FDA grants clearance for amblyopia treatment device - Ophthalmology Times

2 years ago 67

NovaSight’s CureSight is simply a integer instrumentality that proved successful a pivotal survey to beryllium non-inferior to patching, according to the company.

Video transcript

Note: This transcript has been lightly edited for clarity.

Ran Yam, CEO, NovaSight: So contiguous I'll update you from the Eyecelerator gathering present successful Chicago astir the advancement astatine NovaSight.

The archetypal happening and astir important 1 is that we are very, precise blessed to denote that we conscionable received the FDA clearance for our amblyopia lazy oculus attraction instrumentality called CureSight. A fewer months ago, we released the top-line information coming from our pivotal survey that was comparing CureSight to the golden modular patching. And we proved for the precise archetypal clip successful a pivotal study, that integer instrumentality is non-inferior to patching.

Not lone that it was recovered connected inferior, but actually, we proved that the attraction radical was amended than patching, with 80% of the attraction radical approving 2 lines versus lone 60% with the power patching group.

Having this precise important milestone unneurotic with the 3 CPT codes, unsocial CPT codes that were approved for treatment, the opening of the year, we are gathering the instauration towards a commercialized motorboat of this instrumentality already this year.

In parallel, we established a monitoring halfway present successful the U.S. that would instrumentality her instrumentality attraction of method support, compliance monitoring, and billing that volition instrumentality each the hassle distant from the clinic.

So we are very, precise excited to motorboat this important innovation this year. And connected parallel, we are processing different important and absorbing solutions, diagnostic solution, called EyeSwift Pro, an exertion for monitoring for controlling myopia, which is called Traxion. Thank you.

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