ALPHARETTA, Ga.--SANUWAVE, Inc., (OTC BB: RBME) (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, has become the subsidiary of a publicly traded company through a reverse merger with a wholly-owned subsidiary of Rub Music Enterprises, Inc. (“RME”). Pursuant to the merger agreement, which became effective September 25, 2009, SANUWAVE is the surviving entity in the reverse merger with RME’s subsidiary. RME’s common stock is traded on the OTC Bulletin Board under the symbol “RBME.” SANUWAVE intends to change RME’s name and apply for a stock symbol change that more closely reflects SANUWAVE’s name.
SANUWAVE intends to apply its proprietary Pulsed Acoustic Cellular [removed]“PACE™”) technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. It is developing a platform of products that activate biologic signaling and angiogenic responses, including new vascularization and microcirculatory improvement, helping to restore the body’s normal healing processes and regeneration.
Christopher M. Cashman, President and CEO of SANUWAVE and now RME said, “Becoming a public company is another important milestone for SANUWAVE as we strive to bring to market safe and effective, non-invasive technologies in regenerative medicine for the repair and regeneration of tissue, musculoskeletal and vascular structures. We believe we have a robust research and development pipeline, experienced management and research teams, and broad patent protection. As a public company we expect to have more access to the capital markets to help further the development and commercialization of our products.”
He continued, “Our immediate focus is the potential $5 billion U.S. advanced wound care market. With our Investigational Device Exemption (IDE) wound care study on diabetic foot ulcers in progress, we look forward to continuing our developmental activities and bringing our lead product, dermaPACE™, to the market. We remain on track to complete enrollment by June 2010, and look forward to submitting our Premarket Approval (“PMA”) application to the FDA in 2011.”
Patient enrollment for the dermaPACE IDE trial for healing diabetic foot ulcers recently reached 75% completion. The trial has 22 sites, with 20 in the U.S. and two international sites in the United Kingdom and Germany. The objective of this clinical study is to compare the safety and effectiveness of the dermaPACE™ device to sham application, when administered in conjunction with the standard of care, in the treatment of diabetic foot ulcers. It is a randomized, double blind, placebo control, parallel assignment study design.
SANUWAVE believes it has already demonstrated that its technology is safe and effective in stimulating healing in certain chronic conditions of the foot and elbow through its U.S. Class III PMA-approved Ossatron® device, and in the stimulation of bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its Ossatron® and Evotron® devices in Europe. Its lead product candidate for the global wound care market, dermaPACE™, has received the European Conformity Marking (CE) for commercial use on acute and chronic defects of the skin and subcutaneous soft tissue. It is currently being marketed in Europe through distributors in select countries.
Mr. Cashman concluded, “We believe our PACE™ technology provides us with additional opportunities outside of wound care for business expansion, and our ongoing research in orthopedics, spine/neuro, plastic/aesthetics and cardiac areas is paving the way to enter those markets. With a legacy of commercial development and Class III PMA regulatory successes, we look forward to achieving our future milestones.”
In connection with the reverse merger, RME issued approximately 11.0 million new shares of its common stock and 2.2 million warrants to purchase its common stock. Also in connection with the reverse merger, RME repurchased and canceled 39.2 million shares of its outstanding common stock. After the reverse merger, there are a total of approximately 12.5 million shares of RME common stock outstanding, with former SANUWAVE shareholders holding approximately 88% on a fully-diluted basis. The shares issued to former SANUWAVE shareholders in the reverse merger were issued pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended, and are not presently eligible for resale to the public. In addition, after the reverse merger, there are 3.7 million warrants outstanding to purchase RME’s common stock. As of September 25, 2009, RME had $3.3 million of cash and cash equivalents. The executive officers and directors of SANUWAVE became the executive officers and directors of RME upon the closing of the reverse merger. Further information on the reverse merger can be found in RME’s Current Report on Form 8-K filed with the Securities and Exchange Commission on September 30, 2009.
About SANUWAVE, Inc.
SANUWAVE, 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 [removed]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 Investigation Device Exemption trial in the U.S. for the treatment of diabetic foot ulcers. SANUWAVE 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 (planter fasciitis) and the elbow (lateral epicondylitis) through it’s U.S. Class III PMA approved Ossatron® device and in the stimulation of 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™ trial, please visit www.dermapace.com.
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