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University of Iowa spin-out company Voxello is quickly clearing hurdles in its run to be the first medical device of its kind on the market.

It recently received its ETL Listed Mark certification (proof that your product has been independently tested and meets the applicable published standard) for electrical and safety compliance testing on the noddle™, a medical device that allows patients with physical impairments to communicate with hospital staff. This, along with the establishment of a full quality management system, allowed the company to submit its 510(k) application for market clearance to the FDA on Oct. 3.

The noddle™ was developed by UI Communication Sciences and Disorders Professor Emeritus Richard Hurtig, now Chief Scientific Officer of Voxello. The device allows patients who are unable to speak to communicate effectively through subtle movements like a tongue click, hand movement, or eye blink. Clinical trials are ongoing for the noddle™ at the University of Iowa Hospitals and Clinics. Gaining market clearance will allow the pool of trial sites to broaden to other high profile academic centers around the United States.

Voxello signed an exclusive licensing agreement with the UI Research Foundation in 2015.  Additionally, Voxello received GAP funding from the UI Office of Research and Economic Development’s UI Ventures program.

“Voxello is an excellent case study in how research and new knowledge from the University of Iowa is meeting public needs,” said Dan Reed, UI Vice President of Research and Economic Development. “We are committed to ensuring research innovation reaches the marketplace.”   

Voxello Chief Executive Officer Rives Bird said there is an emerging market for the noddle™. In 2012, The Joint Commission–the accreditation and certification body for the health care industry–mandated that care facilities provide appropriate communication avenues for patients who can’t verbally communicate.

“Patients who can’t communicate are three times more likely to experience a preventable adverse event as the rest of the patient population,” Bird said. “So imagine if we can give them the ability to communicate, we should push down the likelihood of that adverse preventable event. And that’s really significant to the hospitals because, as of 2008, all complications arising from preventable adverse events have to be paid by the hospital. They cannot file for reimbursement. They cannot bill the patient. It’s on the hospital. Those are real costs.”

Another big win for Voxello is that the company is being allowed all 25 claims on its patent with the United States Patent and Trademark Office.

“That’s pretty phenomenal,” Bird said. “It’s very unlikely that people wind up getting all of the claims in a situation like that. But in this case we had really good people doing the work, and they got great results.”

The noddle™ was originally developed with Hurtig and a team of UI engineering, law, medicine and business students participating in a two-semester program at UI geared toward given students experience in developing medical devices called the Iowa Medical Innovation Group.

Backed by more than 25 years of research, Voxello’s goal is to create the most innovative and universally adaptable AT devices on the market.  Additionally, it plans to develop a suite of input devices such as microphones, proximity switches, infrared detectors, and pressure switches with proprietary software making them the most valuable and reliable products of their type. Contact the company at http://www.voxello.com/contact/.

UI Ventures, part of the University of Iowa Office of the Vice President for Research and Economic Development (OVPR&ED), offers information and resources to help companies find funding they qualify for, including federal grants, state funding, the UI commercialization GAP fund, loans, angel investment, and venture capital For more information, visit http://uiventures.uiowa.edu/.

The Office of the Vice President for Research and Economic Development provides resources and support to researchers and scholars at the University of Iowa and to businesses across Iowa with the goal of forging new frontiers of discovery and innovation and promoting a culture of creativity that benefits the campus, the state, and the world. More at http://research.uiowa.edu, and on Twitter: @DaretoDiscover.