Juvent: Clinical Trial Confirms New Device Improves Bone Density in Cancer Survivors

11% Increase in Bone Density in Study Published in the Journal of the American Medical Association (JAMA) Oncology

The Juvent Micro-Impact Platform
The Juvent Micro-Impact Platform

Regenerative Technologies Corporation

April 20, 2016

RIVIERA BEACH, FL–(Marketwired – April 20, 2016) – Juvent (www.juvent.com), a leader in orthopedic regenerative therapies for bone and musculoskeletal health, announced today very positive results from the St. Jude Children’s Hospital Clinical Trial. Kirsten K. Ness, PT, Ph.D., Principal Investigator, states, “The first goal of treating low BMD (bone mineral density) in childhood cancer survivors is to manage potential underlying causes including endocrine disorders and nutritional deficiencies. In our study using LMS (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 (SAB) 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 and SAB Member, 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 more rare. 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. 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 survivors1 who suffer from post-chemotherapy bone and joint damage. It also demonstrates the potential that this device could help the 14 million adult cancer survivors1 who struggle with similar problems. We plan to submit this data to the FDA to secure a clearance for this new indication,” says company Chairman & CEO, Rush Simonson.
David Brumfield, a leading biomechanical engineer and SAB Member, 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 (WBV) devices which produce much larger magnitudes & 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, thus improving the medical welfare of these who have already endured so much.”
“An 11% improvement in tibial BMD with no adverse events is a ‘home run’ by any criteria,” said Peter Simonson, a leading medical device developer, 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.  [see full press release]

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Blessings, Joy & Peace This New Year

I’m excited to start the new year with a new website and blog: Suncoast Healthy Life (www.suncoasthealthylife.com).  If you haven’t subscribed yet, please follow me to receive email updates including health and wellness tips, news, and events!   Thank you, Tamara

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My New Year reminder this year is to reflect on the radical and grandiose rigid resolutions in past years that never really worked! I invite you to consider the yogic approach to create and manifest the life you truly want to live.

How about trying something NEW this year? Why not plant seeds of intention to slowly move in the direction of the new path you would like to explore.

Consider the practice of yoga as a similar analogy to planting seeds of a beautiful rose bush. The process requires time to nurture and carefully cultivate before the first bud presents. Eventually in its own time the bud will blossom!

This year, take your yoga off the mat and into your life practicing the techniques to living mindfully, skillfully, and simply – allowing the beauty of life to unfold moment by moment, breath by breath, day by day.

Step 1)  Visualize the new intentions you would care to create.

Step 2)  Practice gently with self care and allow the process to begin.

Step 3)  Offer your best each and every day, then make a conscious choice to surrender the result or outcome.

Step 4)  Begin to accept (rather than resist ) whatever arises as we meet and greet ourselves and others each and every day.

Step 5)  Embrace discomfort and vulnerability when things are not going the way we would like. Knowing this too shall pass, it always does.

Step 6)  Keep your focus on the larger meaning of life, allowing everything to settle over time, be a witness to the drama rather than a participant. Eventually it all falls away.

Step 7)  Settle into the place of peace even when things do not happen the way you think you would like or expect. Be open to the surprises that might far exceed your original intention.

Step 8)  Choose consciously to discover your most joyful self, access hidden wells of energy, enhance creativity, love yourself and others unconditionally, embrace your truth, and live authentically!

 

Summer Salute to Seniors

As summer subsides on September 21, it is with great honor we acknowledge the spectacular moments enjoyed with many seniors who share the same pinnacle of life that summer represents.

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Thank you for offering yourselves wholeheartedly
; opening your minds, hearts and souls to explore the practices of yoga and meditation together (especially those of you in your 80’s and 90’s).  We are reminded of the very strong life force within each of us who dedicate our life, health and wellness as a beautiful gift to one’s self.   I am continually inspired by you….

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As we wind down our summer days on the beaches of the beautiful Long Boat Key Club, a special thank you goes out to all those who stopped by from out of town and to the regulars who participated in the playfulness within yoga, while witnessing porpoises, seabirds, manta rays, spectacular skies, crystal clear waters, and practicing in sugar sand.

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Stay posted for details on participating in the Long Boat Key Club Destination Vacation Winter 2014.

“And as the season transitions from summer’s last heat to autumn’s first signs, may we find the balance of the “equal night” within that which represents the autumnal equinox.

The autumn equinox is a mysterious time, marking an essential passage in the process of enlightenment that is often overlooked, misunderstood, and mistaken as dark and heretical. 

Sarasota sunset

It is the time of balance between day and night, before night takes over and brings 

the coming winter, a time of darkness and death. This duality between light and dark exists within humanity, and in the work of spiritual transformation. All things must die before they can be born, all spiritual ascent requires descent first, and all those who long for light must first face their own inner darkness and overcome it. The autumn equinox symbolizes a stage of inner preparation in the process of enlightenment—to make way for the Son to be born within at the winter solstice.” *

* http://belsebuub.com/articles/the-spiritual-meaning-of-the-autumn-equinox