#Israel #Tel Aviv #glaucoma #MINT® #Sanoculis

Sanoculis Gains CE Mark Approval for MINT® Device

Sanoculis Ltd., a prominent player in the ophthalmic medical device industry, has recently received CE Mark approval for its groundbreaking product, MINT® (Minimally Invasive Nasal Trabeculostomy). This innovative device is designed specifically for treating adult patients undergoing angle surgeries due to glaucoma. The approval signifies compliance with the Medical Device Regulation (MDR) in the European Union, allowing for a broader market entry and enhancing patient access to advanced glaucoma treatment options.

About MINT® Technology

The MINT® device incorporates a unique semi-automated mechanical trephination technology with a precise tip diameter of 0.14 mm. This sophisticated mechanism enables the creation of accurate openings in the trabecular meshwork, facilitating enhanced intraocular fluid drainage. Unlike traditional methods that may require stents, MINT® is designed to minimize invasiveness, potentially elevating the standard of care and delivering a more effective solution for patients suffering from glaucoma.

Nir Israeli, co-founder and CEO of Sanoculis, emphasized the transformative potential of MINT® in the field of minimally invasive glaucoma surgery (MIGS). He mentioned, "MINT® represents a significant shift in the treatment paradigm with promising results for lowering intraocular pressure (IOP) and reducing the reliance on glaucoma medications."

Clinical Efficacy and Safety

Clinical data from a prospective single-arm study with two years of follow-up revealed that MINT® is both safe and effective in lowering IOP among users. Such results highlight the potential benefits of this technology and its capacity to improve the quality of life for individuals affected by glaucoma. By providing a more efficient treatment avenue, MINT® aims to tackle the increasing prevalence of this condition, which currently affects approximately 76 million individuals worldwide and is projected to reach 112 million by 2040.

Understanding Glaucoma

Glaucoma is the second leading cause of irreversible blindness globally. The condition is often chronic, requiring regular monitoring and intervention to prevent vision loss. Early detection and treatment are essential, as the disease typically results in progressive damage to the optic nerve, impairing the visual field. Current treatment strategies usually begin with topical medications, potentially advancing to laser therapies or traditional glaucoma surgery if necessary.

Given the chronic nature of glaucoma, timely intervention can significantly mitigate the risks of severe visual impairment. The field has been evolving towards less invasive solutions, highlighting the importance of innovations like MINT® that offer patients options with reduced procedural risks.

Upcoming Launch and Future Prospects

Sanoculis plans to initiate a selective commercial pre-launch of the MINT® technology later this year. This strategic move aims to ensure that practitioners and patients are equipped with the latest advancements in glaucoma management, thereby enhancing treatment outcomes.

Sanoculis Ltd. specializes in pioneering ophthalmic medical device technologies, offering stent-free and minimally invasive solutions designed to optimize surgical procedures like sclerostomy and trabeculotomy during glaucoma surgeries. The company's mission is to create cutting-edge platforms that significantly improve patient care quality and outcomes for individuals suffering from glaucoma.

For further inquiries or information about the MINT® device, interested parties can reach out to Elad Shalev, Global Marketing and Sales VP, at [email protected], or via phone at +972509827282.

Conclusion

The CE Mark approval for Sanoculis' MINT® product marks a milestone in glaucoma treatment technology. It highlights the growing trend towards minimally invasive surgical options and sets a new standard of care that emphasizes patient safety and efficacy in managing this prevalent eye condition.