Sanoculis Secures CE Mark for Innovative Glaucoma Treatment Device

Sanoculis Ltd., a pioneering company in ophthalmic medical technologies, has recently celebrated a significant milestone in the medical field by receiving the CE Mark approval for its groundbreaking product, MINT® (Minimally Invasive Nasal Trabeculostomy). This recognition, granted under the Medical Device Regulation (MDR) of the European Union, allows Sanoculis to market this innovative device designed to treat adult patients undergoing glaucoma angle surgery.

What is MINT®?

MINT® represents a new frontier in the management of glaucoma, leveraging a state-of-the-art mechanical and semi-automated trephination technology that operates at an astonishing diameter of just 0.14 mm. Its advanced design creates precise openings in the pigmented trabecular meshwork, leading to improved intraocular pressure management. The stent-free design of MINT® sets it apart from traditional glaucoma treatments, offering a less invasive, more efficient approach to care.

Nir Israeli, the Co-founder and CEO of Sanoculis, describes MINT® as a transformative force within the realm of Minimally Invasive Glaucoma Surgery (MIGS). He explains that the clinical data emerging from their prospective, single-arm study—which includes a two-year follow-up—highlight MINT®'s safety and efficacy in significantly lowering intraocular pressure (IOP). This reduction is paramount, as it minimizes the dependency on glaucoma medications that patients often face.

The Importance of Addressing Glaucoma

Glaucoma is recognized as one of the foremost global health challenges, affecting approximately 76 million individuals worldwide, a figure projected to escalate to 112 million by 2040. The condition is notoriously known as the second leading cause of irreversible blindness. Many types of glaucoma are chronic, and if not detected or treated in a timely fashion, they can result in irreversible vision loss. Early intervention is vital, as it can stave off the deterioration of the optic nerve, which ultimately leads to progressive visual field loss.

The current approach in treating glaucoma begins with topical eye drops but may progress to other methods like laser therapy or MIGS before resorting to more invasive surgical interventions. MINT® aims to revolutionize this by streamlining the treatment process and enhancing effectiveness.

Sanoculis' Vision

Sanoculis, through its innovative spirit and forward-thinking approach, aims to redefine the treatment landscape for patients worldwide. The company is committed to developing advanced, proprietary, stentless technologies specifically designed for glaucoma surgeries, striving to improve the standard of care and ultimately enhance patient outcomes. The upcoming selective commercial pre-launch of their MINT® technology later this year marks the beginning of a new chapter in glaucoma treatment.

In conclusion, the CE Mark approval for the MINT® device underscores Sanoculis' dedication to advancing ocular health technologies. As the fight against glaucoma continues, innovations like MINT® promise to offer new hope for millions, improving lives one patient at a time.