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The Company has sponsored six (6) clinical studies for regulatory and marketing purposes that were run under Investigational Review Board (IRB) approvals. The studies involve the treatment of pain from arthritis, chronic low back pain, joint pain, acute pain from sports injuries and the treatment of post-operative or post-surgical pain from total knee replacement (TKR) surgery, also called total knee arthroplasty (TKA). Additionally, the Company's strategic partners have also run clinical studies to evaluate Biowave's safety and efficacy as part of their own due diligence. |
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Clinical Study #6 - Post-Operative Pain Treatment following Total Knee Replacement Surgery: A Randomized Controlled Pilot Study To Determine Average Maximum Intensity Settings, Safety, And Initial Efficacy In Terms Of Pain Reduction, Increased Range Of Motion, And Reduced Pain Medications, For A Percutaneous Neuromodulation Pain Therapy Device (“Deepwave®”) Following Post-Operative Treatments For Total Knee Replacement Procedures. Podium Presentation occurred at the Eastern Orthopaedic Association 39th Annual Meeting, Oct 22-25, 2008, Henderson, NV. Poster Presentation occurred at the American Academy of Orthopaedic Surgeons 2009 Annual Meeting, February 25-28, 2008, Las Vegas, Nevada Hospital for Special Surgery New York, NY Dr. Tony Wanich, Dr. Jonathan Gelber, Dr. Russell Windsor, Dr. Scott Rodeo, Principal Investigators Download Deepwave HSS TKR Pain Study Manuscript Clinical Study #5 - Treatment of Chronic Pain from Arthritis (Osteoarthritis) of the Knee: Prospective Randomized Single-blinded Controlled Clinical Trial of a Percutaneous Neuromdulation Pain Therapy Device Versus Sham for the Osteoarthritic Knee. ORTHOPEDICS, June 2007, Volume 30, Number 6. Published peer-reviewed manuscript. Rush University Medical Center Midwest Orthopedics Chicago, IL Dr. Richard Kang, Dr. Brian Cole, Principal Investigators Download Deepwave OA Knee Study Clinical Study #4 - Treatment of Acute Pain from Sports Injuries: White Paper - Use of a Neuromodulation Pain Therapy Device (“Sportswave®”) to Treat Acute Sports Injuries on Players of the New York Giants Football Team, June 2003 - Dec 2005. New York Giants Football Team Giants Stadium East Rutherford, NJ Dr. Sunil Panchal, Dr. Joseph Pergolizzi, Principal Investigators Download Sportswave Whitepaper on Treatment of Acute Sports Injuries Clinical Study #3 - Treatment of Chronic Low Back Pain: Double Blinded, Randomized, Controlled, Crossover Study Comparing Biowave vs. TENS (as an Active Control) for the Treatment of Chronic Low Back Pain. Weill Medical College of Cornell University/ New York Presbyterian Hospital New York, NY Dr. Sudhir Diwan, Dr. Hugh Hemmings, Dr. Sunil Panchal, Principal Investigators Download Homewave vs. TENS Clinical Study on the Treatment of Chronic Low Back Pain Clinical Study #2 - Treatment of Chronic and Acute Joint Pain: Homewave Dosage Study to Determine (1) Optimal Parameters for the Disposables and (2) Preliminary Efficacy for Treating Pain in the Neck, Face, Shoulder, Elbow, Wrist, Hip, Knee, and Ankle. Coren Clinic Norwalk, CT Dr. Wendy Coren, Principal Investigator Download Homewave Extremity Clinical Report Clinical Study #1 - Treatment of Chronic Low Back Pain: Dosage Study to Determine (1) Optimal Device and Disposable Parameters and (2) Safety and Preliminary Efficacy for the Treatment of Chronic Low Back Pain. Abstract in Anesthesia & Analgesia, March 2003. Weill Medical College of Cornell University/ New York Presbyterian Hospital New York, NY Dr. Hugh Hemmings, Principal Investigator Download Homewave Abstract from Anesthesia & Analgesia |
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