Dianyx Innovations, LLC

Two sentence summary:

FDA submission # Q221637 -Dianyx Innovations is developing an intraoral wearable for monitoring compliance and efficacy of oral appliance therapy for sleep apnea, with expanded functionality.
We are pre-FDA, pre-revenue, having an internally validated proof of concept against FDA-approved devices.   Patent(s) pending. 

A 2020 investigation published in the Journal of Clinical Sleep Medicine found that patients with untreated sleep apnea incur a cost of $19,566 per year more than patients in a control group (treated)[1]. This cost is a result of higher in-patient care, emergency visits, readmissions, prescription costs, and other points of service. A 2016 study by Frost and Sullivan found that untreated sleep apnea costs the United States economy nearly 150 billion dollars annually in motor vehicle accidents, workplace accidents, and lost productivity[2]. 

Further, a recent 155-page document published by the Agency for Health Research and Quality (attached) suggests the current “gold standard” of therapy, Continuous Positive Airway Pressure (CPAP), lacks greatly in managing sleep apnea. While alternative therapies continue to enter the market, oral appliance therapy (OAT) is currently covered by the Centers for Medicaid and Medicare Services and recommended as first-line therapy for mild to moderate sleep apnea by the American Academy of Sleep Medicine.  Patients that have used both CPAP and OAT, strongly prefer OAT report wearing their oral appliance three years after beginning therapy (86%)[3].  

Dianyx Innovations is a healthcare technology company dedicated to modernizing the field of oral appliance therapy. Our flexible sensor technology attaches to the oral appliance and monitors compliance and other key indicators of sleep quality.  This data empowers clinicians to better manage chronic diseases like sleep apnea using objective data to drive better health outcomes.  Improved health outcomes reduce overall healthcare utilization and decrease the economic burden of untreated sleep apnea. 

Our highly qualified team offers a tremendous breadth of relevant medical, dental, technical, and business expertise. 

·        Asim Roy, M.D. – board-certified in Sleep Medicine and Neurology 

·        Brandon Canfield D.D.S. American Board of Dental Sleep Medicine 

·        Collin Emerick D.D.S.- American Board of Dental Sleep Medicine 

·        John Cogan Ph.D. Biomedical engineering 

·        Seyed Nabavi Ph.D. Electrical engineer 

·        Robert Kibler – Interim CEO 

Our strategic partners include Respire/Whole You, an oral appliance manufacturer, Galen Data, an FDA-approved cloud management software firm, and Monitor Health, a remote patient monitoring platform with a specific focus on sleep apnea management products. 

[1] Emerson M. Wickwire, PhD1,2; Sarah E. Tom, PhD3; Aparna Vadlamani, MS4 ; Montserrat Diaz-Abad, MD2 ; Liesl M. Cooper, PhD, MBA5 ; Abree M. Johnson, MS, MBA6 ; Steven M. Scharf, MD, PhD2; Jennifer S. Albrecht, PhD4
[2] Frost & SullivanHidden health crisis costing America billions. Underdiagnosing and undertreating obstructive sleep apnea draining the healthcare system. Darien, IL: American Academy of Sleep MedicineAvailable from: http://www.aasmnet.org/sleep-apnea-economic-impact.aspx; 2016.
[3] Bachour P, Bachour A, Kauppi P, Maasilta P, Mäkitie A, Palotie T. Oral appliance in sleep apnea treatment: respiratory and clinical effects and long-term adherence. Sleep Breath. 2016;20(2):805-812. doi:10.1007/s11325-015-1301-0