The transferred technology is a non-invasive, intensive, swallowing retraining device that combines sensory stimulation with motor retraining to rehabilitate swallow function, initially targeted for dysphagia patients. Dysphagia is a common disorder that creates difficulty swallowing. Patients at risk of choking on fluid or food face a risk of life-threatening aspiration pneumonia and may need to be fed through a tube. Dysphagia may occur as a result of stroke, brain injury, tumor removal, or neurodegenerative disease with associated high medical care costs as well as decreased quality of life and social opportunity. The prevalence of dysphagia is likely to increase in the U.S. as the population ages. 

The overall purpose of the technology is to provide a new system for daily self-training of swallowing that is less costly and potentially more effective than options currently available. The device provides triggering of the reflexive component of swallowing synchronous with volitional retraining throughout the day in a patient’s own environment. This can augment or replace current approaches to rehabilitation that depend upon the patient having access to speech pathologists for a limited intervention of only a few hours a week. 

Following discussions with multiple companies and a CRADA for comparison to an implanted system, the technology was licensed to Passy-Muir, Inc., a small, privately owned company based in Irvine, California with a worldwide reputation for the delivery of high quality medical devices for voice and swallowing. Its product line includes non-mechanical swallowing and speaking valves for adults and children. Passy-Muir was granted rights to the technology under an exclusive license with the National Institutes of Health. 

The nominees were intricately involved in the transfer process. Christy L. Ludlow, Ph.D., formerly at the Laryngeal and Speech Section of the NINDS at NIH, was the main inventor of the technology. Dr. Ludlow has extensive knowledge and experience studying vibratory stimulation as a trigger for swallowing. Laurie Arrants, M.S., the Technology Development Coordinator for NINDS, was a steadfast champion of the technology within NINDS and for years advised Dr. Ludlow about positioning the device for commercialization and marketed the technology. Heather Gunas, J.D., M.P.H., a Technology Transfer Specialist at NIH, negotiated numerous, related agreements including a CRADA; she also conducted a direct marketing campaign to multiple companies which included Passy-Muir. Dr. Ludlow, supported by Ms. Gunas and Arrants, worked diligently to show Passy-Muir that its ongoing distribution, training programs, and target patient population were suited perfectly for the device. Passy-Muir then negotiated an exclusive license with Michael Shmilovich, J.D., and Susan Ano, Ph.D., both from the Division of Technology Development and Transfer, OTT, NIH. The two worked with the company to develop realistic milestones based on the developmental and regulatory pathway required for marketing. 

Awardees

NIH - National Institute of Neurological Disorders and Stroke 

• Dr. Christy Ludlow
• Heather Gunas 
• Laurie Arrants

NIH - Office of Technology Transfer

• Michael Shmilovich
• Dr. Susan Ano