Photonicare

Market position

PhotoniCare describes OtoSight as the first FDA-cleared device for middle-ear visualization and a first-in-class technology for imaging the middle ear, positioned against the conventional otoscope, which sources describe as largely unchanged for 150 years and as providing only a surface view of the eardrum. The market context cited includes middle ear infections affecting more than 80% of children, being a leading cause of hearing loss, antibiotic use and surgery, and more than one million tympanostomy tube surgeries performed annually in the U.S.

Unlike the standard otoscope, which shows only the surface of the eardrum, OtoSight images through the tympanic membrane to visualize middle ear contents directly, characterizing fluid type and density even when significant earwax is present, and the company states results are minimally affected by user or patient variability. It is described as the first FDA-cleared middle-ear visualization device, with unique CPT codes, and it packages OCT capability, normally delivered by large desktop systems, into a handheld form factor.

Technology

OtoSight uses optical coherence tomography, a near-infrared, high-resolution depth-imaging modality that is the established standard for retinal examination in ophthalmology, miniaturized from a desktop system into a handheld probe. It presents two views: true-color video otoscopy of the canal and eardrum, and a depth-resolved middle ear scan through the intact tympanic membrane that detects and characterizes effusion and measures fluid density even with cerumen present. Supporting capabilities include image analysis and turbidity quantification, clinical image capture and recording, and AI-driven decision support under development; NIH SBIR funding of $2.2 million (Phase 2) was directed at artificial intelligence and machine learning programs. Published data indicate 90.6% accuracy in detecting middle ear effusion, and a 70-patient study with Children's National Health System in Washington, D.C. showed 91% sensitivity and 90% specificity for detecting fluid through the intact eardrum.

Go-to-market

The company launched commercially through a regional "Trailblazer" early-adopter program giving selected clinics first exclusive use of the technology, initially targeting specific U.S. regions including North Carolina, backed by clinical training, co-marketing and reimbursement/coding support. It has published peer-reviewed evidence and run clinical trials to support reimbursement strategy and adoption, and appointed a Chief Commercial Officer (Jeff Hydar) in 2020 to build sales and marketing. Internationally it uses a distributor partnership in Japan and has piloted with Aboriginal populations in Australia.

Frontline care providers treating middle ear conditions, primarily pediatric, family medicine and urgent care clinicians, with stated future expansion to emergency departments and other providers. Users include physicians, nurse practitioners, physician assistants, nurses and technicians. Patients are predominantly children, who account for the bulk of middle ear infections, though the condition also affects adults.

Geography

Founded and originally based in Champaign, Illinois, with a tenancy at the University of Illinois Research Park. The company expanded to North Carolina in 2021, using the North Carolina Biotechnology Center Landing Pad in Research Triangle Park, and is listed at 2800 Meridian Parkway, Suite 175, Durham, NC 27713. In December 2024 it announced relocation of its headquarters from Champaign to Grand Rapids, Michigan, near its manufacturing partner Gentex and its Michigan investor base. Commercial activity outside the U.S. includes a distributor partnership in Japan and a pilot program in Australia.

History

The company was founded in 2013 and was a tenant of EnterpriseWorks at the University of Illinois Research Park from 2014 to 2019, graduating in 2019 and remaining in Champaign, Illinois with 13 staff members. It won the SPIE Startup Challenge top prize at Photonics West in February 2018 (a combined first prize of $15,000) and also received the MedTech Innovator Execution Award and the AdvaMed Accel Virginia Shimer Rybski Memorial Award in 2018. The FDA granted 510(k) clearance for the middle ear imaging device (then called the TOMi Scope) in January 2020, and the technology was later rebranded as the OtoSight Middle Ear Scope. A $5.2 million Series A and a $2.1 million NIH Phase II SBIR grant were announced in September 2020. In 2021 the company expanded to North Carolina, taking space at the North Carolina Biotechnology Center's Landing Pad in Research Triangle Park, and it announced ISO 13485:2016 certification in December 2021. In December 2024 PhotoniCare announced a $4.6 million first close of a Series B led by Gentex Corporation, a manufacturing partnership with Gentex, and relocation of its headquarters from Champaign to Grand Rapids, Michigan. In May 2025 it reported results from a large randomized controlled trial of OtoSight.

Risks & controversies

As of the December 2024 announcement the Series B was only partially funded, with $4.6 million closed against an expected $9 million round and additional investment still being sought. The company remains dependent on reimbursement adoption for novel CPT-coded procedures and on clinical trial outcomes to drive market uptake, and has relied substantially on NIH SBIR grant funding. AI-driven decision support is described as still under development.