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ZetrOZ, Inc. Awarded $397,000 NIH Grant


December 12, 2013 - Trumbull, CT

ZetrOZ, Inc. today announced that it has been awarded a Phase I Small Business Innovation Research (SBIR) grant totaling $397,000 from The National Institute on Minority Health and Health Disparities of the U.S. National Institutes of Health to evaluate the effectiveness of its long-duration wearable ultrasound therapy technology for pain management in osteoarthritis. The milestones of the project include refinement of the device for the treatment of knee osteoarthritis and clinical evaluation of daily treatment to improve patient quality of life and alleviate arthritis pain. Preliminary studies conducted by the investigative team suggest that daily wearable ultrasound treatment provides an effective non-pharmaceutical approach to arthritis pain management.

According to George K. Lewis, Jr., PhD, Company Chief Scientific Officer and Co-Founder, and Principal Investigator for the grant, the study will be designed to increase scientific understanding of long-duration low-intensity therapeutic ultrasound for 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 1 in 2 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 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."

For the study, the device will be clinically evaluated on subjects diagnosed with osteoarthritis of the knee. Over the multi-week, outpatient study, patients will be monitored for reductions in pain and joint stiffness, increased mobility, improved quality of life and their use of pharmaceuticals for pain control.

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.

The new ZetrOZ ultrasound delivery system relies on aggressive miniaturization and integration of the ultrasound transducer, electronics, and power supply to produce a smaller, low-intensity ultrasound system that can deliver portable, convenient, and effective therapy for long durations. It is currently CE marked and cleared in Europe for sale, and under FDA review for market clearance in the United States.

Lewis explains, "Our hope is to provide the first non-drug, non-invasive, portable, transformative solution to pain control."

The National Institutes of Health SBIR program 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 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. This device, slated for launch in early 2014, addresses the demand for non-pharmaceutical alternatives to current pain treatments in the approximately $62 billion U.S. pain management market. ZetrOZ is also known for developing the smallest ultrasound systems in the world, including a recent collaboration with MIT that spun out the first swallowable ultrasound pill. For more information, visit www.zetroz.com.

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