Health & Fitness
Health and Fitness
Health and Fitness
Wed, August 24, 2011
Tue, August 23, 2011 SANUWAVE Health Granted U.S. Patent on Use of Acoustic Shock Waves to Treat Orthopedic Conditions
ALPHARETTA, Ga.--([ BUSINESS WIRE ])--SANUWAVE Health, Inc. (OTCBB: SNWV), an emerging medical technology company focused on the development and commercialization of noninvasive, biological response activating devices in regenerative medicine, today announced that the United States Patent and Trademark Office issued U.S. patent 7,985,189 entitled "Method For Using Acoustic Shock Waves in the Treatment of Medical Conditionsa to the Company.
"Method For Using Acoustic Shock Waves in the Treatment of Medical Conditions"
The patent covers the treatment of a variety of orthopedic conditions, such as tendinitis (chronic joint inflammation and pain), osteoporosis (brittle bones with an increased risk of fracture) and actual bone stress fracture healing. Treatments are characterized as acoustic shock wave applications, that under the patented treatment times and energy dosages, cause the stimulation of growth factors and a resulting increase in new blood vessel formation to promote or accelerate the bodya™s natural healing processes and responses, thereby inducing or accelerating healing.
Christopher M. Cashman, President and CEO of SANUWAVE, said, aThe issuance of this patent provides strong and broad intellectual property protection for PACE® (Pulsed Acoustic Cellular Expression) technology in a variety of musculoskeletal indications whose combined market potential exceeds $1 billion in the U.S. alone. This is particularly important as we begin to execute our regulatory strategy for orthoPACE® in the U.S. In addition, it strengthens the patent portfolio we are building around our proprietary form of extracorporeal shock wave technology (ESWT) called PACEtechnology and provides significant barriers to entry for any would-be competitors.a
Orthopedic, sports medicine and trauma conditions treated with PACE, including tendinitis, osteoporosis and bone healing, have documented success rates that are equal to and often greater than that of surgery a" usually with just one procedure and without the inherent risks, complications and lengthy recovery time associated with invasive surgery. Most procedures can be performed in less than 15 minutes, and patients can return home the same day. Patients can usually bear weight immediately and are able to return to normal activity within a few days of the procedure. PACE procedures are completely noninvasive so there is no risk of infection or scarring, and more importantly, PACE treatment preserves the opportunity for future treatment options, as it does not change the biomechanics of the underlying musculoskeletal system.
About orthoPACE
The orthoPACE system incorporates the Companya™s proprietary PACE technology platform that delivers extracorporeal shock waves to treat a wide variety of chronic and acute conditions in bone and soft tissue. This device has a compact, portable design and allows for procedures to be performed by a single operator in both the hospital and office setting. Also, orthoPACE features a new, unique applicator that may reduce or completely eliminate anesthesia for some patients. These novel benefits have the potential to significantly increase clinical efficiency, patient access and comfort, and ultimately utilization. The orthoPACE system does not currently have FDA approval in the U.S., and it is CE marked for bone and soft tissue indications in Europe.
About PACE
PACE, defined as Pulsed Acoustic Cellular Expression, delivers high-energy acoustic pressure waves in the shock wave spectrum to produce compressive and tensile stresses on cells and tissue structures to promote angiogenic and positive inflammatory responses, and quickly initiate the healing cascade. This results in revascularization and microcirculatory improvement, including an increase in arterial vessel diameter (arteriogenesis), 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 an accelerated inflammatory response that speeds wounds into the proliferation phase of healing and subsequently returns a chronic condition to an acute condition, to help reinitiate the bodya™s own healing response.
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. SANUWAVEa™s portfolio of products and product candidates activate biologic signaling and angiogenic responses, including new vascularization and microcirculatory improvement, helping to restore the bodya™s 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 its 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, Evotrona" and orthoPACE devices in Europe.
Forward-Looking Statements
This press release may contain aforward-looking statementsa 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 Companya™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 Companya™s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Companya™s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Companya™s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.
