OtoMetrix Medical Technologies, Inc. is commercializing a ground-breaking, patented, Doppler ultrasound medical device, the OtoStat, to rapidly and accurately diagnose middle ear infections in children and adults. Primary care and emergency room physicians see more than 4 million US cases of Acute Otitis Media annually, leading to 14.8 million patient visits which cost more than $5 Billion per year. Yet clinical studies consistently show error rates in diagnosis averaging 50%.
Otitis Media is the #1 reason for antibiotics prescriptions in children and the #1 cause for surgery in children. Current diagnostic methods are decades old and, critically, cannot distinguish the type of infection behind the tympanic membrane (eardrum).
The handheld OtoStat is designed to quickly and accurately detect both the presence and the type of fluid behind the eardrum in a second or less, providing, for the first time, definitive diagnostic data, leading to increased accuracy, earlier and better treatment, reduced antibiotic use, and reduced healthcare costs.
Middle ear infections (Acute Otitis Media, or AOM) are a major health problem for young children, their caregivers, and the US health care system. Upper respiratory infections are the most common cause of doctor’s visits for children in the US, and AOM is the most common infection for which antibiotics are prescribed for children. AOM can lead to Chronic Otitis Media with Effusion (COME), the most common cause for surgery in childhood. Primary care physicians (Pediatrics, Family Medicine, Emergency Room, Acute Care Clinics and Nurse Practitioners) see more than four million cases of AOM a year in the US alone. In 2007, there were 14.8 million patient visits for Otitis Media. Ten percent of Otitis Media episodes result in chronic infection leading to specialist visits, and a million surgeries for tube placement each year.
Accurate diagnosis is crucial to selecting the proper treatment. However, clinical studies show error rates averaging 50% with decades-old examination equipment such as the hand-held otoscope, a device that is very limited in its capabilities. This incorrect diagnosis in children often leads to over-treatment with antibiotics, which results in resistant organisms and adverse side effects, and to over-referrals by primary care physicians to specialists, resulting in increased healthcare costs to parents, caregivers, and the healthcare system.
OtoMetrix’s OtoStat is under development to employ Doppler ultrasound methods modified for the ear through patented air-coupling and beam-forming technology. Our goal is to provide a device that is comfortable for the child and easy to use for the practitioner, but more importantly, unlike any device currently available, it is able to distinguish not only the presence of fluid behind the eardrum (tympanic membrane), but the type of fluid present.
In our design concept, a Nurse Practitioner, Physician’s Assistant, or minimally-trained technician (as opposed to an experienced specialist) can apply the device and obtain a readout that indicates the presence and type of fluid in the middle ear, which in turn provides objective data for the care provider to interpret. The OtoStat is anticipated to offer many advantages over the subjective interpretation required with the hand-held otoscope and over the tympanometer which is used primarily by audiologists to evaluate the middle ear merely for the presence of fluid. While tympanometry can identify the presence of fluid behind the eardrum, it cannot distinguish among types of fluid, as we believe the OtoStat will. Moreover, tympanometry is more expensive, requires Master’s level training to operate, and is uncomfortable for children as it requires pressurization of the ear canal and restraint for the restless.
It is anticipated that the handheld, easy-to-use OtoStat will become the “thermometer of the ear” – an indispensable device that we believe will be widely adopted by the primary care physician (PCP) community as well as ENTs, audiologists and other relevant practitioners.
In its first commercialization stage, we believe the OtoStat will speed assessment in ERs and primary care clinics. Our goals will be to improve the accuracy of diagnosis and quality of referrals within healthcare systems while reducing examination distress in infants and children. Accomplishing these goals should increase the accuracy of initial diagnoses, reduce needless referrals, reduce unnecessary prescription of antibiotics, decrease drug reactions, and lessen cases of hearing loss and untimely surgeries (tube insertion surgeries account for almost $3 billion in costs annually in the US).
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