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
The CorNeat eShunt's outlet is uniquely placed in the intraconal space, a space with minimal fibrotic potential
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
Extends minimally invasive surgery to severe and refractory cases
Integral EverMatrix™ patch reduces inflammation and risk of tube exposure
Low risk of hypotony due to positive pressure around the outlet
Engineered to imitate the human physiologic, drainage pathways
Adaptive flow mirrors pressure elevation
Effective immediately post-op
Ease of Implantation
Implantation procedure can be completed in under 15 minutes
Integral EverMatrix™ patch relieves the need for additional, processed, or donor tissue
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.
The CorNeat eShunt is intended to reduce intraocular pressure in neovascular glaucoma or glaucoma where medical and conventional surgical treatments have failed.
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 second 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.
Where will the CorNeat KPro clinical trials take place?The CorNeat KPro clinical trials began in January 2021, initially in Israel, followed by Canada and France.
When will the CorNeat KPro be available for use?The planned CorNeat KPro launch is set for 2024.
What will the selection criteria be for patients for the CorNeat KPro implantation?Initially, the CorNeat KPro will be approved as a second-line treatment, only patients who lack a therapeutic alternative or have failed a corneal transplantation will be eligible for the procedure. Approval of the CorNeat KPro as a first-line treatment is a priority for CorNeat Vision and will follow shortly after the initial approval.
Would a person with keratoconus be a candidate for the CorNeat KPro implantation?Keratoconus patients are suitable candidates for corneal transplantation (keratoplasty) with positive long-term results. Therefore, they are not ideal candidates for primary implantation. Keratoconus will not be a hindrance in the CorNeat KPro implantation in any case of rejection of a transplant or other complications in corneal transplantation as a second-line treatment.
Would a person with a detached retina be a candidate for the CorNeat KPro implantation?Such a patient would not be a good candidate as the CorNeat KPro does not address the pathological aspect of this condition. Such a patient can only benefit from a KPro implantation as an aesthetic aid.
Would a person with glaucoma be a candidate for the CorNeat KPro implantation?Glaucoma is not a contraindication for the CorNeat KPro implantation. Glaucoma should be taken into account when planning the surgery as adjunct procedures might be necessary to improve follow-up of the implantation in order to decrease the risk of progression of glaucoma.