CorNeat eShunt 

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. 

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:         

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)

The CorNeat eShunt has successfully passed initial bench tests and animal trials demonstrating seamless integration and the ability to reduce and regulate intraocular pressure.

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The CorNeat eShunt is planned to enter a six-months GLP animal trial at the end of 2022 and will then enter the clinical phase in 2023, 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.

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CorNeat eShunt device marketing is pending regulatory approvals.