CorNeat KPro  

A revolutionary innovation in corneal replacement therapy

About Corneal Blindness 

Diseases affecting the cornea are a major cause of blindness worldwide. According to the World Health Organization, approximately 2 million new cases of corneal blindness are reported each year. Over 30 million people in the world are legally blind in one or both eyes from corneal injury and disease, while many more suffer from degraded visual acuity. A recent study published in JAMA Ophthalmology* assessed the shortage of corneas at one available cornea for 70 needed.

Several attempts to develop an artificial cornea have failed in creating robust, scalable and reliable solutions. As such, there exists an unmet need for an efficient, long-lasting and affordable solution to corneal pathology, injury and blindness, which would alleviate this suffering and disability and enable patients to fully exploit their vision potential. 

*Gain P, Jullienne R, He Z, et al. Global Survey of Corneal Transplantation and Eye Banking. JAMA Ophthalmol. 2016;134(2):167–173. doi:10.1001/jamaophthalmol.2015.4776

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Global Demand

World map showing the supply and demand of corneal transplantation in 148 countries

 

"Our survey globally quantified the considerable shortage of corneal graft tissue, with only one cornea available for 70 needed. Efforts to encourage cornea donation must continue in all countries, but it is also essential to develop alternative and/or complementary solutions, such as corneal bio-engineering."*

*Gain P, Jullienne R, He Z, et al. Global Survey of Corneal Transplantation and Eye Banking. JAMA Ophthalmol. 2016;134(2):167–173. doi:10.1001/jamaophthalmol.2015.4776

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CorNeat KPro Advantages 

CorNeat KPro is superior to keratoplasty and current keratoprosthetics in the following aspects

Optical Performance

Replicating optimal corneal optics

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Wide field of view

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Simplifying the surgical procedure via direct visualization while

enabling future procedures in a similar fashion

Healing & Retention

Device integrates to the eye wall using nano-fabric that imitates the native ECM

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Fast to heal

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Progressive integration

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Straight forward post-operation recovery

Scalability 

Relatively simple, 45-minute operation

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Affordable price

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No time constraints placed on scheduling of the implantation

Safety 

No need for tissue

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Cannot carry any infectious agent including COVID-19

CorNeat KPro

The CorNeat KPro is an artificial cornea, which provides a long-lasting medical solution for corneal blindness, pathology and injury. The CorNeat KPro implant is a patented synthetic cornea utilizing advanced cell technology to integrate artificial optics within resident ocular tissue. It is produced using nanoscale chemical engineering, which stimulates cellular growth.

 

Current biological solutions and previous KPros are either sutured to, or attempt integration with, the native corneal tissue – a tissue that lacks blood vessels and heals very poorly. The CorNeat KPro integrates underneath the conjunctiva, a vascularized site rich with fibroblasts, which heals quickly and vigorously.

The CorNeat KPro is combined with a novel and relatively simple surgical procedure to provide an efficient, therapeutic, and affordable remedy for millions of people with cornea-related visual impairments and is far superior to any available alternative. 

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Features, Surgical Kit and Procedure 

The CorNeat KPro implantation procedure is relatively short and simple when compared to other KPros and even when compared to keratoplasty. Unlike current procedures requiring delicate suturing of donor tissue to the patient’s native cornea, a process which can only be performed by very skilled and thoroughly trained specialists, the CorNeat KPro snaps into the patient’s trephined cornea and is then sutured to the eye using three non-degradable sutures. 

The surgical tools supplied as part of the implantation kit: the marker and the snapper, yield a systematic and accurate implantation process. This procedure is easy to teach and can be learned within a couple of days. The operation minimizes the time the eye's contents are exposed to the outside world - "open sky" - to less than one minute, significantly reducing associated risks.

The CorNeat KPro implant patented design is the result of an extensive, multidisciplinary (Physics, Chemistry, Biology) research and development process.  The device, and its wide aperture PMMA lens, provides unprecedented visual performance and a wide visual field. The KPro lens’ posterior side is designed to easily snap into a trephined cornea and maintain the eye’s integrity and as a result normal intraocular pressure, post-operation. The lens is surrounded by a non-degradable porous integrating skirt, which is implanted subconjunctivally. 

The skirt embeds itself into the sclera within weeks as it stimulates anchoring cellular growth. Grooves on the circumference of the lens are filled with porous material and as a result are colonized with tissue. This novel integration method of biological stitching further secures the device through its optical member thus ensuring reliable and quick healing, coupled with long-term retention.

 

Three pairs of suturing holes on the rim of the lens increase safety. These holes enable the ophthalmologist to secure the device quickly and easily to the eye. Suturing the device eases and shortens the implantation procedure and stabilizes both the lens and the skirt post-operation. This physical stability ensures progressive and uninterrupted bio-integration.

