OtoNexus
Seattle, US · Founded 2010 · 24 employees on LinkedIn · 10 known investors
OtoNexus Medical Technologies is developing an ultrasound-based otoscope (Novoscope) that uses a miniaturized sensor in a single-use ear speculum tip to give clinicians objective, point-of-care data on middle-ear fluid and infection type. The device targets pediatric otitis media diagnosis to support antibiotic stewardship and reduce misdiagnosis for physicians, hospitals, and payers.
Also known as OtoNexus Medical Technologies · OtoNexus Medical Technologies Inc.
Founders & leadership
Investors · 10
Also in the syndicate · 1
Company profile
researched Aug 2026OtoNexus Medical Technologies Inc. is a medical device company based just outside Seattle, Washington, developing an ultrasound-based otoscope (the Novoscope) for assessment of middle ear infections (otitis media). The device applies through-air ultrasound from a sensor miniaturized inside an ear speculum tip, so no gel coupling is required, and a proprietary algorithm analyzes the returned data to identify the presence and type of middle ear effusion within seconds using a one-button workflow. The company states the system is designed to detect middle ear effusion and differentiate viral from bacterial infection, information that it says has previously required an invasive procedure.
The stated clinical purpose is to reduce diagnostic uncertainty in frontline settings and support antibiotic stewardship, aligning with American Academy of Pediatrics guidance on prudent antibiotic prescribing. The company cites otitis media as the leading reason for antibiotic prescriptions and for surgery in children, notes that current tools achieve roughly 50% accuracy in distinguishing viral from bacterial infection, and states a goal of halving antibiotic use for middle ear infections. Product features described include a universal-sized speculum covering newborn through 18 years of age, single-use disposable tips, and direct transfer of exam results, images and video to electronic medical records.
The company reports over 110 patents covering the technology and says the underlying ultrasound platform has potential additional medical and industrial applications. It was selected for the FDA Safer Technologies Program (STeP) in December 2023, a designation that does not constitute clearance or approval, and was accepted into the FDA-funded Consortium for Technology & Innovation in Pediatrics (CTIP) accelerator in the same month.
Founding story
The concept originated with Dr. George Gates, an ENT surgeon of more than four decades who was dissatisfied with the accuracy and reliability of available tools for detecting and diagnosing middle ear infections and considered whether ultrasound could address the gap. He brought the problem to Dr. Mark Moehring, an ultrasound innovator who had previously developed transcranial Doppler ultrasound, whose challenge was to make ultrasound work without traditional gel coupling while imaging the middle ear. Caitlin Cameron is identified as Chair of the Board, Chief Executive Officer and co-founder, and leads the commercialization team.
Business model
The commercial model combines capital device placement with recurring consumables revenue: the ultrasound otoscope is sold or placed as durable equipment to build an installed base in clinics, while each exam consumes a single-use disposable tip, tying repeat purchases to utilization. The company describes this as razor/razorblade economics.
Device sales or placements plus recurring revenue from one-use-per-patient disposable speculum tips that scale with exam volume across the installed base.
Traction
The company reports completed clinical studies, with surgical correlation studies and microbiota analyses cited as validating accuracy, and early clinical work at leading institutions. Regulatory and program milestones include FDA STeP selection in December 2023 and acceptance into the CTIP pediatric device accelerator in December 2023. Keiretsu Capital and Keiretsu Forum members had invested a total of $13 million since inception as of July 2020, across four consecutive rounds. Non-dilutive support has come from the National Institutes of Health, the National Science Foundation, the State of Washington Life Sciences Discovery Fund and pediatric device consortia. The product had not received FDA clearance or approval based on available material.
Latest developments
OtoNexus was named a Most Valued Company and Second Runner-Up at the Keiretsu Capital Summer Investor Capital Expo 2026, an award determined by investor voting. In September 2025 it ranked #4 in the Micro Companies category of the Puget Sound Business Journal's Washington's Best Workplaces for 2025. In November 2024 MedTech Outlook named it a Top MedTech Provider 2024, and in August 2024 it was named Most Valued Company at the Keiretsu Forum Investor Capital Expo 2024, while CEO Caitlin Cameron was recognized in Keiretsu Forum's Women of Innovation series.
▸Full profile — market position, technology, go-to-market, geography, history, risks & controversies
Market position
The company positions the product as the first ultrasound-based handheld device able to evaluate the disease states of middle ear infection and characterizes the segment as a blue ocean space, asserting that no competing product identifies bacterial middle ear infections with comparable precision and speed. It cites over $5 billion in annual U.S. healthcare expenditure on treatment and management of otitis media and describes multi-billion-dollar annual U.S. revenue potential.
Miniaturized through-air ultrasound in a disposable speculum tip that requires no gel, automated measurement with results in about two seconds, ability to characterize effusion type rather than rely on subjective visual inspection, a universal speculum size spanning newborn to 18 years, EMR integration, and a patent portfolio of more than 110 patents.
