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Non-Invasive Oropharynx Appliance to Maintain Airway Patency

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HL150933-01
Agency Tracking Number: R41HL150933
Amount: $299,743.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NHLBI
Solicitation Number: PA18-575
Solicitation Year: 2018
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-09-05
Award End Date (Contract End Date): 2021-08-31
Small Business Information
Shaker Heights, OH 44122-3115
United States
DUNS: 114366626
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (440) 476-7522
Business Contact
Phone: (440) 476-7522
Research Institution
CLEVELAND, OH 44106-1712
United States

 Nonprofit College or University

Obstructive Sleep Apnea (OSA) is a serious condition that affects about 4% of the
population. During sleep, the tongue can fall into the oropharynx and occlude the airways
Patients with this condition suffer many instances of apneas (complete cessation of
breathing) and hypopneas (period of abnormally low respiratory rate). The apnea-
hypopnea index (AHI) gives the number of such episodes per hour and indicates the
severity of this condition (AHIandlt;5 is normal while AHIandgt;30 is severe). Abnormal AHIs are
associated with significant decrease of oxygen saturation leading to severe co-morbidities
such as stroke, high blood pressure, diabetes, epilepsy and cardiac arrhythmia. The cost
to the society of OSA-related illnesses ranges between 60 and 160 billion dollars
annually. The current standard-of-care is the continuous positive airway pressure (CPAP)
device which has a low compliance of around (50%). There are also other therapeutic
modalities either invasive or non-invasive but none are very effective. There is at present
no non-invasive solution that can ensure both patient compliance and efficacy. A new
start-up, ANÉMed proposes to develop and test a novel non-invasive oropharynx
appliance (OPA) capable of providing both efficacy and compliance. This new appliance
addresses the problem of OSA by placing a tongue retaining device directly into the
oropharynx preventing the tongue from obstructing the airways. The new design can
prevent obstruction without causing a gag reflex and still allowing swallowing. It is
designed to be more effective that other oral appliances such as the mandibular
advancement device. If successful, the OPA could become the first line of defense
against OSA for over 25 million Americans with a diagnosis of OSA.Narrative:
Millions of Americans suffer from obstructive sleep apnea, a condition whereby the tongue
obstructs the airway during sleep. Commercially available devices to treat this condition have
either low compliance or efficacy. The proposed experiments will test a novel non-invasive oral
appliance with significant potential to effectively treat this condition.

* Information listed above is at the time of submission. *

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