OtoNexus has been selected for the U.S. Food and Drug Administration (FDA) Safer Technologies Program (STeP), which is intended to facilitate development and review for certain devices that may offer meaningful safety advantages over existing alternatives. Participation in STeP supports earlier and more structured engagement with FDA to align on evidence expectations, development priorities, and submission readiness. This can improve execution predictability by helping teams address key regulatory questions earlier in the development cycle. STeP selection is a program designation and does not represent FDA clearance or approval.

OtoNexus’s commercial model combines capital device placement with recurring consumables revenue. The ultrasound otoscope is sold (or placed) as durable equipment, creating an installed base in clinics. 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.

The market opportunity for the OtoNexus ultrasound otoscope is huge, with a multi-billion-dollar yearly revenue potential in the U.S. alone and even greater opportunities globally. This is a blue ocean market space with immense growth potential, as no other product on the market can identify bacterial middle ear infections with the precision and speed that our device offers. The ability to accurately detect bacterial infections provides the critical information physicians need to determine the appropriateness of antibiotic therapy—a capability that positions OtoNexus as a leader in reducing unnecessary antibiotic prescriptions.

Beyond its current application in detecting middle ear infections, the underlying ultrasound technology platform has additional potential for both medical and industrial uses, all of which are protected by patents. This opens up further avenues for growth and revenue diversification. OtoNexus has received over 69 patents for this unique technology, creating a strong patent moat that strengthens the company’s competitive edge, protects its technology and revenue streams, and enhances market leadership.tem description