PhotoniCare develops the OtoSight Middle Ear Scope, an FDA-cleared medical device that uses optical coherence tomography (OCT) high-resolution depth imaging to detect and characterize middle-ear fluid even in the presence of ear wax. The device is intended for frontline clinicians in pediatrics, family medicine, and urgent care to improve diagnosis, treatment, and monitoring of middle ear infections. OtoSight has unique CPT codes and has served more than 26,000 patients, indicating early commercial traction and a potential new revenue source for providers. The company has published three peer-reviewed manuscripts and has a large randomized controlled clinical trial (RCT) underway to support reimbursement strategy and broader adoption. PhotoniCare recently formed a manufacturing partnership with Gentex Corporation and relocated its headquarters from Champaign, Illinois to Grand Rapids, Michigan to work more closely with that partner. The company will use new funding to support the ongoing clinical trial, ramp production and sales of OtoSight, and complete its planned $9 million Series B close. PhotoniCare's core product, the TOMi Scope, is the first and only otoscope using Optical Coherence Tomography (OCT) to visualize and characterize fluid in the middle ear through the intact eardrum. The device measures fluid density even in the presence of wax, providing objective data to inform diagnosis of middle-ear infections. The TOMi Scope received FDA clearance in January. A 70-patient study with Children’s National demonstrated 91% sensitivity and 90% specificity for detecting middle-ear fluid. PhotoniCare plans to expand its executive team, ramp manufacturing, execute its sales and marketing plan, fuel AI development for real-time decision support, and expand reimbursement activities and customer support. Financially, the company announced new funding including a $5.2M Series A and a $2.1M Phase II SBIR grant to support commercial expansion and AI work.

Total raised

$12M

Funding rounds

3

Latest round

Series B

Latest activity

Dec 2024