CARLSBAD, Calif.--(BUSINESS WIRE)--Advanced Brain Monitoring, Inc. announced the worldwide launch of a new product in the treatment of sleep apnea, the Apnea Guard®. Apnea Guard is the first validated temporary oral appliance with clinical equivalence to custom oral appliances for the treatment of snoring and sleep apnea, according to the company. Apnea Guard is cleared by the FDA to be fitted for a patient by a trained healthcare professional and worn for up to 30-nights.
“Apnea Guard addresses the need identified during a $1 mm National Institute of Dental and Craniofacial Research study designed to improve clinical outcomes with oral appliance therapy,” said Dan Levendowski, Principal Investigator. “The scientific evidence strongly supports the use of mandibular advancement for the treatment of sleep apnea. The missing link to wide-spread adoption of custom appliances is access to easy, accurate, and inexpensive identification of patients who will benefit from oral appliance therapy based on a multiple night trial.”
“We developed a patent-pending system that allows clinicians with limited expertise in the delivery of oral appliance therapy to have immediate success. Fitting Apnea Guard is similar to making impressions,” stated Dr. Todd Morgan, co-inventor. “What makes Apnea Guard unique is the capability to transfer the optimized setting directly to a custom oral appliance.” The approach for optimizing the Apnea Guard settings was clinically validated and published in the Journal of Sleep Disorders and Therapy.
In countries such as the United Kingdom, Australia, and Germany, patients without private insurance must pay out-of-pocket for oral appliance therapy. According to Dr. Roy Dookun, President, British Society of Dental Sleep Medicine: “Apnea Guard can provide dentists with an inexpensive solution for obtaining evidence to support the patient’s decision to invest in a custom appliance.”
“Apnea Guard provides sleep medicine physicians in Australia with the option of a temporary treatment that we can objectively assess prior to recommending long-term oral appliance therapy. In our experience to date, this option has been enthusiastically received by our patients,” stated Dr. Andrew Bradbeer.
Dr. Adam Blackman, Chief Medical Director, MedSleep, a leading provider of sleep medicine services across Canada commented: “When Apnea Guard is fitted one-week prior to a laboratory titration study, patients are very close to the optimal adjustment. Sleep technicians may need to make as few as one or two adjustments during the sleep study to confirm the optimal setting for the treating dentist.”
“Apnea Guard was cleared by the FDA so hospital staff could use it to assist with the management of hypoxemia and sleep apnea post-operatively,” stated Dr. Philip Westbrook, Chief Medical Officer, Advanced Brain Monitoring, and Past-President, American Academy of Sleep Medicine. “For patients suspected of having sleep apnea, it provides a therapeutic safety-net during their hospital stay and after discharge while on narcotic pain medications. The 30-night ‘window for use’ provides sufficient time for the patient to return for a post-surgery sleep study.”
Dr. Minoru Furuhata, Board Director, Japanese Academy of Dental Sleep Medicine explained: “In Japan where medical reimbursement is typically limited to non-adjustable appliances, Apnea Guard can be used to determine the optimal setting prior to fabrication of the mono-block.”
“Because Apnea Guard has no metal components and controls both vertical and protrusive adjustment, it can be used in MRI imaging studies to better understand the response of the airway to mandibular repositioning,” stated Dr. Miche DeMeyer, Researcher at University Hospital of Ghent in Belgium, and Past-President, European Society of Dental Sleep Medicine.
Apnea Guard will be introduced at the American Academy of Sleep Medicine and American Academy of Dental Sleep Medicine conferences June 6-13, 2012 in Boston, MA.