Otolith Labs announced this week that it has received U.S. Food and Drug Administration (FDA) ‘BREAKTHROUGH DEVICE’ designation for its medical device that is designed to be prescribed by physicians for the treatment of vertigo.
Otolith Labs’ noninvasive VESTIBULAR SYSTEM MASKING (nVSM) technology is designed to provide acute treatment for vestibulogenic vertigo.
The headband device (see photo above) applies localized mechanical stimulation to the vestibular system through calibrated vibrations. It is primarily intended for use by chronic vertigo patients, for whom there are limited treatment options.
“We’ve heard repeatedly from participants in our clinical studies that the Otolith technology brings instant relief from their vertigo symptoms, some of whom have described the treatment as life-changing. The FDA Breakthrough Device designation will empower us to expedite the availability of our technology for the more than four million people with chronic vertigo who currently lack any viable alternative.”
—Sam Owen, CEO and Founder of Otolith Labs
Mark Cuban, billionaire entrepreneur, vestibular patient, and investor in Otolith Labs, said, “I have experienced first-hand the debilitating nature of vestibular issues and limited treatments. I am therefore extremely pleased that the FDA has recognized the potential for Otolith’s breakthrough technology.”
Mr. Cuban has invested in Otolith via his Radical Investments firm.
Ongoing Clinical Study
Though Otolith Labs’ technology is not yet available, in the first arm of an ongoing clinical study, 87.5% of the 40 participants reported a reduction in their vertigo within five minutes of turning on the Otolith device.
“The breakthrough designation from FDA fast-tracks a prescription device therapy that may help millions of American who are now forced to live with significant chronic vertigo,” said Dr. Michael Hoffer, Professor of Otolaryngology and Neurological Surgery at the University of Miami Miller School of Medicine
The FDA Breakthrough Device program helps patients receive more timely access to innovative technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Otolith Labs with priority review and interactive communication regarding clinical trial designs and commercialization decisions.
Caution: Investigational device limited by United States law to investigational use.
Note: Revenue is from Department of Defense Research Grants and is non-sales related.
About Otolith Labs
Otolith Labs is pioneering the first medical wearable for the treatment of vertigo, a symptom experienced by more than 15 million Americans. Otolith’s patented non-invasive head-worn technology uses precisely tuned vibrations to interact with the motion sensors in the inner ear, mitigating the symptoms of vertigo and motion sickness. This novel technology has been validated by several clinical studies, including multiple independent studies at universities and with leading automotive manufacturers. Otolith plans to submit to the FDA for 510(k) De Novo approval in 2022.
Source: Otolith Labs