PhotoniCare's OtoSight Demonstrates More Accurate Diagnosis and a 50 Percent Reduction in Antibiotic Usage for Pediatric Ear Infections in Large Randomized Controlled Trial

Yahoo

19-05-2025

DURHAM, N.C. and GRAND RAPIDS, Mich., May 19, 2025 (GLOBE NEWSWIRE) -- PhotoniCare Inc., a medical device company dedicated to delivering innovation to frontline care that demonstrably enhances patient outcomes, is pleased to announce its progress in the diagnosis and treatment of pediatric ear infections that affect more than 80 percent of children by age three, account for millions of visits to the pediatrician each year, and are the leading cause of antibiotic use in children. The interim results from the OTO-MATIC randomized controlled trial (RCT) demonstrate PhotoniCare's OtoSight™ Middle Ear Scope significantly reduces the number of antibiotic prescriptions written for pediatric patients presenting to a primary care office with ear-related complaints as well as a shift toward more singular treatment decisions, reducing reliance on combination therapies. The multicenter, real-world effectiveness study showed a 50 percent reduction in the odds of antibiotic prescribing when clinicians used PhotoniCare's Optical Coherence Tomography (OCT) otoscope, compared to the standard of care (SOC) with a traditional otoscope. 83 percent of target recruitment was included in the interim analysis, which was sufficiently powered. The results of the study, Otitis Treatment with OtoSight™ – Modification of Antibiotic Treatment Intervention in Children (OTO-MATIC), have been published via open access in the International Journal of Pediatric Otorhinolaryngology.
Commenting on the results of the study, Ryan Shelton, Ph.D., CEO and Co-Founder of PhotoniCare said, 'Ear infections are not only the most common reason children receive antibiotics—they're also a leading cause of surgery and hearing loss in pediatrics. The OtoSight Middle Ear Scope leverages OCT imaging to visualize through the eardrum and determine the presence or absence of fluid in the middle ear as well as characterize the type of fluid, even in the presence of earwax. These interim RCT results validate the power of the technology to improve diagnostic accuracy, support antibiotic stewardship, and ultimately help providers deliver better care for a condition that affects the vast majority of children.'
Dr. April Zambelli-Weiner, M.P.H., President and CEO of TTi Health Research & Economics who serves as Principal Investigator and Contract Research Organization CRO for the study added, 'Our research reveals that the OtoSight device, through its advanced OCT imaging, can significantly curb unnecessary antibiotic use. It does this by providing clinicians with a clearer picture of middle ear conditions, leading to more accurate diagnoses and a 50 percent decrease in antibiotic prescriptions. It streamlines treatment approaches, encouraging single therapies over multimodal treatments. These findings, replicated across our entire study cohort, suggest a promising future for this technology in enhancing both diagnostic accuracy and antibiotic stewardship.'
Children with ear-related complaints are misdiagnosed up to 50 percent of the time using the current gold standard, examination via otoscope. 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.
OtoSight is the first FDA cleared device for middle-ear visualization, offering unique CPT codes to capture the procedure. OtoSight has significant commercial traction, validating product-market fit in pediatrics, family practices and ENT. In addition to the current large RCT, the company has previously published multiple peer-reviewed manuscripts demonstrating the utility of the device to help drive continued reimbursement and market adoption.
About PhotoniCare Founded in 2013, PhotoniCare's mission is to improve clinical outcomes and serve unmet patient and 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+ percent 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 2025 NextMed Health MEDy Award, 2021 Northwest Arkansas Tech Summit Pitch Competition, 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 and took first place at the 7th Annual Insight Product Development 2019 HealthTECH Startup Competition. PhotoniCare has received more than $6 million in support from the National Institutes of Health, most recently a Phase SBIR II award for work in artificial intelligence. In 2015, PhotoniCare was the winner of a grant from the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), an FDA-funded consortium led by Children's National Hospital. More information can be found at https://photoni.care/.
Media Contact:David Gutierrez, Dresner Corporate Services for PhotoniCare, [phone], [e-mail]