SANUWAVE Health Reports 2009 Third Quarter Results

Posted on: Mon, 16 Nov 2009 07:00:00 EST


Symbols: SNWV
ALPHARETTA, Ga., Nov 16, 2009 (BUSINESS WIRE) --
SNWV | Quote | Chart | News | PowerRating -- SANUWAVE Health, Inc., (OTC BB: SNWV | Quote | Chart | News | PowerRating) (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, reports its achievements and
financial results for the three and nine months ended September 30, 2009.

Christopher M. Cashman, President and CEO of SANUWAVE said, "We are
pleased to update our shareholders on a regular basis, and are reporting
on our achievements for the third quarter. Included in this quarterly
review are our business achievements and financial results. It is
important to note that our efforts are on the continued research and
development of dermaPACE(TM), our lead product in our technology platform."

"Our initial focus is on the $10 billion global wound care opportunity
for dermaPACE(TM), including the diabetic foot ulcer market, for which we
are in the midst of an Investigational Device Exemption ("IDE") wound
care study. SANUWAVE is also pursuing with the FDA alternative
regulatory pathways to Class III PMA routes which could provide for the
clearance of a PACE(TM) device to be marketed for applicable orthopedic and
plastic/cosmetic conditions that would benefit from improved circulation
into the localized site. We expect to finalize next steps for a
submission package by the end of 2009."

He continued, "We have a broad product development pipeline that
includes degenerative disease and non-healing injuries in the
orthopedics, spine/neuro, plastic/aesthetics and cardiac markets. Our
preclinical studies in each of these areas demonstrate the potential use
of our technology for multiple platforms."

Corporate and Clinical Updates for the Third Quarter:

--
Surpassed 75% of expected final patient enrollment in our dermaPACE(TM)
(IDE) wound care study on diabetic foot ulcers.

--
Increased the number of active sites for the IDE clinical trial
evaluating dermaPACE(TM) to 22, with 20 in the United States and two
international sites in the United Kingdom and Germany. Southern
Arizona VA Medical Center in Tucson became the newest site in this
randomized, double blinded, placebo controlled study.

--
Completed a reverse merger with a subsidiary of Rub Music Enterprises,
Inc. on September 25, 2009. The Company's name was changed to SANUWAVE
Health, Inc. on November 5, 2009 and we received a new stock symbol
("SNWV"), which became effective on November 12, 2009.

--
Subsequent to the end of the quarter, Dr. Myron Spector, PhD,
Professor of Orthopedic Surgery (Biomaterials) at Harvard Medical
School and Director of Orthopedic Research at Brigham and Women's
Hospital, presented the results of preclinical research that support
the proposition that PACE(TM) shows promise in stimulating autogenous
sources of progenitor stem cells for harvest and re-transplantation in
bone tissue engineering. Dr. Spector was an invited guest speaker at
the Bone-Tec Congress in Hannover, Germany on October 9, 2009. The
procedure could have meaningful use in clinical applications whereby a
patient's own osteoprogenitor cells could be harvested and reimplanted
for procedures such as bone fusion, joint reconstruction and cartilage
repair.

--
Also subsequent to the end of the third quarter, Drs. Reichenberger,
Germann, Roth, Meirer and Engel published in the October 7, 2009 Annals
of Plastic Surgery, Volume 63 - Issue 4, "Preoperative Shock Wave
Therapy Reduces Ischemic Necrosis in an Epigastric Skin Flap Model"
demonstrating the use of PACE(TM) technology as a non-invasive technique
to precondition flap tissue in a rat epigastric skin flap model. This
study indicates that preoperative extracorporeal shock wave therapy
may enhance skin flap survival in a rodent model.

Financial Results for the Third Quarter

SANUWAVE's financial results for the third quarter of 2009 reflect the
Company's ongoing research and development of PACE(TM) technology for the
dermaPACE(TM) IDE wound care study and development work for orthopedic and
cosmetic uses. For the three months ended September 30, 2009, the
Company reported a loss from continuing operations of $2.7 million, or
($0.23) per diluted share, compared to a loss from continuing operations
of $2.9 million, or ($0.26) per diluted share, for the same period in
2008. The loss from continuing operations includes: the non-cash
compensation costs included in general and administrative expenses for
stock compensation of $0.3 million for the three months ended September
30, 2009, compared to $0.1 million for the same period in 2008, due to
new grants of options and restricted stock to management and directors
of the Company in the three months ended September 30, 2009; the
non-cash costs for depreciation and amortization of $0.1 million for the
three months ended September 30, 2009, compared to $0.1 million for the
same period in 2008; and the costs of accrued deferred interest on notes
payable to related parties of $0.2 million for the three months ended
September 2009, compared to $0.1 million for the same period in 2008. In
addition, included in general and administrative expenses for the three
months ended September 30, 2009, are legal, accounting and other
expenses of $0.3 million related to the reverse merger.

