Biowave Neuromodulation Therapy for Sports & Athletic Training

Transcription

1 Biowave Neuromodulation Therapy for Sports & Athletic Training A proven tool to manage pain from sports injuries, facilitate motion and accelerate rehabilitation biowave.com BIOWAVE Page 1 Biowave Neuromodulation Therapy A proven tool to manage pain from sports injuries, facilitate motion and accelerate rehabilitation

2 Who is Biowave? Biowave manufactures and sells FDA cleared high frequency neurostimulator medical devices Biowave neurostimulators provide profound non-pharmacological pain relief by delivering therapeutic high frequency electrical signals through skin directly to nerves to block pain signals. All of Biowave s medical devices are manufactured in the USA. BiowavePRO Page 2 Biowave Neuromodulation Therapy A proven tool to manage pain from sports injuries, facilitate motion and accelerate rehabilitation

3 Problem with Existing Stimulation Technologies TENS Electrodes Signal Transmission Across Skin Surface Location of Pain on Nociceptive Pain Fibers Cross Section of Body Skin Low Frequency signals (1-180 hz) affect nerve fibers Problem - skin has high impedance & capacitance Low Frequency (LF) signals regardless of the shape of the waveform cannot pass through skin - LF signals only travel across the surface of skin (Fundamental problem with TENS) Page 3 Biowave Neuromodulation Therapy A proven tool to manage pain from sports injuries, facilitate motion and accelerate rehabilitation

4 Solution to Problem Patented Biowave Advanced Signal Technology Proven in a rabbit model Delivery of Biowave s two summed High Frequency (HF) signals (4000 hz hz) alternates between two noninvasive electrodes Non-Invasive Electrodes Location of Pain on Nociceptive Pain Fibers Cross Section of Body Skin Biowave Active Electrical Field As the 2 HF signals pass through skin into deep tissue, all polarized structures including nociceptive pain fibers (C-fiber, A-delta fiber) and muscle tissue cause a further multiplication of the 2 HF signals (this is known as a Fourier Transform) Result is a new spectrum of signals, one of which is a Low Frequency (LF) signal that forms an active electrical field in a 3 diameter hemisphere beneath each noninvasive electrode Body is producing LF internally at surface of pain nerves instead of: 1. trying to force LF through skin from the outside like TENS, or 2. needing to implant a lead next to the nerve like a spinal cord stimulator (SCS) or peripheral nerve stimulator (PNS) Page 4 Biowave Neuromodulation Therapy A proven tool to manage pain from sports injuries, facilitate motion and accelerate rehabilitation

5 Result Very Simple to Use Neuromodulation Pain Therapy System No programming Signals are optimized for passing through skin and blocking pain directly on nociceptive fibers Only control is intensity Patients control their own comfort level Active feedback control prevents patients from receiving a burn Very simple to use FDA Cleared Manufactured in USA Page 5 Biowave Neuromodulation Therapy A proven tool to manage pain from sports injuries, facilitate motion and accelerate rehabilitation

6 Focusing of Active Electrical Field Active electrical field is focused by changing area of electrodes relative to one another B Set Electrodes Two 2 diameter noninvasive electrodes, both of equal area Density of electric field is equal beneath both electrodes Warning: Electrodes must never touch each other. 1 is the minimum spacing between B-set electrodes. Electrodes must be placed directly over 2 pain sites or over 1 pain site and over the origin of pain Used for Treating: Two Locations of Pain One Pain Site and Origin of Pain One Large Area of Pain Page 6 Biowave Neuromodulation Therapy A proven tool to manage pain from sports injuries, facilitate motion and accelerate rehabilitation

7 Focusing of Active Electrical Field Electrode Placement Example - Two Locations of Pain or Radiculopathy Two Distinct Locations of Pain e.g. Bilateral Lumbar Pain Origin of Pain and Most Proximal Location of Pain e.g. Radiculopathy Page 7 Biowave Neuromodulation Therapy A proven tool to manage pain from sports injuries, facilitate motion and accelerate rehabilitation

8 Focusing of Active Electrical Field Electrode Placement Example - One Large Area of Pain Chronic Pain Throughout the Knee e.g. Osteoarthritis (OA), Postoperative Pain from a Total Knee Replacement (TKR) Chronic Pain Throughout the Shoulder e.g. Osteoarthritis (OA), Adhesive Capsulitis, Anterior and Posterior Shoulder Pain Page 8 Biowave Neuromodulation Therapy A proven tool to manage pain from sports injuries, facilitate motion and accelerate rehabilitation

9 Focusing of Active Electrical Field Active electrical field is focused by changing area of electrodes relative to one another Warning: Electrodes must never touch each other. 1/2 is the minimum spacing between E-set electrodes. Page 9 Biowave Neuromodulation Therapy A proven tool to manage pain from sports injuries, facilitate motion and accelerate rehabilitation E Set Electrodes One small diameter round noninvasive pain site electrode One large 2 x 4 rectangular noninvasive dispersive electrode Density of electrical field is much greater under smaller round electrode Small round electrode is placed directly over location of single pain site Larger dispersive electrode must be placed over BONY PROMINENCE near the region being treated Bony prominence is most comfortable place to receive stimulation Patient can achieve higher intensity under the smaller electrode. Higher intensity = greater efficacy and longer residual benefit Used for Treating: One Location of Pain on the Extremities

10 Focusing of Active Electrical Field Electrode Placement Example - Single Location of Pain on the Extremities Placement for Myofascial Pain in Trapezius Placement for Patellar Tendinitis Page 10 Biowave Neuromodulation Therapy A proven tool to manage pain from sports injuries, facilitate motion and accelerate rehabilitation

