Mynosys Eye Commercial Launch of Zepto
Zepto represents an “innovative, disposable capsulotomy device,” said president and CEO John Hendrick. It does not disrupt the natural flow of cataract procedures or patient flow. Its proprietary cutting edge doesn’t burn tissue (no cautery, thermal burning), but instead cleaves the tissue, providing an “unusual edge to the capsulotomy,” he explained. Finally, the device requires minimal training and is very low cost.
Zepto employs a host of unique features to enhance outcomes in either anterior or posterior capsulotomy. It creates suction on the capsule such that there is no movement during the 4-msec cutting time that provides a uniform capsulotomy. There is also incredible zonular stability (to address weak zonules); Zepto can be inserted under small pupils (as small as 4 mm) through a 2.8-mm incision, and can be used safely and effectively with corneal opacities. Finally, the device can be centered over the visual axis.
Zepto comprises a disposable handpiece, a capsulotomy tip, and a power supply. The tip is silicone, and there’s a nitinol ring that allows for folding.
During the milliseconds-long procedure, studies show no significant temperature changes in the eye.
Edge strength is “much stronger than either a femtosecond laser or a continuous curved capsulorhexis,” Hendrick said. An evaluation conducted in El Salvador (n = 20) included several challenging cases (brown cataracts, pterygium, small pupils) and there were no reported problems out to 30 days.
Zepto was granted the CE mark in November 2015, and Mynosys expects to commercially launch in September 2016. A single-arm protocol with four weeks of follow-up was submitted to the FDA for 510(k) approval, with a US introduction expected before year-end.
Mr. Hendrick has over three decades of executive experience, building both early stage medical device companies as well as large divisions in Medical device Corporations.