For the three months ended September 30, 2009, the Company reported a
net loss of $2.7 million, or ($0.23) per diluted share, compared to a
net loss of $2.4 million, or ($0.21) per diluted share, for the same
period in 2008. The net loss includes income from discontinued
operations of $0 and $0.6 million for the three months ended September
30, 2009 and 2008, respectively, related primarily to the veterinary
product line sold in June, 2009 for $3.5 million.

For the nine months ended September 30, 2009, the Company reported a net
loss of $3.5 million, or ($0.30) per diluted share, compared to a net
loss of $7.8 million, or ($0.73) per diluted share, for the same period
in 2008. The net loss for the nine months ended September, 2009 includes
the gain on the sale of the veterinary product line in June, 2009 of
$2.5 million.

The Company ended the third quarter of 2009 with $3.3 million of cash
and cash equivalents compared with $0.5 million as of December 31, 2008.

Mr. Cashman concluded, "SANUWAVE has a proven technology, with superior
efficacy and cost profile, multiple near-term milestones that we believe
will create value for our shareholders, a broad patent estate and
protection, and a significant product development pipeline addressing
global markets. With a strong team in place, we believe there are a
number of significant milestones ahead of us that will enable the
company to enhance shareholder value. We appreciate the support of our
new shareholders and look forward to reporting on our future
achievements."

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(TM)) technology in
wound healing, orthopedic/spine, plastic/cosmetic and cardiac
conditions. Its lead product candidate for the global wound care market,
dermaPACE(TM), 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(R) device
and in the stimulation of bone and chronic tendonitis regeneration in
the musculoskeletal environment through the utilization of its Ossatron(R)
and Evotron(R) devices in Europe. For more information about the
dermaPACE(TM) 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.

(FINANCIAL TABLES FOLLOW)

