Ear infections are a common occurrence in kids, causing pain, fever and, in worst cases, hearing loss. Yet up to half of all cases are misdiagnosed, due to doctors’ inability to look deep into the middle ear where infections reside. Now, the U.S. FDA has cleared the Tomi Scope, a first-in-class technology from Photonicare Inc., of Champaign, Ill., that allows doctors to not only detect the presence or absence of fluid in the middle ear but characterize the type of fluid they see.
The agency cleared the Tomi Scope for noninvasive imaging of the middle ear under a new product code, QJG. “I can’t directly speak for the FDA, but I think this underscores how differentiated our solution is,” Ryan Shelton, Photonicare’s co-founder and CEO, told BioWorld MedTech. “It had never been done before, and we see it as a meaningful step forward” in assessing middle ear infections.
For nearly two centuries, physicians have relied on the otoscope to screen for illness during regular exams and investigate earaches and other ear symptoms. But these devices can only view the ear canal and eardrum, not the middle ear, which is crucial in detecting middle ear infections. Of the more than 80% of children who get these infections, up to 50% are misdiagnosed using otoscopes, resulting in recurrent infections, use of increasingly potent antibiotics and surgery. Each year, more than 1 million kids in the U.S. have ear tubes placed in their ears to help drain fluid from the middle ear.
By contrast, the Tomi Scope uses optical coherence technology (OCT) high-resolution depth imaging, a noninvasive imaging technology that relies on near-infrared light waves to evoke 3D views within living tissue, much as ultrasound uses sound waves.
The system is comprised of a hand-held piece, which is tethered to a portable or wall-mountable console for reviewing and sharing images in real time with patients and their parents. It provides a real-time view of both the surface image that a traditional otoscope captures, but digitally and with very high quality, Shelton explained, as well as more in-depth imaging of what lies behind the eardrum.
To support its 510(k) application, Photonicare submitted both patient data and bench validation, Shelton said. “We showed data that … we were able to detect fluid in the middle ear and measure the density even in the presence of up to 90% ear wax occlusion in the ear canal,” he said. “That’s a really important piece, because if you ask any doctor, any pediatrician, ENT, ear wax is a huge problem with diagnosis” of middle ear infections.” The studies are currently under review for publication.
Diego Preciado, a pediatric otolaryngologist at Children’s National Hospital in Washington, and a lead investigator for the device, agreed. “Tomi Scope’s advanced light-based technology could dramatically alter the way children with ear problems are evaluated, enhancing our ability to inform optimal treatments.”
Series A round underway
Photonicare plans to release the Tomi Scope immediately via an early access program, with a full nationwide launch later this year. While the big focus initially is on pediatricians and urgent care clinics, the company sees a broad range of potential customers who routinely diagnose ear infections. These include family and general practitioners, ENTs and retail care, such as Walgreens and CVS.
“Photonicare is currently in the midst of a series A financing, with hopes of raising between $10 million to $15 million – enough to get us through the launch and the milestones that we need over the next couple of years,” Shelton said.
For 2020, the company is looking to build out its sales team and establish distribution partnerships that will help it reach its different customer demographics. Photonicare signed an exclusive distribution agreement with Adachi Co. Ltd., of Osaka, Japan, to commercialize its Tomi Scope throughout that country. The device is currently under review in Japan and the European Union, and Shelton said Photonicare is looking at additional markets in the Middle East, Australia and Canada.
With the commercial launch of the Tomi Scope now underway, Photonicare is looking to expand its product pipeline. Shelton said the company has evidence showing that the underlying technology it developed can be used on a number of other tissue sites, including the eye, teeth, oral tissue and skin. “We see this as a platform opportunity, and we’re really excited about where we can go from there,” he said. “Part of what we’ll be doing in 2020 is narrowing down and investing in the next indication on our platform.”