Technology
Proprietary application of through-air ultrasound, with the sensor miniaturized to fit within the tip of an ear speculum, eliminating the need for gel coupling. A proprietary algorithm, described by the company as AI-driven, analyzes the ultrasound data to identify the presence and type of middle-ear fluid; measurement is automated and initiates when conditions are optimal, returning results in about two seconds. The handheld device resembles a traditional otoscope and fits in a lab coat pocket, and results integrate directly with electronic medical records. The company reports more than 110 patents on the technology.
Go-to-market
The company plans clinic-level adoption through placement or sale of the device with minimal training, integration into existing clinical workflows and EMRs, and pull-through of disposable tips. It has pursued visibility and support through angel investor networks (Keiretsu Forum and Keiretsu Capital), pediatric device consortia and accelerators including CTIP, the Southwest Pediatric Device Consortium, the Philadelphia Pediatric Medical Device Consortium and MedTech Innovator, and has an investor information page and direct contact channels for investor inquiries. Commercialization leadership includes a Chief Product and Marketing Officer and a commercialization consultant with backgrounds at FujiFilm SonoSite, Philips and GE Healthcare.
Frontline clinicians including physicians, nurse practitioners and physician assistants, particularly in pediatric care; the company also identifies hospitals and medical societies, insurance companies, and parents and patients as stakeholder groups that would benefit.
Geography
Headquartered near Seattle, Washington, United States, with a stated primary market focus on the U.S. and described longer-term global opportunity.
History
The company grew out of a collaboration between ENT surgeon Dr. George Gates and ultrasound innovator Dr. Mark Moehring on applying ultrasound to middle ear diagnosis. By July 2020 it had received four consecutive investments from Keiretsu Capital, totaling $13 million from Keiretsu Capital and Keiretsu Forum members since inception, with the 2020 round intended to finalize product development and testing for market introduction. In December 2023 it was selected for the FDA Safer Technologies Program and accepted into the CTIP pediatric medical device accelerator. Subsequent years brought industry awards and workplace recognition while development continued toward commercialization.
Risks & controversies
The device remains in development and has not received FDA clearance or approval; the company notes that STeP selection is a program designation only. Market size, accuracy and clinical benefit claims on the company website are self-reported.
Compiled by commissioned research from 8 cited public sources — announcements, filings, and press listed under research sources below.
Key figures
latest reportedCompany-reported or press-reported figures, each dated to when it was claimed — not independently audited.
Non-dilutive funding · 4 SBIR/STTR awards
Federal grants — no equity taken| Agency | Phase | Year | Amount |
|---|---|---|---|
| National Science Foundation | Phase II | 2019 | $718.1K |
| National Institutes of Health (NIH)National Institutes of Health | Phase II | 2017 | $998.6K |
| National Science Foundation | Phase I | 2017 | $225K |
| National Institutes of Health (NIH)National Institutes of Health | Phase I | 2016 | $147.9K |
Source: SBIR.gov award data (U.S. Small Business Administration). SBIR/STTR awards are competitive federal R&D grants and contracts — non-dilutive capital alongside any venture rounds above.
Timeline · 8
launches, deals, and filingsOtoNexus was named to Puget Sound Business Journal's Washington's Best Workplaces for 2025, ranking #4 in the Micro Companies category; the program recognizes 100 employers statewide based on confidential employee surveys.
OtoNexus was named Most Valued Company at the Keiretsu Forum Investor Capital Expo held August 15, 2024 at the Hyatt Regency Bellevue, an event that drew over 650 investors, family offices and industry leaders.
OtoNexus was accepted into The Consortium for Technology & Innovation in Pediatrics (CTIP), an FDA Pediatric Device Consortia grant-funded accelerator based at Lurie Children's Hospital and Children's Hospital Los Angeles, spanning a network of 25 organizations across eight states.
OtoNexus was selected for the U.S. FDA Safer Technologies Program for its Novoscope ultrasound otoscope. STeP provides expedited development and review interactions; the designation is not a clearance or approval.
Keiretsu Capital invested in OtoNexus for the fourth time, from Keiretsu Capital Co-investment Funds I, II, III and IV. Keiretsu Capital and Keiretsu Forum members had provided a total of $13 million since the company's inception. The round was intended to enable OtoNexus to finalize product development and testing for market introduction.
Dated company events from announcements, filings, and press; legal rows summarize public dockets and regulator releases.
▸Research sources · 8
primary sources listed
- OtoNexusotonexus.com · web
8 public sources were cited for this profile; the first-party ones are listed here.
Frequently asked questions
- What does OtoNexus do?
- OtoNexus is developing an ultrasound otoscope that objectively assesses middle ear infections at the point of care.
- Who are OtoNexus's investors?
- OtoNexus's investors include Golden Seeds, Dellin Investments, Farvatn Venture, Keiretsu Forum, Mindshift Capital, Portfolia, SeaChange, SPRINGROCK VENTURES and 1 more.
- Where is OtoNexus headquartered?
- OtoNexus is headquartered in Seattle, US.