Europe: Sanoculis Earns CE Mark for MINT® Device in Glaucoma Treatment

Sanoculis Ltd., an innovative player in ophthalmic medical device technologies, has officially received CE Mark certification under the European Union’s Medical Device Regulation (MDR) for its revolutionary MINT® (Minimally Invasive Nasal Trabeculostomy) platform. This marks a significant milestone in advancing care for patients undergoing glaucoma angle surgery.

Unlike traditional treatments that often rely on implantable stents, MINT® is a stent-free, minimally invasive technology that harnesses a unique, semi-automated trephination mechanism. Using a precision-engineered 0.14 mm diameter tool, the device creates a controlled opening in the pigmented trabecular meshwork, enabling improved fluid outflow and reduction of intraocular pressure (IOP)—a key factor in managing glaucoma progression.

This next-generation MIGS (Minimally Invasive Glaucoma Surgery) approach not only streamlines the procedure by eliminating stents but also minimizes the risk of complications, offering an alternative that is both clinically effective and patient-friendly.

In clinical studies, MINT® demonstrated compelling outcomes, with a prospective, single-arm trial showing significant IOP reduction and decreased reliance on glaucoma medications over a two-year follow-up period. These results position MINT® as a potential game-changer in glaucoma therapy.

Nir Israeli, Co-founder and CEO of Sanoculis, emphasized the product’s impact:

“MINT® represents a substantial transformation in the field of MIGS, with significant potential to improve patient outcomes and elevate the standard of care.”

Looking ahead, Sanoculis plans a selective commercial pre-launch of MINT® in strategic EU markets later this year, paving the way for broader adoption of this novel device in ophthalmic surgical practices.