OtoNexus Medical Technologies Inc.

What OtoNexus Medical Technologies Inc. does

OtoNexus Medical Technologies Inc. is a pre-revenue, venture-backed medical device company developing the Novoscope, a handheld ultrasound otoscope that miniaturizes a through-air ultrasound sensor into the tip of a disposable ear speculum and applies a proprietary algorithm to detect middle ear effusion and differentiate bacterial from viral infections in approximately two seconds. The technology is housed in a point-of-care device intended to replace subjective conventional otoscopy for frontline pediatric and primary-care decision-making, with direct EMR integration to transfer exam results, images, and video into patient records. The company was founded by Dr. George Gates, a practicing ENT surgeon, and Dr. Mark Moehring, an ultrasound systems expert and inventor of 16 issued ultrasound patents, and is led by Chair and CEO Caitlin Cameron with a leadership team drawn from Philips Healthcare, Fujifilm SonoSite, GE Healthcare, and Verathon.

The company protects its platform with more than 110 granted patents covering the through-air ultrasound modality, transducer design, and proprietary classification algorithm, and was selected for the FDA Safer Technologies Program (STeP) in December 2023, providing structured FDA engagement and an expedited review pathway. The commercial model is razor/razorblade: the Novoscope is sold or placed as durable capital equipment in clinics, while each exam consumes a single-use disposable tip, creating recurring consumables revenue that scales with installed base utilization. Target customers are primary care physicians, pediatricians, nurse practitioners, and physician assistants, with secondary segments in children's hospitals, pediatric emergency departments, and payers seeking to reduce unnecessary antibiotic prescriptions and downstream costs from misdiagnosed otitis media.

OtoNexus is headquartered near Seattle, Washington, is classified as a Micro Company (11-50 employees), and has raised approximately $13 million in equity from Keiretsu Capital and Keiretsu Forum members since inception, supplemented by non-dilutive SBIR grants from NIH ($1.15 million Fast-Track in 2017) and NSF (Phase I, Phase II, and Phase IIB). The company has built clinical and development partnerships with Fraunhofer IPMS for transducer co-development, with Mayo Clinic and Mary Bridge Children's Hospital for clinical validation, and is a member of three pediatric device consortia (CTIP, Southwest Pediatric Device Consortium, Philadelphia Pediatric Medical Device Consortium). Products are not yet commercially available, and the company is positioning itself for market entry pending FDA clearance.

Name

OtoNexus Medical Technologies Inc.

Legal name

OtoNexus Medical Technologies Inc.

Website

https://otonexus.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

OtoNexus Medical Technologies is a pre-revenue medical device company developing the Novoscope, an AI-driven ultrasound otoscope that detects bacterial middle ear infections in pediatric and primary care settings through a razor/razorblade model combining a capital device with single-use disposable tips.

Ownership category

akta.pro rank

Product category

Diagnostic Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Otology & Neurotology (Ear/Hearing/Balance) (HLAKAMAC)

Keywords

• Medical device diagnostics
• Ultrasound otoscope technology
• Ear infection detection
• Pediatric medical devices
• Antibiotic stewardship solutions

Headquarters

HQ city

Bellevue

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Supply Chain, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Ultrasound Otoscope Device Sales: The ultrasound otoscope is sold (or placed) as durable capital equipment, creating an installed base in clinics. The device generates upfront revenue upon sale or placement, with potential for service and support contracts.
2. Single-Use Disposable Tips (Razor/Razorblade): Each exam uses a single-use disposable tip which supports infection control and generates repeat purchase volume tied directly to utilization. As adoption grows and exam volume increases, consumable demand scales with the installed base, creating recurring revenue alongside device sales.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

OtoNexus is developing the Novoscope, a handheld ultrasound otoscope that miniaturizes through-air ultrasound sensors into the ear speculum tip to detect middle ear fluid and differentiate bacterial from viral infections in approximately 2 seconds at the point of care. The product combines a capital device (the Novoscope) with single-use disposable speculum tips in a razor/razorblade model, generating recurring consumables revenue alongside device sales. The device integrates with electronic medical records (EMR) and is targeted at pediatricians, primary care physicians, nurse practitioners, and physician assistants diagnosing middle ear infections.

Product overview

OtoNexus Medical Technologies Inc. is developing the Novoscope ultrasound otoscope as its core medical device product—a handheld, ultrasound-based diagnostic tool that fits in a lab coat pocket and delivers instant, objective middle-ear assessment at the point of care. The company employs a razor/razorblade commercial model, combining capital device placement (the Novoscope) with recurring consumables revenue from single-use disposable tips. The Novoscope is designed for use by physicians, nurse practitioners, and physician assistants in frontline settings, with results delivered in seconds through a simplified one-button workflow. The device integrates directly with electronic medical records for seamless data transfer.

Differentiator

Problem solved

Functional benefit

Brands

• Novoscope: The ultrasound otoscope product developed by OtoNexus for instant, accurate assessment of middle ear infections using miniaturized ultrasound sensor embedded in ear speculum tip

Products and services

• Novoscope Ultrasound Otoscope A handheld point-of-care ultrasound otoscope that miniaturizes a through-air ultrasound sensor within the ear speculum tip to detect middle ear effusion and characterize infection type, supporting differentiation of bacterial from viral infections in approximately 2 seconds. Designed for physicians, nurse practitioners, and physician assistants in frontline pediatric and primary care settings, with one-button workflow and direct EMR integration. Sold or placed as capital equipment to healthcare clinics under a razor/razorblade model.
• Single-Use Disposable Speculum Tips Disposable ear speculum tips designed for one-time per-patient use with the Novoscope ultrasound otoscope. These single-use tips ensure infection control compliance and generate recurring consumables revenue tied directly to device utilization as part of OtoNexus's razor/razorblade commercial model. The tips are universal-sized to fit patients from newborn to 18 years of age.

