Mynosys has developed the means to create “an ideal capsulotomy,” in its ZEPTO device, said John Hendrick, president and chief executive officer.
The ZEPTO is an “innovative, disposable capsulotomy device” that does not disrupt the natural flow of cataract procedures or patient flow, Hendrick stated. 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 said. Finally, the device requires minimal training and is very low cost.
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.
“The disposable product is ideal for capsulotomy,” Hendrick said, “with a 4 ms cutting time.”
Based on surgeon feedback, the CEO said the ZEPTO is particularly well suited for cases of white cataracts and small pupils, dense cataracts, or in cases where zonular dehiscence is a concern.
Further, the ZEPTO mandates no changes in the traditional routine of phacoemulsification surgical procedures, and creates a 2.2 mm incision.
Mynosys will begin exploring the ZEPTO’s use in pediatric indications in the future as well.
For now, however, the company has finalized its protocol for US studies, with enrollment ongoing (expected completion in November–December 2016). In Europe, two clinical sites are planned by the end of 2016.
Hendrick expects Mynosys will roll out the device in select European countries, Asia, and Latin America in January 2017, with a US introduction expected in the second quarter of 2017.
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.