The Company has sponsored six (6) clinical studies for regulatory and marketing purposes that are run under Investigational Review Board (IRB) approvals. 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.



  Clinical Study #6:

A 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.

Hospital for Special Surgery
New York, NY

Dr. Scott Rodeo, Dr. Russell Windsor, Principal Investigators


Clinical Study #5:

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. Brian Cole, Principal Investigator

Download Deepwave OA Knee Study
  Clinical Study #4:

White Paper - Use of a Neuromodulation Pain Therapy Device (“Sportswave®”) to Treat Acute Sports Injuries.

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:

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. Sunil Panchal, Dr. Hugh Hemmings, Principal Investigators


Clinical Study #2:

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:

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
 
Summary Results of Clinical Studies:

Clinical Study #1:
Dosage Study to Determine (1) Optimal Device and Disposable Parameters and (2) Preliminary Efficacy for the Treatment of Chronic Low Back Pain
Weill Medical College of Cornell University/ New York Presbyterian Hospital
New York, NY

The first study was a dosage study completed at Weill Medical College of Cornell University/ New York Presbyterian Hospital. The purpose of the study was to determine (1) optimal frequency settings for the device, (2) optimal length of treatment, (3) optimal electrode size and placement, (4) safety, and (5) preliminary efficacy. The study focused on patients with chronic low back pain. There were 50 treatments performed on 18 patients. The results of the study across all 50 treatments were that after a 20-minute treatment, the average percent reduction in pain from before to after was 78%. Pain reduction was measured using a standard Visual Analog Scale (“VAS”). At the optimal frequency setting, the average percent reduction in pain from before to after was 82%. Many patients also had residual pain relief ranging from 6 hours to 48 hours following the treatment. Range of motion was also significantly improved from before to after treatment. An abstract on the first dosage study completed at Weill Medical College of Cornell University was listed in the March 2003 peer-reviewed journal, Anesthesia & Analgesia, and was presented as a Poster at the March 2003 International Anesthesia Research Society (IARS) annual meeting.



 

Clinical Study #2:
Dosage Study to Determine (1) Optimal Parameters for the Disposables and (2) Preliminary Efficacy for Treating Pain in the Neck, Shoulder, Elbow, Wrist, Hip, Knee, and Ankle.
Coren Clinic, Norwalk, CT

The second IRB-approved study was conducted to determine optimal pad size and pad placement as well as efficacy for the treatment of shoulder, knee and hip pain as well as pain in the extremities including neck, face, arms, elbow, wrist, hands, legs, ankles and feet. The study also compared efficacy in patients that have three treatments versus one treatment. The study size was designed to be 90 treatments on 50 patients. The data collected suggests that the BIOWAVE Electronic Pain Management Device is an effective treatment for relieving symptomatic musculoskeletal pain in the extremities. Median VAS scores, based on all data points, at the end of the 20-minute treatment, and at 6 and 24 hours following the treatment, were significantly below the baseline VAS score for all locations tested on the body. The median percent reduction in pain across all data points following the treatment were 64% at 0 hours, 59% at 6 hours and 53% at 24 hours post treatment.

Most other clinical studies that are focused on evaluating the efficacy of a pain management device rate the efficacy of the device based on the percentage of patients that achieve 50% or greater pain relief. For Biowave treatments, the median percentage of patients that received 50% or greater pain relief immediately post-treatment was 76%. At 6 hours post treatment, 68% of the patients still had a 50% or greater reduction in pain and most significantly, at 24 hours post treatment, 54% of the patients had a 50% or greater reduction in pain.




Clinical Study #3:
 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

The third IRB-approved study is a double blinded, randomized, controlled study comparing Biowave vs. an active control (TENS) for the treatment of chronic low back pain. The study size is 68 treatments on 34 patients. Each patient receives one 20-minute treatment on each device, separated by one week, the order of which is randomized. The patients as well as one investigator are blinded from the devices, which are concealed in a carton. The leadwires and pads used in this study are identical in appearance for each treatment and each patient is connected to three pads, which in turn are connected to three leadwires emanating from the carton. One large pad is placed on the abdomen, and two smaller pads on the lower back. For the Biowave treatment, only one of the pads on the lower back and the pad on the abdomen are active. For the TENS device, only the two pads on the back are active. The protocol was approved by the IRB at Cornell Medical Center/NY Presbyterian Hospital, and to date 28 patients have completed the study.

An interim analysis was performed when 18 patients completed the study. The analysis showed that the average percent reduction in pain for the Biowave device across all 18 patients was 82% at 1 hour, 82% at 6 hours and 73% at 24 hours post treatment, versus 63% at 1 hour, 63% at 6 hours and 36% at 24 hours for TENS. Patients treated with Biowave also experienced a significant increase in range of motion for up to 24 hours post treatment.

The interim analysis shows that in this controlled, randomized, double blinded study for the treatment of chronic low back pain, Biowave has a 24% improvement over TENS at one hour post treatment, and a 51% improvement over TENS at 24 hours post treatment.