Quantifiable outcome

• Results delivered in 2 seconds compared to traditional otoscopy subjective assessment
• +2 more outcomes

Named customers2 records

Segments4 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

AI capability2 records

Feature6 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• Fraunhofer IPMS (Dresden, Germany)coreTechnology or Integration · 12 November 2018OtoNexus partnered with Fraunhofer IPMS to continue the development of ultrasound transducers. Fraunhofer IPMS is a renowned German research organization specializing in microelectronics and microsystems technology.
• Consortium for Technology & Innovation in Pediatrics (CTIP)coreStrategic or Co-development PartnerAccepted into prestigious pediatric medical device accelerator based at Lurie Children's Hospital and Children's Hospital Los Angeles. CTIP is funded by FDA Pediatric Device Consortia grant program and provides access to clinical, engineering, regulatory, and commercial experts across 25 organizations in 8 states.
• MedTech InnovatorcoreStrategic or Co-development PartnerSelected from over 1,100 applications to participate in flagship four-month Showcase and Accelerator program, culminating at MedTech Conference powered by AdvaMed.
• Southwest Pediatric Device ConsortiumminorStrategic or Co-development PartnerSelected for Faculty Seed Grant 2021-2022 program sponsored by Baylor College of Medicine Office of Research to pilot clinical studies with novel pediatric medical devices.
• Philadelphia Pediatric Medical Device ConsortiumminorStrategic or Co-development PartnerPediatric device consortium providing support and resources for device development.
• Advanced Medical Technology Association (AdvaMed)minorStrategic or Co-development PartnerReceived AdvaMed scholarship for Innovation Showcase at MedTech Conference, the leading event for medical technology professionals in North America.
• Future in Review (FiRe)coreStrategic or Co-development PartnerSelected as FiReStarter Company (2016), Company of the Year (2019), and Innovation Partner (2022). FiRe is described by The Economist as 'The best technology conference in the world' and has been highly accurate in predicting tech trends.
• Lurie Children's Hospital and Children's Hospital Los AngelescoreStrategic or Co-development PartnerCTIP accelerator is based at these two premier children's hospitals, providing access to clinical expertise and hospital networks for pediatric device development.

Scale indicators10 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• TytoCare: TytoCare develops a handheld telehealth device that includes an otoscope attachment for remote ear examination. Direct peer because both companies target point-of-care ear diagnostics with dedicated hardware consumables sold to primary care and pediatric providers.
• CellScope (Jawku Health): CellScope developed a smartphone-attached otoscope for parent and clinician ear examinations, positioning itself as a digital diagnostic alternative. Direct peer as both companies target ear infection diagnosis with technology-augmented alternatives to traditional otoscopy.
• Preceptis Medical: Preceptis Medical developed the Hummingbird device for in-office pediatric ear tube placement, addressing pediatric ENT procedures. Direct peer because it targets the same pediatric otology/ENT clinical specialty and channels through children's hospitals.

Broad incumbents

• Welch Allyn (Hillrom, now part of Baxter): Welch Allyn is the historic market leader in traditional pneumatic and digital otoscopes used by primary care worldwide. As the incumbent in the otoscope category, it represents the device OtoNexus must displace in clinical workflows.
• Butterfly Network: Butterfly Network produces handheld, AI-enabled ultrasound devices for point-of-care use across multiple clinical applications. Broad incumbent as it shares the handheld ultrasound technology paradigm and broad point-of-care diagnostic positioning, though not ear-specific.
• Olympus Medical: Olympus is a global leader in ENT endoscopy and surgical devices used in otolaryngology. Broad incumbent because it serves the same ENT clinical call point with a broad portfolio and possesses the scale to acquire or partner with innovative point-of-care players like OtoNexus.
• Smith+Nephew (Tusker Medical): Smith+Nephew acquired Tusker Medical, which developed in-office pediatric ear tube solutions for otitis media. Broad incumbent because it now competes in the same pediatric otitis media treatment pathway, providing a potential strategic acquirer or partner.

Emerging players

• Clarius Mobile Health: Clarius develops handheld wireless ultrasound scanners for various clinical applications. Emerging peer because it shares the miniaturized-ultrasound-for-point-of-care thesis, though its current applications are not focused on ear diagnostics.
• Sonivate Medical: Sonivate developed finger-mounted ultrasound probes for point-of-care imaging. Emerging peer because both companies pioneer novel form-factor ultrasound technology that could compete in adjacent point-of-care diagnostic niches.
• Eko Health: Eko Health makes AI-enabled digital stethoscopes and point-of-care diagnostic tools for primary care. Emerging peer as both companies target frontline clinicians with AI-powered diagnostic hardware addressing high-prevalence conditions.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/otonexus
• LinkedInlinkedin.com/company/otometrix-inc-

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Funding overview

Funding rounds15 records

Investors9 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about OtoNexus Medical Technologies Inc.