Sanoculis Receives CE Marking for MINT® Glaucoma Treatment Device

Sanoculis Achieves CE Marking for MINT® Device

Sanoculis Ltd., a pioneering name in ophthalmic medical device technology, proudly announced on April 17, 2025, that it has obtained CE Mark approval under the Medical Devices Regulation (MDR) within the European Union for its revolutionary product, MINT® (Minimally Invasive Nasal Trabeculostomy). This device is specifically designed for adult patients undergoing glaucoma angle surgery, marking a significant advancement in glaucoma treatments.

The MINT® technology employs a unique semi-automated mechanical trephination system with a minimal 0.14 mm tip diameter. This innovative technique aims to create precise openings in the trabecular meshwork, offering a stent-free approach that elevates the standards of care in glaucoma management. According to Nir Israeli, co-founder and CEO of Sanoculis, MINT® is expected to transform the field of minimally invasive glaucoma surgery (MIGS). He mentioned, "MINT® represents a substantial shift in how we approach glaucoma treatments, significantly enhancing patient outcomes while establishing a new standard of care."

Clinical data from a prospective single-arm study with a follow-up of two years demonstrate that the MINT® technology is both safe and effective for lowering intraocular pressure (IOP) while reducing the need for glaucoma medications. This promising data underlines the potential benefits of MINT® in managing glaucoma, a condition affecting an estimated 76 million people worldwide, with projections estimating that this number could rise to 112 million by 2040. Glaucoma is the second leading cause of irreversible blindness globally, underscoring the urgency for early detection and effective treatments to prevent vision loss.

Current treatment paradigms often begin with topical eye drops and can escalate to laser therapy or traditional, more invasive filtering surgery. MINT® provides an alternative path that is less invasive and designed to improve patient outcomes. Sanoculis plans to introduce a selective commercial pre-launch of the MINT® technology later this year, anticipating a positive response from the market and healthcare providers.

In summary, MINT® not only marks a significant milestone for Sanoculis, but it also represents a leap forward in the treatment options available for glaucoma patients, providing hope for better management of this chronic condition. As the company continues to push the boundaries of ophthalmic technology, it aims to deliver innovative stent-free solutions that enhance both the quality of care and the quality of life for patients.

For more information about Sanoculis and the MINT® device, visit their official website or contact Elad Shalev, Vice President of Global Marketing and Sales, at [email protected].