Ultrasound-based otoscopy for rapid, objective middle ear infection assessment.
OtoNexus is developing an ultrasound otoscope that delivers objective middle-ear assessment in seconds. By reducing reliance on subjective visual inspection, the system is intended to support more consistent evaluation of otitis media and better targeted antibiotic decisions. The ultrasound sensor is miniaturized within the ear speculum tip to enable use in routine clinical workflows.
Certainty in Every Scan
This new otitis media medical device resembles a traditional otoscope and can fit in a lab coat pocket, but that is where the similarities end. With the advanced ultrasound otoscope, clinicians simply push a button to get the results they need. A proprietary algorithm analyzes data to identify the presence and type of fluid within seconds. Surgical correlation studies and microbiota analyses have validated the accuracy of these results.
This definitive data has never been available without an invasive procedure. Integrating this technology will enable novice and expert clinicians to obtain consistent quantitative measurements and reduce time to diagnosis by simplifying the testing process.
Key Features:
OtoNexus Medical Technologies ultrasound otoscope for accurate detection of middle ear infections (otitis media)
Instant Results: The OtoNexus ultrasound otoscope delivers data within seconds, allowing for immediate clinical decisions.
Ease of Use: Designed for physicians, nurse practitioners, and physician assistants, the device is straightforward and user-friendly, and integrates into existing clinical workflows with minimal training. Measurement is automated, and the device initiates measurement when conditions are optimal.
Disposable Tips: Ensure hygiene and generate recurring revenue with one-use-per-patient tips.
Universal-Sized Speculum: The ear speculum fits patients of all sizes (newborn to 18 years of age) and simplifies the examination process and inventory management.
Accurate Detection: Capable of detecting middle ear effusion and differentiating between viral and bacterial infections, leading to more precise treatments.
Direct Integration with EMRs: Exam results, images, and videos are easily transferred to electronic medical records, saving time and improving clinical workflows. This integration saves valuable time, facilitates longitudinal patient tracking, and simplifies specialist referrals.
Product Development Achievements:
Patented Technology: Our proprietary application of through-air ultrasound, miniaturized to fit within the tip of an ear speculum, is patented, providing a competitive edge in the market.
Clinical Validation: We have conducted successful clinical studies demonstrating the ultrasound otoscope's high accuracy and reliability, validating its effectiveness.
Strategic Partnerships: We have established collaborations with leading healthcare institutions and organizations to further our mission and enhance our market reach.
Industry Recognition:
OtoNexus was selected for the elite FDA Safer Technologies Program (STeP) in December of 2023. STeP is a pioneering initiative introduced by the FDA to identify and expedite the development and review of innovative medical devices that offer a significant advantage over all currently available options. Devices selected for the program provide radical improvements in patient care and patient safety. STeP aims to provide patients with more timely access to these medical devices by providing STeP awardees expedited development and review, and interactive and timely communications, including sprint discussions, enhanced regulatory support, real-time feedback and direct advice, and other support. To qualify, the product must offer a significant advantage over currently available options. The evaluation process for the program requires comprehensive due diligence by the FDA to ensure the technology meets the strict, extensive criteria for the STeP program. This is a significant validation of our unique technology and the need for a superior otitis media medical device.
Our Focus
Learn more about our mission to improve the detection and treatment of middle ear infections. By choosing OtoNexus, you support a company dedicated to significantly impacting pediatric patient care and the broader healthcare system. With a strong IP portfolio, a robust recurring revenue stream, and a blue ocean market space, OtoNexus is poised for success as a medtech innovator. For investor information, Find out more here.
Together, we can change the future of pediatric healthcare.