Father Invents Balance Treatment Device for Daughter; Makes History with FDA Clearance AND Breakthrough Device Designation

GyroStim, a multi-axis rotational chair, was invented by a Colorado father in his garage to aid in his daughter's daily therapy regimen. With FDA clearance and breakthrough designation, UltraThera Technologies is poised to disrupt the healthcare industry and cut healthcare costs by billions of dollars annually.

COLORADO SPRINGS, Colo., Aug. 18, 2022 /PRNewswire/ -- On April 27, 2022, GyroStim became the first FDA-cleared device for treating balance disorders to receive FDA designation as a Breakthrough Device. This new balance treatment technology has potential to prevent falls and save the healthcare industry billions of dollars each year.

GyroStim is only the 46^th medical device in FDA history to be both designated as a Breakthrough Device and cleared for marketing. The FDA grants Breakthrough Device designation only to products the agency determines can "provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions" (FDA.gov).  

GyroStim is a computer-controlled, automated, multi-axis rotational chair. It provides therapeutic treatment for balance disorders resulting from injury, illness, and neurological or aging-related conditions. The treatment is uniquely capable of reducing or eliminating dizziness, imbalance, nausea, headache, fatigue, brain fog, memory loss, depression, anxiety, and other manifestations of balance disorders and vestibular dysfunction.

GyroStim was invented by UltraThera's CEO, Kevin Maher. The inspiration came from Maher's daughter, Mackenzie, who was born with cerebral palsy. Maher created a rotational chair in his garage made of a child's car seat, scraps of wood, and various hardware to provide her with balance therapy. Within weeks of using the rotational device, Mackenzie was making extraordinary and unexpected gains not only with balance but also in her overall development. Encouraged by her gains, Maher bootstrapped his way to producing the first automated GyroStim in 2007.

GyroStim's computer-controlled automation overcomes inherent limitations of the current standard of care (SOC). Retrospective preliminary clinical data indicate patients who receive GyroStim treatment in addition to SOC improve an average of 70% faster than with SOC alone. This translates to a significant reduction in falls, clinical treatment time, and financial burden for insurance companies, Medicaid, and Medicare.

Research shows that poor balance is causally related to falls (Yang, 2020), and improving balance will reduce falls (Kristinsdottir & Baldursdottir, 2014; Yang, 2020). While balance problems can occur at any age, statistics indicate the urgent need to reduce the number of falls among the elderly:

• "Every second of every day, an older adult suffers a fall in the U.S.—making falls the leading cause of injury and injury death in this age group." (CDC, 2020)
• Over 36 million falls were reported in 2018, stressing the enormous and pervasive problem in seniors. (Moreland et al., 2020)
• Each year about $50 billion is spent on medical costs related to fatal and non-fatal fall injuries in seniors (Florence, 2018)

Dr. Jeremy Schmoe has two GyroStim systems in his Minneapolis clinic, he states, "The outcomes we achieve with complex vestibular disorders, post-concussion syndrome, and dysautonomia are beyond anything we have seen before."

Maher admitted, "The road to marketing clearance and breakthrough device status hasn't been easy, but we've made huge progress over the past decade collecting data, improving the technology, and gaining acceptance within the medical community. The demand is there, and now, with the marketing green light from FDA and increased manufacturing capabilities, GyroStim is poised for exponential growth."

Kevin added with a smile, "It certainly never occurred to me when I was cobbling together that spinning chair for Mackenzie that it would evolve into a breakthrough technology and help countless individuals all over the world." 

UltraThera Technologies, Inc. has headquarters in Colorado Springs, CO, and manufacturing in Golden, CO.

Today, there are approximately 50 GyroStim systems in the U.S. and eight other countries, with installations at neuro-clinics, research labs, universities, including the Mayo Clinic AMVRL Lab and the U.S. Airforce Academy's Human Performance Lab.

GyroStim is protected with multiple patents, trademarks, and copyrights.

To learn more about GyroStim, request a press kit, or to schedule an interview with CEO Kevin Maher, please call 719-685-7883x101 or e-mail [email protected]. You can also visit the website at www.gyrostim.com.

SOURCE UltraThera Technologies, Inc.