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Champaign, IL 61820
Champaign, IL – PhotoniCare, Inc., a company dedicated to revolutionizing healthcare by providing healthcare providers with better diagnostic tools, today announced that it is rebranding its middle ear scope to OtoSight™ Middle Ear Scope (formerly TOMi™ Scope). In preparation for the 2021 commercial launch, the OtoSight™ Middle Ear Scope brand name is well-positioned to convey the product’s unique ability to non-invasively see through the eardrum and assess the middle ear space. Using optical coherence tomography (OCT) high resolution depth imaging, OtoSight™ Middle Ear Scope helps to determine the presence or absence of fluid in the middle ear and to characterize the fluid type, even in the presence of significant ear wax.
Data published in January 2020 shows that the technology used in OtoSight Middle Ear Scope is 90.6% accurate in the detection of Middle Ear Effusion.[i] “Current tools can only provide a view of the surface of the eardrum, forcing healthcare providers to make an assessment with very limited information, or to employ invasive surgical procedures to accurately identify middle ear pathologies,” said Diego Preciado, M.D., Ph.D. of the Children’s National Hospital in Washington, D.C., a lead investigator for clinical studies of the device. “OtoSight™ Middle Ear Scope’s advanced light-based technology could dramatically alter the way children with ear problems are evaluated, enhancing our ability to inform optimal treatments.”
Middle ear infections are the leading cause of hearing loss, surgery and antibiotic use, especially in children. Affecting more than 80% of children, they are misdiagnosed up to 50% of the time using the current gold standard, examination via otoscope.[ii] Children can suffer from recurring ear infections for six to 12 months before they are referred to an ENT specialist, and are often prescribed increasingly potent antibiotics during this time. Often, the endpoint of the disease is insertion of tympanostomy tubes in the eardrum. More than one million tube surgeries are performed in the U.S. alone every year.
“Clinicians seeking to be more accurate and confident in their assessment of middle ear fluid and fluid type will find this new technology using light wave detection very helpful,” said Michael Pichichero, M.D., Director of the Rochester General Hospital Research Institute and Research Professor at the Rochester Institute of Technology in New York. “The fact that it works well even in the presence of significant wax build-up is of great value. Wax continues to be a huge problem in middle ear diagnosis.”
Founded in 2013, PhotoniCare’s mission is to improve clinical outcomes and serve unmet patient & provider needs by translating novel light-based technologies into objective medical practice, starting with the OtoSight™ Middle Ear Scope. The FDA-cleared OtoSight™ Middle Ear Scope was developed for healthcare providers seeking a superior solution for pediatric middle ear issues. With remarkable 90+% reader accuracy in determining the presence or absence of fluid in the middle ear, the OtoSight™ Middle Ear Scope eliminates subjectivity and speculation by providing patients with a non-invasive and comprehensive assessment of middle ear fluid, even in the presence of significant earwax.
PhotoniCare has been recognized by numerous organizations, winning the 2020 SPIE PRISM award for medical technologies, the 2018 MedTech Innovator Execution Award, and the 2018 AdvaMed Accel Virginia Shimer Rybski Memorial Award. The company was also a member of the 2016 Dreamit Ventures accelerator program. PhotoniCare has received more than $6 million in support from the National Institutes of Health, most recently a Phase II SBIR award for work in artificial intelligence.
[i] Preciado D, Nolan RM, Joshi R, Krakovsky GM, Zhang A, Pudik NA, Kumar NK, Shelton RL, Boppart SA, Bauman NM. Otitis media middle ear effusion identification and characterization using an optical coherence tomography otoscope. Otolaryngol Head Neck Surg, 2020.
[ii] Pichichero, Michael E., Poole, Michael D. Assessing Diagnostic Accuracy and Tympanocentesis Skills in the Management of Otitis Media. Arch. Pediatr. Adolesc. Med. 2001. 155(10):1137-1142. doi:10.1001/archpedi.155.10.1137
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