SANUWAVE HEALTH, INC. ANDSUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
September 30, December 31,
2009 2008
ASSETS
CURRENTASSETS
Cash and cash equivalents $ 3,297,436 $ 543,626
Accounts receivable - trade, net of allowance for doubtful 87,384 52,414
accounts of $26,363 in 2009 and $64,490 in 2008
Inventory 584,572 684,750
Prepaid expenses 56,364 106,617
Due from Pulse Veterinary Technologies, LLC 167,990 -
Current assets related to discontinued operations 168,509 1,285,017
TOTALCURRENTASSETS 4,362,255 2,672,424
PROPERTYANDEQUIPMENT, at cost, less accumulated depreciation 136,891 279,791
OTHERASSETS 63,261 81,017
INTANGIBLEASSETS, at cost, less accumulated amortization 2,223,984 2,454,051
NON-CURRENTASSETS RELATEDTODISCONTINUEDOPERATIONS 924,971 1,011,734
TOTALASSETS $ 7,711,362 $ 6,499,017
LIABILITIES
CURRENTLIABILITIES
Accounts payable $ 1,233,942 $ 975,811
Payroll and related 511,770 820,397
Accrued expenses 350,744 448,242
Liabilities related to discontinued operations 655,761 845,593
TOTALCURRENTLIABILITIES 2,752,217 3,090,043
NOTESPAYABLE, RELATEDPARTIES 8,659,554 6,006,815
TOTALLIABILITIES 11,411,771 9,096,858
COMMITMENTS ANDCONTINGENCIES
STOCKHOLDERS' EQUITY(DEFICIT)
COMMONSTOCK 12,510 11,500
ADDITIONALPAID-INCAPITAL 32,248,865 30,094,546
ACCUMULATEDOTHERCOMPREHENSIVELOSS (4,081 ) (196,646 )
RETAINEDDEFICIT (35,957,703 ) (32,507,241 )
TOTALSTOCKHOLDERS' EQUITY(DEFICIT) (3,700,409 ) (2,597,841 )
TOTALLIABILITIESANDSTOCKHOLDERS' EQUITY(DEFICIT) $ 7,711,362 $ 6,499,017
SANUWAVEHEALTH, INC. ANDSUBSIDIARIES
CONDENSEDCONSOLIDATEDSTATEMENTSOFOPERATIONS AND COMPREHENSIVE
LOSS
(UNAUDITED)
Three Months Ended Three Months Ended Nine Months Ended Nine Months Ended
September 30, September 30, September 30, September 30,
2009 2008 2009 2008
REVENUES $ 134,771 $ 167,423 $ 538,818 $ 862,651
COSTOFREVENUES 30,753 60,213 129,416 281,948
GROSSPROFIT 104,018 107,210 409,402 580,703
OPERATINGEXPENSES
Research and development 1,063,876 865,518 2,686,160 2,396,185
General and administrative 1,530,282 1,935,750 3,433,448 6,027,089
Depreciation 46,636 70,031 150,482 193,602
Amortization 76,689 76,689 230,067 230,067
TOTALOPERATINGEXPENSES 2,717,483 2,947,988 6,500,157 8,846,943
OPERATINGLOSS (2,613,465 ) (2,840,778 ) (6,090,755 ) (8,266,240 )
OTHERINCOME(EXPENSE)
Gain/(loss) on sale of assets 9,142 - (4,509 ) -
Transitional services provided to Pulse Veterinary Technologies, 102,500 - 136,250 -
LLC
Interest expense (188,278 ) (72,552 ) (517,354 ) (213,042 )
Loss on foreign currency exchange (6,654 ) (4,129 ) (44,428 ) (29,135 )
TOTALOTHERINCOME(EXPENSE) (83,290 ) (76,681 ) (430,041 ) (242,177 )
LOSSFROMCONTINUINGOPERATIONSBEFOREINCOMETAXES (2,696,755 ) (2,917,459 ) (6,520,796 ) (8,508,417 )
INCOMETAXEXPENSE - - - -
LOSSFROMCONTINUINGOPERATIONS (2,696,755 ) (2,917,459 ) (6,520,796 ) (8,508,417 )
DISCONTINUEDOPERATIONS
Income from discontinued operations, net of tax - 565,534 581,306 684,662
Gain/(loss) on sale of veterinary division, net of tax (3,245 ) - 2,489,028 -
NETINCOME (LOSS)FROMDISCONTINUEDOPERATIONS (3,245 ) 565,534 3,070,334 684,662
NETLOSS (2,700,000 ) (2,351,925 ) (3,450,462 ) (7,823,755 )
OTHERCOMPREHENSIVE INCOME(LOSS), net of tax
Foreign currency translation adjustments 12,031 (135,365 ) (33,671 ) (52,363 )
TOTALCOMPREHENSIVELOSS $ (2,687,969 ) $ (2,487,290 ) $ (3,484,133 ) $ (7,876,118 )
EARNINGS(LOSS)PERSHARE:
Loss from continuing operations - basic $ (0.23 ) $ (0.26 ) $ (0.56 ) $ (0.79 )
Loss from continuing operations - diluted $ (0.23 ) $ (0.26 ) $ (0.56 ) $ (0.79 )
Income (loss) from discontinued operations - basic $ (0.00 ) $ 0.05 $ 0.26 $ 0.06
Income (loss) from discontinued operations - diluted $ (0.00 ) $ 0.05 $ 0.26 $ 0.06
Net loss - basic $ (0.23 ) $ (0.21 ) $ (0.30 ) $ (0.73 )
Net loss - diluted $ (0.23 ) $ (0.21 ) $ (0.30 ) $ (0.73 )
Weighted average shares outstanding - basic 11,836,552 11,383,932 11,612,184 10,798,162
Weighted average shares outstanding - diluted 11,836,552 11,383,932 11,612,184 10,798,162

SOURCE: SANUWAVE Health, Inc.


SANUWAVE Health, Inc.
Barry Jenkins, CFO, 678-578-0103
Emily Browning, Marketing Manager, 678-578-0103
OR
Porter, LeVay & Rose, Inc.
Marlon Nurse, VP, Investor Relations, 212-564-4700
Bill Gordon, SVP, Media Relations, 212-564-4700

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