The CorNeat KPro lens is designed to enable post-operative ophthalmic examinations and subsequent anterior and posterior segment surgeries (i.e. cataract and retinal surgeries). This is achieved with four openings or “ports,” located on the rim of the lens, corresponding to the limbal zone. Four corresponding port indicators can be viewed through an ophthalmic microscope directing the surgeon to these port's locations. This is required as the ports are located and placed subconjunctivally. 

Being 100% synthetic, sterile, and composed of inert materials, the device is not expected to bear infectious agents or cause excessive inflammation. This will result in improved quality of life and more effective patient care.
 

Indications 

Failed keratoplasty 

Corneal indications not suitable for keratoplasty, such as: 

  • Herpes keratitis

  • Corneal degenerations

  • ICE syndrome

  • Aniridia

  • SJS

  • OCP

  • Alkali burns

  • Vascularized cornea

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Regulatory Path

CorNeat Vision designed, produced and tested several versions of the CorNeat KPro, successfully completing the preclinical phase. As part of this phase, a ground-breaking 6-months-long study, proved the device's safety.

 

The CorNeat KPro is planned to start clinical trials during the second half of 2020, toward FDA (510K) clearance (USA) and CE marking (Europe).

 

Given the limited indications and our aim to provide a solution for blind patients who are not candidates for keratoplasty or have failed one or more transplantations, the study toward CE marking and FDA (510K) clearance will encompass approximately 30 patients with a minimal follow-up period of 12 months. Given the apparent superiority over donor tissue, we are planning to conduct a study with broader indications including as first line treatment, which will enable us to expand the device's indications for use. At present, the device is expected to achieve the initial clearance in 2022.

In China, where there are over 5 million patients waiting for keratoplasty and only a few thousand transplantations a year, we are planning a study which will facilitate turning the CorNeat KPro into a primary solution for corneal blindness. The study is planned to start in 2021 and will include 60-70 local patients toward the NMPA (previously CFDA) approval (China).

 

The plans above are subject to regulatory approvals and requirements.

For more information:  clinicaltrials.gov

 
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Q&A

Where will the CorNeat KPro clinical trials take place?


The CorNeat KPro clinical trials are planned for the second half of 2020, initially in Israel, followed by Canada, USA, France and Netherlands, up to the beginning of 2021, and finally in China later that year.




When will the CorNeat KPro be available for use?


The planned KPro launch is set for 2022, most likely during the first half of the year.




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 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 to decrease the risk of progression of glaucoma.





Would a person with severe dry eye be a candidate for the CorNeat KPro implantation?


Initially we will treat patients with some tear production. With the accumulation of experience, we will collect the necessary evidence to encourage surgeons to tackle the most challenging and arid ophthalmic patients, suffering from alkali chemical burn, Stevens-Johnson Syndrome or ocular cicatricial pemphigus.




Would a person with Stevens-Johnson Syndrome be a candidate for the CorNeat KPro implantation?


See previous answer.




Would a person with herpes keratitis be a candidate for the CorNeat KPro implantation?


Yes, we believe that Herpes patients stand to gain a valid therapeutic modality, which is currently missing in the battery of clinical ophthalmic solutions.




Would a person with a scarred cornea be a candidate for the CorNeat KPro implantation?


Scarred, opaque and/or vascularized corneas are excellent candidates for the CorNeat KPro.




Would a person who had laser correction surgery be a candidate for the CorNeat KPro implantation?


Yes, laser correction does not interfere with the CorNeat KPro implantation procedure.




Would a person who had a corneal transplantation (one or more) which was/were rejected be a candidate for the CorNeat KPro implantation?


Yes, patients with failed corneal grafts are our ideal candidates for implantation.




What are the differences between the CorNeat KPro and the Boston KPro?


The Boston KPro utilizes a donor cornea to attach the synthetic lens to the eye. The bond between the optic (artificial lens) and the donor cornea erodes with time, creating hypotonicity and a port of entry for bacteria, usually leading to loss of the eye. In most areas of the world, tissue is scarce and procedural knowledge of corneal transplantation limits its scalability. The CorNeat KPro is completely synthetic and in animal implantations the bond between the device and the tissue has been shown to be strong and long-lasting. The CorNeat KPro is an off-the-shelf device, and therefore scalable. The Boston KPro provides a narrow field of view both for the patient and the physician. This limits the ability of the practitioner to follow up on the eye’s health and intervene in time. The CorNeat KPro has a wide field of view similar to the native cornea. This will allow regular and thorough follow-up, provide the patient with real-life optics and restore an aesthetic appearance. The Boston KPro is a temporary solution, which needs to be replaced once every few years, when all goes well, or it fatally damages the eye's visual potential through a variety of complications. The CorNeat KPro is engineered to be a permanent solution with robust integration into the eye’s tissues. Following implantation of the Boston KPro, access to the internal ocular compartments is blocked thus surgical procedures cannot be carried out. The CorNeat KPro is engineered to ease anterior chamber access following implantation. The bays on the optic’s rim enable anterior chamber access following implantation and will stay accessible throughout the patient’s life. Posterior chamber access is readily available through the device’s integrating element, which should stay accessible throughout life as well.





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