Reducing Diagnostic Uncertainty
In Middle Ear Infection Assessment
OtoNexus Medical Technologies is developing an investigational AI-assisted ultrasound otoscope designed to provide objective information about middle ear conditions during routine ear examinations.
The ultrasound otoscope is the initial application of a proprietary through-air ultrasound platform. OtoNexus is advancing the engineering, clinical, and regulatory work required to evaluate the technology and prepare it for future FDA review.
Investigational device. Not cleared by the FDA. Not available for commercial sale.
Company Highlights:
Differentiated through-air ultrasound technology designed for middle ear assessment
AI-assisted signal analysis intended to provide objective information during the ear examination
Broad Intellectual-property portfolio supporting the technology platform and potential applications
FDA Safer Technologies Program participation
Ongoing clinical evidence-generation program
Planned capital-equipment and recurring-consumable business model
Platform potential extending beyond the initial middle-ear application
Intellectual Property Protection
OtoNexus has developed an intellectual-property portfolio covering applications of its proprietary through-air ultrasound technology, miniaturized ultrasound sensing, and related medical and industrial applications.
Additional information about the company's intellectual-property portfolio is available to qualified investors.
Addressing a Common Diagnostic Challenge
Middle-ear infections are among the most common reasons young children receive medical care. Evaluating the middle ear typically relies heavily on visual examination of the eardrum, but interpretation can vary based on clinician experience, patient anatomy, and exam conditions.
OtoNexus is developing an ultrasound otoscope to add objective information to routine ear exams. The goal is to help clinicians assess middle-ear conditions with greater confidence and support more informed treatment decisions, including responsible antibiotic use.
Clinical Research Program
OtoNexus is working with clinical research sites to acquire clinical evidence for future regulatory review. The research program is designed to assess performance across relevant patients and clinical settings. We will add additional information about completed and ongoing studies, participating sites, enrollment, and scientific presentations as those details become appropriate for public disclosure.
The OtoNexus Difference
A differentiated sensing approach
OtoNexus is applying through-air ultrasound to collect information from the middle ear during an otoscopic examination.
Objective information at the point of care
The platform is being designed to supplement visual examination with an automated ultrasound measurement.
Designed for routine clinical workflow
The planned system combines reusable capital equipment with a disposable patient-contact component and is being developed for use during a routine patient visit.
Technology Development Objectives
OtoNexus is developing its investigational ultrasound otoscope to integrate objective through-air ultrasound information into a familiar ear examination. Current development objectives include automated signal acquisition and analysis, rapid information delivery during the patient visit, straightforward operation, a single-use patient-contact component, and future clinical information connectivity.
Final device specifications and performance claims will be established after development is complete and applicable regulatory review is completed.
Objective middle-ear assessment
The system is designed to collect through-air ultrasound signals and use automated analysis to provide objective information about middle ear conditions.
Information during the patient visit
The device is designed to complete measurements and provide information within seconds, supporting clinical decision-making during routine examinations.
Automated, straightforward operation
The system is designed to automate signal acquisition and analysis, initiate measurement when appropriate conditions are detected, and require minimal user training.
Broad pediatric compatibility
The ear speculum is being developed to support a broad range of patient anatomies, with the goal of simplifying clinical use and reducing the need to manage multiple speculum sizes.
Disposable patient-contact component
The planned system includes a patented, single-use disposable tip designed to support hygienic operation and create a recurring consumable component within the business model.
Clinical information connectivity
The device will support integration with electronic medical records, enabling examination information to become part of the patient’s longitudinal clinical record.
Development Priorities
OtoNexus’s current development priorities include:
Advancing product design and verification activities
Continuing clinical evidence generation
Preparing for future regulatory interactions and submissions
Developing manufacturing and commercialization readiness
Expanding selected clinical, research, and strategic collaborations
FDA STeP and Regulatory Strategy:
OtoNexus was selected for the FDA Safer Technologies Program (STeP) in December 2023. STeP provides opportunities for increased interaction with the FDA during device development and regulatory review.
What STeP provides (in practice)
A structured framework for early and ongoing engagement with the FDA during development
Opportunities to align on evidence expectations, study design considerations, and key submission requirements
More predictable communication pathways as the program advances toward submission and review
Why it matters to execution
Supports earlier clarity on regulatory expectations and development priorities
Can reduce iteration cycles by addressing key questions earlier in the program lifecycle
Helps focus resources on the data and documentation needed to support submission readiness
Important note
STeP designation does not represent FDA clearance or approval. The OtoNexus ultrasound otoscope remains investigational and is not available for commercial sale.
Frequently Asked Questions About Our Technology
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Evaluation of suspected middle ear infection can be challenging because clinicians must assess conditions behind the eardrum using visual findings, symptoms and other clinical information. OtoNexus is developing technology intended to add objective ultrasound information to the routine ear examination and reduce diagnostic uncertainty.
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The investigational OtoNexus ultrasound otoscope applies proprietary through-air ultrasound technology during an ear examination. A miniaturized ultrasound sensor is incorporated into the disposable ear-speculum tip, and AI-assisted algorithms are being developed to analyze the collected signals and provide objective information about middle ear conditions.
