High Frequency Resonance Improves Bone Density

A device that uses a unique resonant technology to deliver thousands of low-magnitude and high-frequency micro-impacts through the heels of the feet safely stimulates the body’s muscles and bones to rebuild. Users stand on the Juvent Regenerative Technologies Corporation platform for as little as 10 minutes per day and many begin to feel joint pain relief within days, according to the manufacturer’s press release. Juvent’s Micro-Impact Platform is registered as a FDA Class I medical exercise and rehabilitation device.

A St Jude Children’s Hospital Clinical Trial of the Juvent device resulted in an 11% increase in bone density. The study is published in the Journal of the American Medical Association.

Kirsten K. Ness, Ph.D., the principal investigator for the study, stated, “The first goal of treating low bone mineral density (BMD) in childhood cancer survivors is to manage potential underlying causes including endocrine disorders and nutritional deficiencies. In our study using the Juvent Dynamic Motion Therapy Platform, we managed endocrine problems and supplemented everyone on the study. Our randomized study was effective in improving total body and tibial BMD in children randomized to the device while children in the placebo group had decreases in BMD. Importantly, we had no adverse events with a year of twice daily 10 minute sessions. This portable device is safe and effective as an intervention for childhood cancer survivors who have low BMD and whose endocrine and nutrition status is well managed.”

Gunnar Andersson, M.D., Ph.D., Chairman Emeritus of Orthopaedic Surgery at Rush Presbyterian, past president of the Orthopaedic Research Society and Juvent Science Advisory Board Member, stated, “This is a very important study with a spectacular result from a short period, non-invasive intervention that has no side effects.”

Richard Treharne, Ph.D., a leading FDA regulatory expert, said, “Randomized studies of orthopaedic devices are rare; with double-blind studies with placebo controls even rarer. To find any therapy that can increase total body bone mineral density is even rarer. The results from this study using a challenging patient population are striking, most encouraging, and warrant further study.”

“This is our first cancer patient study, ” said Company Chairman and CEO Rush Simonson. “Our other successful pediatric bone studies improved bone density with Cerebral Palsy, Thalassemia and Scoliosis patient populations. We believe this study creates a new standard of care and will move this important technology into children’s hospitals and pediatric clinics to help the over 300, 000 pediatric cancer survivors who suffer from post-chemotherapy bone and joint damage. It also demonstrates the potential that this device could help the 14 million adult cancer survivors who struggle with similar problems. We plan to submit this data to the FDA to secure a clearance for this new indication.”

“An 11% improvement in tibial BMD with no adverse events is a ‘home run’ by any criteria, ” said Peter Simonson, Georgia Tech mechanical engineer and Juvent president. “This study is another confirmation that the years of development of our patented software and mechanism was worth it. The software’s ability to automatically adapt to a user’s unique body mass and composition is the key, ” said Simonson.

David Brumfield, a biomechanical engineer, said, “Juvent’s platform offers an easy means of applying a proprietary, low-magnitude mechanical stimulation (LMMS; 0.3 g) calibrated to one’s own unique resonant frequency within a safe 32-37Hz range. As such, its use is more effective and safer than whole body vibration devices which produce much larger magnitudes and frequencies with their associated side effects. This well-conducted study demonstrates that the safe and effective Juvent technology helped restore musculoskeletal health in these patients whose bone strength has been impaired by cancer treatments.”

Juvent, located in Riviera, Florida, is a part of Regenerative Technologies Corporation, a privately held, Florida-based company that manufactures the Juvent Micro-Impact Platform in the U.S. The platform provides non-invasive, micro-impact pulses to support bone health, lymphatic drainage, relieve joint and back pain, and enhance balance. In the U.S., the Juvent 1000N device is considered investigational for the treatment of osteoporosis or improvement/maintenance of bone mineral density.