AIRPORT CITY, Israel—NovaSight, a pediatric-focused eyecare company, announced that it has reached several key milestones that signal progress toward the launch of its CureSight digital treatment device for amblyopia and the establishment of a reimbursement structure for the physicians and patients who use it. NovaSight took an important step toward establishing health insurance reimbursement for CureSight when the American Medical Association (AMA) assigned three Current Procedural Terminology (CPT), or billing, codes that are unique to the company’s technology. The assignment marked the first time the AMA awarded codes to an eye-tracking amblyopia treatment. The codes will allow physicians the opportunity to potentially be reimbursed for their services related to the use of CureSight in children with amblyopia, and for patients’ health insurance plans to reimburse them for the treatment. Amblyopia, commonly known as lazy eye, affects about 3 percent of the population and, if not treated, can lead to acute and lasting visual impairment.
Additionally, NovaSight is sponsoring a randomized clinical trial that will generate data about CureSight for inclusion in an early 2022 510(k) clearance submission to the FDA, which could lead to the agency’s approval of the technology, according to NovaSight. Since June 2020, NovaSight has enrolled 67 of a targeted population of 90 children with amblyopia in the ongoing Israeli randomized, controlled trial that—for the first time as part of a 510(k) pivotal study—is comparing vision outcomes with CureSight versus the current standard-of-care treatment using an eye patch. NovaSight is on track to initiate a supplementary trial this month for patients ages 4 to 9 in the United States.
With an implementation date of January 1, 2022, the CPT codes assigned to CureSight are 0X57T, associated with the equipment needed for remote treatment of amblyopia using an eye-tracking device; 0X58T, associated with surveillance-center technical support of patient activity on the device; and 0X59T, associated with physician interpretation and reporting of the data collected through the technology.
NovaSight is pursuing the development of CureSight in addition to its commercially available EyeSwift vision assessment system, which is distributed globally by EssilorLuxottica
. After securing $8 million in series A financing in 2020, NovaSight is seeking additional partners this year for a series B funding effort anticipated to total $15 million.
“As the only company in the world focusing strictly on pediatric ophthalmology as a whole, we have a unique dedication to building a complete ecosystem for these patients that incorporates both diagnostics and treatment,” said NovaSight CEO and co-founder Ran Yam. “The future vision and eye health of these children depends on the quality and effectiveness of the care they receive in their early years. CureSight offers the opportunity to change the standard of care in patients with amblyopia, and as such, we’re thrilled to have surpassed these key milestones in our development of CureSight, the digital technology that will play a big part in helping us fulfill our commitment to this community.”