Sanoculis Ltd. announced that it has received CE Mark approval under the Medical Device Regulation (MDR) in the European Union (EU) for its MINT® (Minimally Invasive Nasal Trabeculostomy) product—an innovative, stent-free technology platform for the treatment of adult patients undergoing glaucoma angle surgery.

MINT® utilizes a unique mechanical, semi-automated trephination technology with a cutting-edge diameter of 0.14 mm to create precise openings in the pigmented trabecular meshwork. This stent-free approach is designed to elevate the standard of care by offering a less invasive, more effective treatment option for glaucoma patients.

"MINT® represents a substantial transformation in the field of Minimally Invasive Glaucoma Surgery (MIGS), with significant potential to improve patient outcomes and elevate the standard of care," said Nir Israeli, Co-founder and CEO of Sanoculis. "Clinical data from our prospective, single-arm study with a two-year follow-up indicate that MINT® is both safe and effective in lowering intraocular pressure (IOP), while also reducing the need for glaucoma medications."

Sanoculis plans a selective commercial pre-launch rollout of the MINT® technology later this year.