PR Newswire
Sanoculis Ltd., a company specializing in ophthalmic medical device technologies, today announced that it has received CE Mark approval under the Medical Device Regulation (MDR) in the European Union (EU) for its MINT® (Minimally Invasive Nasal Trabeculostomy) product—an innovative, stent-free technology platform for the treatment of adult patients undergoing glaucoma angle surgery.
MINT® utilizes a unique mechanical, semi-automated trephination technology with a cutting-edge diameter of 0.14 mm to create precise openings in the pigmented trabecular meshwork. This stent-free approach is designed to elevate the standard of care by offering a less invasive, more effective treatment option for glaucoma patients.
"MINT® represents a substantial transformation in the field of Minimally Invasive Glaucoma Surgery (MIGS), with significant potential to improve patient outcomes and elevate the standard of care," said Nir Israeli, Co-founder and CEO of Sanoculis. "Clinical data from our prospective, single-arm study with a two-year follow-up indicate that MINT® is both safe and effective in lowering intraocular pressure (IOP), while also reducing the need for glaucoma medications."
Sanoculis plans a selective commercial pre-launch rollout of the MINT® technology later this year.
About Glaucoma
Glaucoma affects 76 million people worldwide—a number expected to rise to 112 million by 2040—and is the second leading cause of irreversible blindness globally. Most forms of glaucoma are chronic and, when left undetected or untreated, lead to irreversible vision loss. Early detection and treatment are essential for protecting against vision loss, which occurs when the optic nerve deteriorates, leading to progressive loss of visual field. Lowering IOP and reducing visual field progression is currently the only proven treatment for glaucoma. The current treatment paradigm typically begins with topical eye drops and may progress to laser therapy or minimally invasive glaucoma surgery (MIGS), before resorting to traditional, more invasive filtration surgery.
About Sanoculis
Sanoculis Ltd. is a company specializing in ophthalmic medical device technologies. Sanoculis has developed proprietary, stentless, minimally invasive solutions designed for performing sclerostomy and trabeculostomy during glaucoma angle surgeries. The company's mission is to deliver innovative, stent-free technology platforms that enhance the standard of care and improve outcomes for patients with glaucoma.
Contact:
Elad Shalev
VP of Global Marketing and Sales
elad@sanoculis.com
+972509827282
Video - https://www.youtube.com/watch?v=pEoCdMDAvS4&ab_channel=MINT2024
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