11 Focusing of Active Electrical Field Active electrical field is focused by changing area of electrodes relative to one another Warning: Electrodes must never touch each other. 1/2 is the minimum spacing between electrodes. U Set Electrodes One 2 diameter round noninvasive pain site electrode Page 11 Biowave Neuromodulation Therapy A proven tool to manage pain from sports injuries, facilitate motion and accelerate rehabilitation One large 5 x 8 rectangular noninvasive dispersive electrode Density of electrical field is much greater under smaller round electrode Small round electrode is placed directly over location of single pain site in mid torso region of the body Larger dispersive electrode is placed horizontally across the lumbar area of the back, a comfortable place to receive stimulation Patient can achieve higher intensity under the smaller electrode. Higher intensity = greater efficacy and longer residual benefit Used for Treating: One Location of pain in the mid torso region of the body

12 Focusing of Active Electrical Field Electrode Placement Example - Single Location of Pain in the Mid-Torso Region One Location of Pain e.g. Hip One Location of Pain e.g. Hamstring Page 12 Biowave Neuromodulation Therapy A proven tool to manage pain from sports injuries, facilitate motion and accelerate rehabilitation

13 Biowave Sports Customers 30 NFL Teams 24 MLB Teams 24 NBA Teams 10 NHL Teams Numerous Olympic Sports Teams 150+ College Sports Programs Numerous High Schools and Private Schools Page 13 Biowave Neuromodulation Therapy A proven tool to manage pain from sports injuries, facilitate motion and accelerate rehabilitation

14 Clinically Proven 24 High Rate of Success Clinical studies show and physicians report that more than 80% of patients respond to Biowave treatments 1,2,3,4,5,6 Substantial Reduction in Pain Scores Patients that respond, report a 50-75% reduction in their VAS pain scores after one thirty minute treatment 1,2,3,4,5,6 Instant & Long- Lasting Pain Relief Pain relief is instant and lasts up to 24 hours 1,2,4,6 Reduced Opioid Use Biowave treatments have been proven to lead to a 50% reduction in patient controlled Opioid use 1,2 Page 14 Biowave Neuromodulation Therapy A proven tool to manage pain from sports injuries, facilitate motion and accelerate rehabilitation

15 Biowave Clinical Studies 1. Randomized Controlled Study on the treatment of post-operative pain from TKA surgery - Hospital for Special Surgery, New York City. Podium Presentation at Eastern Orthopedic Association Annual Meeting, Oct 2008; Poster. Presentation at AAOS Annual Meeting Feb 2009; Study submitted to the Journal of Arthroplasty. 2. Randomized Single-Blinded Controlled CIinical Trial of Biowave Percutaneous Electrical Nerve Stimulation (PENS) vs. Sham for the Osteoarthritic Knee Rush University Medical Center - Published in ORTHOPEDICS June Symptomatic Treatment of Chronic Low Back Pain Dosage Study (Phase 1 + 2) Weill Cornell Medical College; Abstract from Anesthesia & Analgesia, Mar Randomized, Double-Blinded, Comparative Crossover Trial of the Safety and Efficacy of Biowave vs. Transcutaneous Electrical Nerve Stimulation (TENS) for the Symptomatic Treatment of Chronic Low Back Pain, (Phase 3) Weill Cornell Medical College; White Paper Sept NY Giants White Paper - IRB approved study on the treatment of Acute Sports Injuries on NY Giants football players June 2003-Dec 2005, 600 treatments on 90 players 6. Clinical Study on treating extremities to reduce pain and improve range of motion August 2005 Page 15 Biowave Neuromodulation Therapy A proven tool to manage pain from sports injuries, facilitate motion and accelerate rehabilitation

16 Biowave Treatment Protocol - 1 Static 30-minute pain treatment Treat not only in the training room but during meetings, in the hotel room, on airplanes and buses. Treatment duration is 30-minutes. Easy to use - no programming - set up takes 2 minutes Athlete controls their own comfort level by pressing the PLUS button Software prevents the possibility of receiving a burn Treatment is very comfortable so player compliance is excellent Page 16 Biowave Neuromodulation Therapy A proven tool to manage pain from sports injuries, facilitate motion and accelerate rehabilitation

17 Biowave Treatment Protocol - 2 Facilitate motion and manage pain simultaneously Biowave helps to facilitate rehabilitation. Use in place of heat, for 8 minutes to allow the effect of the electrical field to occur on the C-fibers, A-delta fibers, muscle tissue and to provide increased blood flow in the volume of tissue treated. Cohesive wrap, tape or a velcro strap is wrapped around the electrodes to help hold them in place. After the first 8 minutes, intensity is reduced by 10% to reduce the sensation the athlete feels from the electrical field. After the intensity is reduced, the athlete begins active or passive range of motion, exercise or stretching therapy during the remainder of the 30-minute Biowave treatment. Patients can move more resistance through a greater range of motion with significantly less pain. Biowave removes the guarding effect associated with pain and significantly facilitates the ability of the athlete to perform therapy. Additionally, because of the long carry over effect, athletes have little post exercise soreness. Page 17 Biowave Neuromodulation Therapy A proven tool to manage pain from sports injuries, facilitate motion and accelerate rehabilitation

18 Next Steps 1. Inservice Schedule a date to train your customer on the protocols including electrode placement and show how our high frequency neurostimulation can help speed the recovery of their athletes Day Money Back Guarantee Use Biowave for 30 days to see evidence based results on a wide range of patients. The proof is in the pudding. 3. Purchase BiowavePRO For professional sports BiowavePRO systems can be purchased for injured players through workers compensation. Biowave has relationships with numerous workers comp firms and has a simple one page form for the customer to complete. Page 18 Biowave Neuromodulation Therapy A proven tool to manage pain from sports injuries, facilitate motion and accelerate rehabilitation