SANUWAVE Health, Inc. (OTCBB: SNWV) 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. 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 PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. The Company has reported its financial results for the three months ended March 31, 2012 and provided a business update.
Christopher M. Cashman, President and CEO of SANUWAVE, stated,
"As recently announced, we have been granted conditional approval by the U.S. Food and Drug Administration (FDA) of our Investigational Device Exemption (IDE) Supplement for an additional clinical trial utilizing our dermaPACE® device in the treatment of diabetic foot ulcers. We believe the clinical trial could be completed and submitted in support of a Premarket Approval (PMA) application for dermaPACE in as early as 20 months from trial initiation, assuming such data to be collected meets the agreed upon statistical and clinical plan of success. The Company has already identified clinical study sites and is in the process of qualifying them for participation. Patient enrollment is expected to begin once Institutional Review Board (IRB) approvals and appropriate funding to conduct the study are in place, which is forecasted to occur as early as the third quarter of this year."
He continued,
"We continue to make every effort to lower our cash burn to the maximum extent to which we do not affect the value of the business, our ability to raise funds or pursue strategic options, or our capability to start up and conduct our next dermaPACE study to treat diabetic foot ulcers. As previously announced, we have retained the services of Canaccord Genuity Inc., a leading investment bank, to help us explore capital fund raising and/or strategic options for SANUWAVE to fund the Company so we can start this clinical work.
The FDA’s conditional approval of the IDE Supplement is a highly positive development in the approval process of dermaPACE for the U.S. market. The planned trial provides a scientifically robust, yet potentially more expeditious pathway to validation of dermaPACE’s safety and efficacy and subsequent FDA approval. Our focus remains the same, which is to achieve FDA approval as soon as possible in order to make dermaPACE available to the millions of U.S. patients who suffer from debilitating, recalcitrant diabetic foot ulcers."
Financial highlights for the 2012 first quarter include (all comparisons are with the 2011 first quarter):
- Gross profit increased by $8,313, or 5%, to $166,768. Gross profit as a percentage of revenues increased to 70%, up from 63%.
- Total operating expenses decreased by $291,174, or 13%. The Company will recognize the full extent of cost saving measures implemented in Q1-2012, including headcount reductions and expense savings, in Q2-2012 and thereafter.
- Net loss for the quarter decreased by $348,011, or 16%, to $1,835,315 from $2,183,326.