Sanoculis Celebrates CE Mark Approval for MINT® Technology
Sanoculis Ltd., a pioneer in ophthalmic medical device technologies, has notably received CE Mark approval for its innovative MINT® (Minimally Invasive Nasal Trabeculostomy) product. This approval signifies a milestone in the development of cutting-edge solutions aimed at treating glaucoma, specifically targeting adult patients requiring angle surgery.
Innovative Features of MINT® Technology
The MINT® approach employs a unique mechanical, semi-automated trephination technology that boasts a precise diameter of 0.14 mm. This design facilitates the creation of accurate openings in the trabecular meshwork, offering a stent-free solution that could redefine treatment protocols for glaucoma patients. The stent-free technology aims to enhance the standard of care significantly, providing a less invasive, yet effective option for managing this serious eye condition.
Transformative Impact on Glaucoma Surgery
Nir Israeli, Co-founder and CEO of Sanoculis, emphasizes that MINT® represents a transformative leap in Minimally Invasive Glaucoma Surgery (MIGS). "Clinical studies show that MINT® is not only safe but also effective at lowering intraocular pressure (IOP). Additionally, it diminishes dependency on glaucoma medications, potentially revolutionizing patient treatment plans," stated Israeli.
This clinical data originates from a comprehensive, single-arm study with a two-year follow-up, reinforcing the technology's efficacy. Given the rising rates of glaucoma worldwide, innovations like MINT® are essential for improving patient outcomes.
Plans for Commercial Launch
Sanoculis has outlined plans for a selective commercial pre-launch of the MINT® technology later this year. By focusing on targeted markets first, the company aims to gauge the product's reception and effectiveness before wider distribution.
The Global Fight Against Glaucoma
Glaucoma currently affects around 76 million individuals globally, with projections indicating that this figure could escalate to 112 million by 2040. Recognized as the second leading cause of irreversible blindness, glaucoma management necessitates prompt and effective intervention. Without early detection and treatment, it can lead to permanent visual impairment caused by optic nerve deterioration and progressive loss of the visual field.
Currently, lowering IOP remains the only established treatment approach for glaucoma. Patients typically start with topical eye drops, progressing to laser therapy or MIGS if necessary, before considering more invasive surgery.
Who is Sanoculis?
Sanoculis Ltd. is dedicated to advancing ophthalmic medical device technologies. Their team has created proprietary, stent-free, minimally invasive solutions that improve procedures such as sclerostomy and trabeculostomy during glaucoma surgeries. The company strives to elevate the standard of care and enhance treatment outcomes for patients dealing with glaucoma.
Contact Information
For further inquiries, please contact:
Elad Shalev
VP of Global Marketing and Sales
+972509827282
Frequently Asked Questions
What is the MINT® product?
MINT® is a stent-free technology platform developed by Sanoculis for the treatment of glaucoma through minimally invasive angle surgery.
Why is the CE Mark important?
The CE Mark signifies that MINT® meets European Union standards for safety and effectiveness, allowing Sanoculis to market the product in EU member states.
What makes MINT® unique?
MINT® utilizes a 0.14 mm mechanical trephination technology which allows for the creation of precise openings in the trabecular meshwork without the use of stents.
How does Sanoculis plan to launch MINT®?
Sanoculis plans a selective pre-launch rollout of MINT® technology later this year to assess market reception and effectiveness.
What is the significance of lowering IOP?
Lowering intraocular pressure (IOP) is critical for managing glaucoma, as it helps prevent the deterioration of the optic nerve and reduces the risk of vision loss.
