Medical Device Company ZetrOZ and Clinical Research Partners Present Positive Results of NIH-Funded Clinical Studies at IEEE and World Physiotherapy Congress

TRUMBULL, CT--(Marketwired - May 4, 2015) - ZetrOZ announced positive results for the company's Phase I pilot study of its sam® device (Long Duration, Low Intensity Therapeutic Ultrasound Intervention for Osteoarthritis Pain Management) at The Institute of Electrical and Electronics Engineers, Inc. (IEEE) bioengineering conference. The results from the phase II randomized controlled trial were also competed successfully early this year and are being presented at The World Physiotherapy Congress in Singapore this week.

Results from the sam pilot studies show:

• Significant decrease in pain, as measured by a visual analog scale for pain (phase l study).
• Twenty percent increase in mobility in the treatment group, measured by a pedometer, and range of motion and strength both increased (phase I study).
• Forty per cent decrease in pain in the phase II randomized controlled trial on 47 subjects completed in January 2015 confirmed these findings on patients with moderate to severe arthritis pain as compared to 17% in the placebo group, which is clinically and statistically significant.

According to George K. Lewis, Jr., PhD, ZetrOZ Chief Scientific and Technology Officer, and Principal Investigator for the study, this work demonstrates the role for long-duration, low-intensity therapeutic ultrasound in the treatment of musculoskeletal pain resulting from osteoarthritis, as well as its impact on mobility and joint stiffness. The U.S. Center for Disease Control and Prevention estimates that 50 million adults in the U.S. have some form of arthritis, and that approximately one in two people will develop symptomatic knee osteoarthritis in their lifetime. 

"Persistent pain whether from arthritis or other pain-producing conditions is the number-one reason that patients access the healthcare system, according to the National Institutes of Health," said Dr. Lewis. "Pain seriously affects a patient's quality of life. While medications are often the first-line treatment for pain, they're not without side effects such as nausea, stomach pain, diarrhea and drowsiness. The ZetrOZ device does not negatively affect patients in these ways."  

"I was impressed with the outcome of this phase II clinical trial," said Dr. Ralph Ortiz, DO, MPH. "The use of sam showed clinically significant pain reduction and increase in range of motion over placebo. Also impressive were the active patient's improvement in quality of life. Further studies may indicate a slowing of the disease progression using sam, as therapeutic ultrasound has already been shown to enhance collagen production."

A longitudinal study intended to broaden these positive results on osteoarthritis pain reduction and study the effect of the intervention to slow progression of the debilitating disease is anticipated.

Lieutenant Governor Nancy Wyman has been a strong supporter of the partnership between ZetrOZ and the NIH in an ongoing and successful effort to promote Connecticut's biotech industry. The National Institutes of Health SBIR program which provided the initial funding for the study is a peer-reviewed grant program that provides research support to small businesses to discover and develop innovative biomedical products for the treatment of serious unmet medical needs.

About Ultrasound
Ultrasound has been used safely and effectively for years to provide pain relief and reduce joint contracture (stiffness). Additionally, the mechanical and thermal mechanisms triggered by ultrasound have been shown to facilitate wound and bone fracture healing, promote the penetration of topical ointments into the skin, and increase local circulation with a cascade of therapeutic biological benefit. Despite the potential of ultrasound therapy for treatment of pain and for healing, the therapy's mode of delivery, ease of safe and effective use, size of device, and price have traditionally prohibited its broad translation to the public. ZetrOZ ultrasound technology relies on aggressive miniaturization and integration of the ultrasound transducer, electronics, and power supply to produce a smaller, controlled release ultrasound system that can deliver portable, convenient, and effective therapy for long durations. 

About ZetrOZ, Inc.
ZetrOZ is a medical device manufacturer that is revolutionizing the medical therapeutic industry by introducing proprietary technology that is more efficient, more portable, and more economically viable than any ultrasound systems presently available. ZetrOZ's first product is the world's smallest and strongest ultrasound pain therapy device. The device was released in 2014, and is intended to addresses the demand for non-pharmaceutical alternatives to current pain treatments in the approximately $100 billion U.S. musculoskeletal pain management market. ZetrOZ is also known for developing the smallest ultrasound systems in the world, including the first swallowable ultrasound pill, and is the winner of numerous awards, including the 2014 Connecticut Technology Summit's Most Promising New Technology Product Company of the Year, the 2014 Beacon Medical Technology Award and 2013 Medical Device Excellence Award. For more information, visit www.zetroz.com.