PhotoniCare, a company dedicated to revolutionizing healthcare by providing physicians with better diagnostic tools, today announced an oversubscribed $5.2 million Series A financing led by i2E Management Company Inc., with co-investment from OSF Ventures, Sony Innovation Fund, and Dreampact Ventures. The company also announced that it has received a $2.1 million Phase II Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH). The competitive NIH SBIR program funds early-stage small businesses seeking to commercialize innovative biomedical technologies.

In January, PhotoniCare announced that the U.S. Food and Drug Administration (FDA) had granted clearance for its TOMi™ Scope for non-invasive imaging of the middle ear. The only technology capable of visualizing through the eardrum to assess middle ear fluid directly, the simple-to-use TOMi Scope helps to determine the presence or absence of fluid in the middle ear and to characterize the type of fluid.

The presence of fluid in the middle ear is a primary indicator for determining ear infection, which is the leading cause of hearing loss, surgery and antibiotic use, especially in children. More than ten million children per year experience ear infections in the U.S. alone; however, the current gold standard of otoscopy is a rudimentary tool that looks only at the surface of the eardrum, leading to misdiagnosis rates as high as 50%.

Designed to eliminate subjectivity and speculation, the TOMi Scope allows physicians, for the first time, to directly visualize fluid in the middle ear where ear infections reside, and to measure the fluid's density even in the presence of wax - providing objective data upon which to base their decisions. A recent 70-patient study with Children's National Health System in Washington, D.C., demonstrated 91% sensitivity and 90% specificity for TOMi Scope's technology for detecting fluid through the intact eardrum.

The funds will be used to expand PhotoniCare's executive team, ramp up manufacturing, execute on the company's sales and marketing plan, fuel artificial intelligence development to enable real-time decision support for the TOMi Scope, and expand reimbursement activities and customer support.

Company Appoints Jeff Hydar as Chief Commercial Officer

PhotoniCare also announced it has appointed Jeff Hydar, an award-winning strategic sales executive with over 20 years of pharmaceutical and medical device sales and leadership experience, as its new Chief Commercial Officer. Most recently, Mr. Hydar served as Vice President of Sales at Kent Imaging where he led product launches to commercialization and developed strategic partnership agreements to expand company awareness and market presence. His prior experience with Johnson & Johnson, LifeCell (Acelity), and Medline focused on launching new medical technologies and devices.

"This funding milestone, and the addition of Jeff to our team, will help us deliver on our vision to advance a new gold standard technology for ear health," said PhotoniCare co-founder and CEO Ryan Shelton. "We are grateful for strong investor support and our team's dedication. Jeff and his long track record of success launching innovative new medical technologies will be an invaluable addition as PhotoniCare transforms from a clinical- to commercial-stage company."

"PhotoniCare has made notable strides in the diagnostic space, with stand-out innovation that is raising the bar industry-wide," said newly-appointed Chief Commercial Officer Jeff Hydar. "I'm pleased to join this talented group of individuals in its mission to provide better diagnostic technologies to clinicians, starting with this simple-to-use tool for physicians, nurse practitioners, physician's assistants, nurses, and technicians."

The grant reported in this press release is supported by the National Institute on Deafness and Other Communication Disorders (NIDCD) of the NIH under Award Number 2 R44 DC17422-02. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

About PhotoniCare

Founded in 2013, PhotoniCare's mission is to revolutionize healthcare by providing physicians with better diagnostic tools, starting with the TOMi Scope the first and only otoscope to provide non-invasive imaging of the middle ear using a novel application of Optical Coherence Tomography (OCT) to directly visualize and characterize fluid in the middle ear, a necessity for the diagnosis of middle ear infections. PhotoniCare has developed a patented imaging platform that provides growth opportunities beyond otology (study of the ear). Peer-reviewed studies show that the same handheld OCT technology can be used to image other areas, such as the anterior and posterior segments of the eye, the skin, and the mouth.

PhotoniCare has been recognized by numerous organizations, winning 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 recently 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.

About i2E Management Company, Inc.

i2E Management Company, Inc. (iMCI) is a private investment and fund management company. iMCI manages $88 million across five venture funds. Since 2007, iMCI has invested more than $58 million into 56 companies representing seed to early-stage venture capital investments across many industries including life sciences and software/IT.