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OtoNexus is advancing the engineering, clinical and regulatory activities required to evaluate the investigational system and prepare it for future FDA review. Current work includes product development, design verification and validation, clinical evidence generation, regulatory planning and commercialization readiness.
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No. The OtoNexus ultrasound otoscope is investigational, has not been cleared by the FDA and is not currently available for commercial sale. The technology was selected for the FDA Safer Technologies Program, or STeP, in December 2023. STeP participation provides opportunities for increased interaction with the FDA during development and review, but it does not represent FDA clearance or approval.
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OtoNexus is pursuing a capital-equipment and recurring-consumable model. The planned system consists of a reusable ultrasound otoscope and a patented, single-use disposable tip containing the ultrasound sensor. Recurring tip use is expected to scale with the installed device base and examination volume.
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The technology is initially being developed for healthcare professionals who evaluate patients with suspected middle ear conditions, including pediatricians, family medicine clinicians, urgent care clinicians and otolaryngologists. These settings represent a substantial volume of ear examinations and a significant need for more objective information at the point of care.
A Significant Opportunity to Improve the Ear Examination
Clinicians perform ear examinations across pediatric, primary care, urgent care, emergency, and specialty settings. Yet clinicians have limited access to objective middle-ear information during routine examinations.
OtoNexus is building a handheld, AI-assisted ultrasound otoscope that integrates objective middle-ear information into a familiar clinical workflow. The company’s initial focus is middle-ear assessment, with the broader objective of advancing its proprietary through-air ultrasound platform for additional applications over time.
Otitis media creates a substantial clinical and economic burden.
Assessment can be challenging with existing examination methods.
Pediatric, family medicine, urgent care, and ENT settings represent potential users.
Antibiotic stewardship creates a strategic need for more informed treatment decisions.
The planned device-and-consumable model creates potential recurring revenue.
Intellectual Property Protection
OtoNexus has developed an intellectual-property portfolio covering applications of its proprietary through-air ultrasound technology, miniaturized ultrasound sensing, and related medical and industrial applications.
Additional information about the company's intellectual-property portfolio is available to qualified investors.
A Message from Caitlin Cameron, Chair and CEO
Caitlin Cameron, Chair and CEO, OtoNexus Medical Technologies
Middle-ear disease is common, particularly among young children, yet routine ear examinations still rely heavily on visual interpretation. This can leave clinicians without the objective information they need when making treatment decisions.
OtoNexus is developing an ultrasound otoscope intended to address that challenge. Our proprietary through-air ultrasound technology provides objective information about the middle ear during a familiar ear examination. Our goal is to help reduce diagnostic uncertainty, support more informed treatment decisions, and contribute to responsible antibiotic use.
We are advancing the technology through product development, clinical evidence generation, and regulatory planning. At the same time, we continue to explore the broader potential of our through-air ultrasound platform across medical and non-medical applications.
We welcome inquiries from individuals and organizations interested in learning more about OtoNexus, its technology platform, and its development program.
Caitlin Cameron
Chair and Chief Executive Officer
OtoNexus Medical Technologies
Learn More About OtoNexus
OtoNexus is building an investigational AI-assisted ultrasound otoscope designed to provide objective information about middle ear conditions during routine ear examinations. The development program is supported by proprietary through-air ultrasound technology, an established intellectual property portfolio, participation in the FDA Safer Technologies Program, and ongoing clinical research.
The company is pursuing a planned capital-equipment and recurring-consumable business model, initially focused on pediatric, family medicine, urgent care, and otolaryngology settings. Current investment will support the clinical, regulatory, engineering, and commercialization-readiness milestones required to advance the technology toward future FDA review and market introduction.
OtoNexus welcomes inquiries from qualified investors interested in learning more about our technology platform, development program, planned business model, and future growth opportunities.
The OtoNexus ultrasound otoscope is investigational, has not been cleared by the FDA, and is not currently available for commercial sale.
Industry Recognition
Industry recognition awards
In addition, OtoNexus Medical Technologies is honored to have received awards and recognition from Keiretsu Capital (Most Valued Company), Keiretsu Forum MidAtlantic (Most Valued Company), Keiretsu Forum Northwest (Most Valued Company), Red Herring (Top 100 North America), Angel Capital Association (Most Investable Company), Puget Sound Business Journal (Washington’s 100 Best Workplaces), MedTech Outlook (Top 10 Infection Control Solution Providers), MedTech Strategist (Startups to Watch), Silicon Review (Innovative Companies to Watch) and Women Corporate Directors (Winner Launch Zone).
OtoNexus is also proud to be supported by Golden Seeds, an early-stage angel investment firm that champions and funds women-led startups.
Support and Funding
Supporting Organizations OtoNexus Medical Technologies
OtoNexus Medical Technologies has received grants and/or support from the following institutions and groups: National Institutes of Health, National Science Foundation, State of Washington, Life Sciences Discovery Fund, Southwest Pediatric Device Consortium, Philadelphia Pediatric Medical Device Consortium, MedTech Innovator, Advanced Medical Technology Association, Future in Review, Consortium for Technology and Innovation in Pediatrics, FDA Safer Technologies Program.