About Glaucoma
Glaucoma is a disease of the eye's optic nerve that impacts the lives of about 80 million people globally. Damage to the optic nerve takes place when fluid pressure builds up in the front of the eye (the anterior chamber). Excess fluid, called the aqueous humor, increases the eye's intraocular pressure which in turn damages the optic nerve. This damage leads to partial yet gradual loss of the visual field, usually starting from the periphery but eventually leading to the loss of central vision and blindness.
Current treatment modalities aim to control intraocular pressure by either reducing the aqueous humor production or increasing its drainage/absorption. These include drops, laser surgery, MIGS (Minimally Invasive Glaucoma Shunts), incisional surgery, such as trabeculectomy, and glaucoma shunts. All current treatment options have failed to provide a reliable long-term solution for severe and refractory glaucoma patients.
CorNeat eShunt Advantages
Everlasting
The CorNeat eShunt's outlet is uniquely placed in the intraconal space, a space with minimal fibrotic potential
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Scarring is the major cause of failure of trabeculectomy and existing shunts, which clog at a rate of 10-20% a year.
All relieve excessive fluid in the subconjunctival space
Deterministic
Engineered to imitate the human physiologic, drainage pathways
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Adaptive flow mirrors pressure elevation
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Effective immediately post-op
Ease of Implantation
Implantation procedure can be completed in under 15 minutes
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Integral EverMatrix™ patch relieves the need for additional, processed or donor tissue
Safe
Extends minimally invasive surgery to severe and refractory cases
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Integral EverMatrix™ patch reduces inflammation and risk of tube exposure
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Low risk of hypotony due to positive pressure around the outlet
CorNeat eShunt
The CorNeat eShunt is determined to revolutionize the treatment of glaucoma. It is designed to regulate the intraocular pressure and addresses the shortcomings of existing solutions. The CorNeat eShunt is efficacious and stable immediately post-op, as resistance to flow is dictated by its inlet and tube design and not by a valve or scarring around the outlet. The CorNeat eShunt outlet is uniquely positioned in the intraconal space, an area that does not scar and clog over time. The positive pressure (approx. 4mmHg) in this area reduces the risk of hypotony. The fat in the intraconal space can absorb the drained aqueous humour, without creating a bleb. The device seamlessly integrates with the ocular tissue using an integral tissue-integrating patch. This significantly shortens and simplifies the surgical procedure and minimizes the risk of tube exposure.
In vivo tests: a 6-week preclinical study (integration, IOP regulation, drainage concept) was completed with promising results:
Implantation procedure takes approx. 10 minutes
25% reduction in IOP
Histopathological proof of device integration with minimal
inflammatory response
Device materials are biocompatible: biocompatibility tests
overlap with the CorNeat KPro
Indications
The CorNeat eShunt is intended to reduce intraocular pressure in neovascular glaucoma or glaucoma where medical and conventional surgical treatments have failed.
Features
Inlet and lumen (regulating pressure)
Provides deterministic IOP: Resistance to flow imitates physiological outflow facility
Outlet (location)
Prolonged patency: the CorNeat eShunt's outlet is uniquely positioned deep within the orbit where there is mostly fat and minimal fibrotic ability, hence less likely to clog
Integral Patch
Biologically integrates with surrounding tissue: leveraging the CorNeat EverMatrix™ significantly shortens procedure
Integral Patch
Inlet and lumen
Outlet (location)
Product Animation
Regulatory Path
The CorNeat eShunt has successfully passed initial bench tests and animal trials demonstrating seamless integration and the ability to reduce and regulate intraocular pressure.
The CorNeat eShunt is planned to enter a six-months GLP animal trial during the first half of 2023 and will then enter the clinical phase, towards FDA 510(k) clearance and CE Marking with the following indications: to reduce intraocular pressure in neovascular glaucoma or glaucoma where medical and conventional surgical treatments have failed. The planned clinical study will include at least 50 patients and a follow-up period of one year.
CorNeat eShunt device marketing is pending regulatory approvals.