“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,” said Sam Owen, CEO and founder of Otolith Labs. “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.”
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.
Though Otolith Labs’ technology is not yet available, in the first arm of an ongoing clinical study, 87.5 percent of the 40 participants reported a reduction in their vertigo within five minutes of turning on the Otolith device. Dr. Michael Hoffer, professor of Otolaryngology and Neurological Surgery at the University of Miami’s Miller School of Medicine, said, “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.”