Otolith Labs is developing a prescription wearable medical device that uses calibrated vibrations (nVSM) to interact with inner‑ear acceleration sensors and provide immediate symptom relief for chronic vertigo. The company’s flagship nVSM technology is noninvasive and non‑pharmacological, intended as a first prescription wearable therapy for vestibular disorders affecting millions of Americans. Otolith has received FDA Breakthrough Device Designation for the prescription treatment of chronic vertigo and plans to enroll a pivotal study to further evaluate effectiveness. In pilot studies of ~100 subjects, the active nVSM group was more than three times as likely to report improved symptoms versus placebo (p < 0.05). Proceeds from the recent raise will support ongoing clinical programs, the anticipated FDA approval pathway, and the company’s first commercial launch. Company leadership is engaging the otolaryngology community to prepare for rapid development and adoption of the therapy. Otolith Labs develops a headband medical device using noninvasive vestibular system masking (nVSM) that applies calibrated mechanical vibrations to provide acute treatment for vestibulogenic vertigo. The device is intended primarily for chronic vertigo patients who currently have limited treatment options. In an early arm of an ongoing clinical study, 87.5% of 40 participants reported a reduction in vertigo within five minutes of turning on the device. The company has generated nearly $2 million in revenue to date from Department of Defense research grants (non-sales related). Otolith announced FDA Breakthrough Device designation, which the company says will provide priority review and interactive communication to expedite availability and commercialization. The company was launched at the Halcyon Incubator and is led by CEO and founder Sam Owen.

Total raised

$23M

Funding rounds

2

Latest round

Series A

Latest activity

Sep 2022