Key story highlights:
- Otolith Labs is developing a vibrating device to alleviate symptoms associated with vertigo and motion sickness.
- The company plans to raise roughly $5 million this fall, to take the product through clinical trials and, ultimately, to market.
- CEO Sam Owen said he hopes to have approval from the Food and Drug Administration to commercialize the product by this time next year.
Treating vertigo is tricky. But what if getting rid of debilitating dizziness and nausea were as easy as wearing a headband?
Sam Owen thinks it can be.
The CEO of Otolith Labs, a D.C. biotech he founded in January 2015, is developing a vibrating device, worn over the head and bony areas behind the ears. It essentially confuses the vestibular system — a set of senses in the inner ear that process the information that controls balance.
The purpose? Alleviate the symptoms associated with vertigo, motion sickness, vestibular migraines and other balance disorders.
Otolith Labs — named for the small structures in the inner ear that help perceive movement and gravity — is now taking steps to bring this product to market, important because treatment options are limited to physical therapy and select drugs that suppress the vestibular system. Its roadmap includes clinical trials, a marketing campaign and a roughly $5 million raise this fall. That capital would be used to build a sales team, finish the product and take it to the Food and Drug Administration for approval by October.
“We spent the last three years creating what is quite possibly the world’s quietist and most efficient vibrating device,” Owen said. “Once we were able to accomplish that, in working with researchers out of the University of Maryland and Walter Reed, we were able to really define, in a quantitative way, the effective power range and frequency ranges in which this works, and now we have a device that we’re going to the FDA with, that seems to be a miracle cure for things vestibular related.”
Owen hopes to be able to market the product by this time next year, he said.
The company is already piloting with physical therapists and doctors, and in Afghanistan with the U.S. military, one of four major markets with opportunity for commercialization, where motion sickness is a major problem, Owen said. Medical, consumer and virtual reality sickness are the other three.
His team first intends to seek a “De Novo” designation from the FDA — meaning it’s the first device of its kind — for use as a take-home device for motion sickness, and as an in-clinic device for VNG testing (to prevent vertigo symptoms without affecting the test aimed at identifying their cause). The team is pursuing these uses first because it already has the data for them, and it wants to get to the FDA as quickly as possible, Owen said. But it plans to later seek additional approvals, so doctors may prescribe the headband as a take-home tool for vertigo.
The device would both work in conjunction with physical therapy, to enable patients to complete their sessions by improving symptoms, and serve as a possible alternative to medications that take longer to metabolize and often have sedating side effects, Owen said. Otolith Labs expects to start a clinical study at the University of Maryland School of Medicine in Baltimore next week, and launch another clinical trial at the University of Miami at the end of the summer. It’s also in the process of identifying an independent lab to lead more testing.
The 3-year-old biotech, with five full-time employees and seven part-time workers, has raised nearly $1 million to date. Owen invested $65,000 of his own money in its first two years, then landed funding from local angel investors. He was also part of the D.C.-based Halcyon Incubator program, after starting the business based on research while earning his doctorate in physics at Georgetown University.
Other health care companies are also working to solve the vertigo-treatment challenge. French biopharmaceutical company Sensorion is working on an oral medication that could be the first therapeutic for vertigo, while Seattle-based Sound Pharmaceuticals is in clinical trials for a drug to treat Meniere’s Disease, which causes vertigo.
The company plans to raise roughly $5 million this fall, hoping have approval from the Food and Drug Administration to commercialize the product by this time next year.