Mynosys Updates on OUS Zepto Launch
Zepto – Mynosys’ capsulotomy device used in a one-time method – was launched in India, Australia, Germany, and the US in 2017. The US clinical trial included nine surgeons (eight sites) and 100 eyes; at the one- and three-month follow-ups there were no capsule abnormalities. Overall, 70% had no change in corneal incision size after use; the mean was 0.03 mm. The trial itself was completed in 80 days; Mynosys received 510(k) clearance 89 days after submission. The Zepto is the “only device to align on visual axis of each and every patient,” CEO John Hendrick said. “It makes difficult cases easy.” Cost is considerably less than a femtosecond laser, which will be a major component of its marketing strategy. In addition, the Zepto has fewer exclusions than, and takes less time than a femtosecond laser, allowing for two to four additional cases per surgery day. As a result “the cost impact is significant,” Hendrick pointed out. Mynosys will also introduce a pediatric device in the near future.