Addressing a Critical Unmet Need

Middle ear infections are common, particularly in young children, and accurate diagnosis can be challenging. The OtoNexus ultrasound otoscope addresses a significant unmet need in pediatric healthcare by providing instant, non-invasive, and accurate detection of otitis media. Clinicians lack the tools to objectively and accurately test for middle ear infections. The technology used to examine the ear remains subjective and has not changed in decades. The result is often misdiagnosis of middle ear infections and unnecessary antibiotic prescriptions or specialist referrals. By providing clear, objective data, the OtoNexus ultrasound otoscope helps clinicians make accurate diagnoses, reducing the incidence of misdiagnoses and unnecessary treatments.

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.

Technology Development Objectives

The OtoNexus ultrasound otoscope is being designed to automatically detect appropriate measurement conditions, acquire and analyze through-air ultrasound signals, and provide objective information within seconds during the patient visit. The planned system includes a single-use disposable tip incorporating the ultrasound sensor, a universal-sized speculum designed for patients from newborns to adults, and straightforward operation requiring minimal user training. Future connectivity is intended to enable the transfer of examination results to compatible electronic medical record systems. Final specifications and performance claims will be provided after FDA review.

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.

Results 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

A universal-sized ear speculum is being designed for use across the patient population, from newborns to adults, 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 is being designed to support integration with electronic medical records, enabling examination information to become part of the patient’s longitudinal clinical record.

FDA STeP and Regulatory Strategy:

OtoNexus was selected for the elite FDA Safer Technologies Program (STeP)in December of 2023. STeP is a pioneering FDA initiative to identify and expedite the development and review of innovative medical devices that offer a significant advantage over currently available options. Devices selected for the program provide radical improvements in patient care and patient safety. The evaluation process for the program requires the FDA to conduct comprehensive due diligence to ensure the technology meets the STeP program's strict, extensive criteria.

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 selection is a program designation and does not represent clearance or approval. The device remains in development, and regulatory outcomes depend on submission content and FDA review.

Product Development Achievements:

• Patented Technology: Our unique proprietary application of through-air ultrasound technology, which has been miniaturized to fit into the tip of an ear speculum. OtoNexus has secured 110 patents on this unique technology, ensuring a competitive edge in the market.

• Clinical Validation: We have conducted highly successful clinical studies demonstrating the exceptional accuracy and reliability of the ultrasound otoscope and validating its effectiveness.

• Strategic Partnerships: We have established collaborations with leading Children’s Hospitals, healthcare institutions, and organizations to ensure the system fits seamlessly into clinical workflow.

Market Opportunity

Middle ear infections are the leading cause of antibiotic prescriptions and surgeries in children, resulting in significant healthcare costs and patient discomfort. The OtoNexus device addresses these challenges by enabling accurate, rapid, non-invasive detection of middle ear infections, improving patient care, and reducing healthcare costs.

• 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.

A Personal Message from Caitlin Cameron, Chair and CEO

OtoNexus Medical Technologies is in the late stages of developing the world’s first medical device to instantly and accurately diagnose middle ear infections (Otitis Media).

Diagnostic uncertainty is reduced by accurately identifying the type of infection and other conditions, enabling pediatricians and parents to confidently determine the need for antibiotic use. This can significantly reduce unnecessary antibiotic use and its long-term consequences.

Our cost-effective advanced ultrasound otoscope provides results in seconds and is easy to use for physicians and non-physician personnel worldwide. Definitive, objective data will lead to improved patient outcomes, faster, better treatment, reduced antibiotic use, and significantly lower healthcare costs.

We fill a significant gap and provide positive incentives to all parties involved — pediatricians, parents, insurance carriers, and medical societies — all of whom understand the benefits of improved patient outcomes, reduced costs, and antimicrobial stewardship.

This revolutionary medical device will reinvent the ear exam.

I hope you will join us.

Caitlin Cameron, Chair and CEO

OtoNexus Medical Technologies

Learn More About Our Investment Opportunity

OtoNexus is advancing 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.

Qualified investors are invited to complete the form below to request additional information about the company, development program, and investment opportunity.

The OtoNexus ultrasound otoscope is investigational, has not been cleared by the FDA, and is not currently available for commercial sale.

Industry Recognition

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

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.