPACE
into their standard of care. Our high enrollment of 207 patients in the
dermaPACE multicenter diabetic foot ulcer trial is another positive indicator
that dermaPACE treatment can be successfully incorporated into the clinical care
system."

Study Design

The objective of the dermaPACE clinical trial is to compare the safety and
effectiveness of the dermaPACE device to sham control, when administered in
conjunction with the standard of care, in the treatment of diabetic foot ulcers.
It is a randomized, double-blind, sham controlled, multicenter, 26-week,
parallel assignment study design with a primary endpoint of diabetic foot ulcer
closure at 12 weeks following the first treatment application. Secondary
endpoints include time to closure, reduction in total wound surface area and
volume, long-term safety, and skin appearance and pain assessments.

About PACE

PACE, defined as Pulsed Acoustic Cellular Expression, delivers high-energy
acoustic pressure waves to produce compressive and tensile stresses on cells and
tissue structures to promote a positive inflammatory response 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 the inflammatory and proliferation
phases of healing and subsequently returns a chronic condition to an acute
condition to help the body`s own healing response to re-initiate.

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (www.sanuwave.com) is an emerging medical technology
company focused on the development and commercialization of non-invasive,
biological response activating devices in the regenerative medicine area 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 Pulsed Acoustic
Cellular Expression (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 is currently involved in an FDA-approved
Investigational Device Exemption 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 already 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 and Evotron devices in Europe. For more information
about the dermaPACE diabetic foot ulcer trial, please visit www.dermapace.com.

Safe Harbor Statement

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.

SANUWAVE Health, Inc.
Barry Jenkins, 678-578-0103
CFO
or
Bernie Laurel, 678-578-0103
VP of Sales and Marketing
or
Porter, LeVay & Rose, Inc.
Marlon Nurse, 212-564-4700
VP, Investor Relations
or
Bill Gordon, 212-564-4700
SVP, Media Relations

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