OtoSight Middle Ear Scope
Middle ear infections are the leading cause of hearing loss, surgery and antibiotic use, especially in children. Affecting more than 80 percent of children, they are misdiagnosed up to 50 percent of the time using the current gold standard, examination via otoscope.[i] Children can suffer from recurring ear infections for six to 12 months before they are referred to an ENT specialist, and are often prescribed increasingly potent antibiotics during this time. Often, the endpoint of the disease is insertion of tympanostomy tubes in the eardrum. More than one million tube surgeries are performed in the U.S. alone every year.
Using optical coherence tomography (OCT) high resolution depth imaging, PhotoniCare's OtoSight Middle Ear Scope helps to determine the presence or absence of fluid in the middle ear and to characterize the fluid type, even in the presence of significant ear wax. As a result, pediatric, family medicine, and urgent care clinicians can more effectively diagnosis, treat, and monitor middle ear infections. Data published in January 2020 shows that the technology used in OtoSight Middle Ear Scope is 90.6% accurate in the detection of Middle Ear Effusion.[ii] The OtoSight Exam can also be printed out or uploaded into an EMR system.
Commenting on the announcements, Cary Vance, President and CEO of PhotoniCare said, "We are very pleased to have secured the first close of our Series B financing led by Gentex Corporation, with continued participation and support from long-time PhotoniCare shareholder, Michigan Capital Network. PhotoniCare will use the proceeds to support our ongoing clinical trial, ramp production and sales of our OtoSight Middle Ear Scope, relocate our headquarters to work more closely with our new manufacturing partner, Gentex, and be nearer to our valued Michigan investor base. We are in the process of securing additional investment and expect to close out the full $9 million round in the next few months.”
Robert Vance, Vice President of New Markets at Gentex Corporation said, "Gentex is proud to invest and become a manufacturing partner of PhotoniCare to build upon the company's early commercial traction and make its OtoSight Middle Ear Scope widely available to providers actively involved in the diagnosis and treatment of middle ear infections.”
Paul D'Amato, CEO and Managing Director of Michigan Capital Network said, "We are extremely pleased to expand our investment in PhotoniCare as the company ramps up its efforts to commercialize its novel platform for front-line ear care. PhotoniCare's technology will drastically improve care for middle ear infections, which is the leading cause of hearing loss, antibiotic use, and surgeries in children.”
OtoSight is the first FDA cleared device for middle-ear visualization, offering a new revenue source for providers with unique CPT codes. OtoSight has significant commercial traction, having served more than 26,000 patients, validating product-market fit. The company has previously published three peer-reviewed manuscripts demonstrating the utility of the device, and a large randomized controlled clinical trial (RCT) is underway to help drive continued reimbursement strategy and market adoption. PhotoniCare has previously raised $17 million in private funding, welcoming partners such as Plains Ventures, OSF Healthcare Ventures, Sony Innovation Fund, Julz Co., and Dreampact Ventures. The company also previously received more than $6 million in Small Business Innovation Research (SBIR) grants from the National Institutes of Health (NIH).
[i] Pichichero, Michael E., Poole, Michael D. Assessing Diagnostic Accuracy and Tympanocentesis Skills in the Management of Otitis Media. Arch. Pediatr. Adolesc. Med. 2001. 155(10):1137-1142. doi:10.1001/archpedi.155.10.1137
[ii] Preciado D, Nolan RM, Joshi R, Krakovsky GM, Zhang A, Pudik NA, Kumar NK, Shelton RL, Boppart SA, Bauman NM. Otitis media middle ear effusion identification and characterization using an optical coherence tomography otoscope. Otolaryngol Head Neck Surg, 2020.
About PhotoniCare
Founded in 2013, PhotoniCare's mission is to improve clinical outcomes and serve unmet patient and provider needs by translating novel light-based technologies into objective medical practice, starting with the OtoSight™ Middle Ear Scope. The FDA-cleared OtoSight Middle Ear Scope was developed for healthcare providers seeking a superior solution for pediatric middle ear issues. With remarkable 90+% reader accuracy in determining the presence or absence of fluid in the middle ear, the OtoSight Middle Ear Scope eliminates subjectivity and speculation by providing patients with a non-invasive and comprehensive assessment of middle ear fluid, even in the presence of significant earwax. PhotoniCare has been recognized by numerous organizations, winning the 2021 Northwest Arkansas Tech Summit Pitch Competition, the 2018 MedTech Innovator Execution Award, and the 2018 AdvaMed Accel Virginia Shimer Rybski Memorial Award. The company was also a member of the 2016 Dreamit Ventures accelerator program and took first place at the 7th Annual Insight Product Development 2019 HealthTECH Startup Competition. PhotoniCare has received more than $6 million in support from the National Institutes of Health, most recently a Phase SBIR II award for work in artificial intelligence. In 2015, PhotoniCare was the winner of a grant from the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), an FDA-funded consortium led by Children's National Hospital. More information can be found at https://photoni.care/.
Media Contact:
David Gutierrez, Dresner Corporate Services for PhotoniCare, (312) 780-7204, dgutierrez@dresnerco.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0b6b35e1-6bf7-4842-8439-3a676ee1f361