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
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
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
Safe
No need for tissue
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Cannot carry any infectious agent including COVID-19
CorNeat KPro
The CorNeat KPro is a synthetic cornea, keratoprosthesis (KPro), 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 (keratoplasty), 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, the white part of the eye, a 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.
Features and Surgical Procedure
The CorNeat KPro implantation procedure is relatively short and simple when compared to other KPros and even keratoplasty (a corneal transplant). 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 process itself minimizes the time the eye is trephined and open (also known as “open sky”) to less than one minute – significantly reducing the risks involved.
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 enabled by four openings or “ports,” located on the rim of the lens, placed over the limbus.
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:
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Herpes keratitis
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Corneal degenerations
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ICE syndrome
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Aniridia
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SJS
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OCP
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Alkali burns
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Vascularized cornea
Regulatory Path
CorNeat Vision designed, produced and tested several versions of the CorNeat KPro, successfully completing the pre-clinical phase which included a groundbreaking 6-months-long study, successfully proving its safety.
The first-in-human (FIH) clinical trial for the CorNeat KPro took place on January 2021. The surgery was conducted by Prof. Irit Bahar at Rabin Medical Center, Israel, working toward FDA (510K) clearance (USA) and CE marking (Europe).
Given the apparent superiority over donor tissue, the company is planning to conduct a study with broader indications including as first line treatment, which will enable it 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, CorNeat Vision is 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).
Planned clinical sites and status:
Israel, Petah Tikva
Rabin Medical Center – Beilinson
Status: Recruiting
Contact: Hilla German l tel: +972-3-937-6100 l e-mail: eyeclinic@clalit.org.il
United States, California
UCLA – The Jules Stein Eye Institute
Status: Not yet recruiting
Contact: Ellen Pascual l tel: +1-310-794-5592 l e-mail: pascual@jsei.ucla.edu
United States, Kentucky
Cincinnati Eye Institute
Status: Not yet recruiting
Contact: Katie Hogeback l tel: +1-859-331-9000 ext. 4517 l e-mail: khogeback@cvphealth.com
Canada, British Columbia
University of British Columbia
Status: Not yet recruiting
Contact: Aleksandra Kuzmanovia l tel: +1-604-875-4555 l e-mail: akuzmanovic@shaw.ca
Canada, Ontario
UHN – University Health Network
Status: Not yet recruiting
Contact: Olivera Sutakovic l e-mail: olivera.sutakovic@uhn.ca
France, Paris
Hospital Foundation Adolphe De Rothschild
Status: Not yet recruiting
Contact: Patrick Vachey l tel: +33-14-803-6433 l e-mail: pvachey@for.paris
France, Montpellier
CHU de Montpellier
Status: Not yet recruiting
Contact: Hannah Crowdy l tel: +33-04-67-33-79-62 l e-mail: h-CROWDY@chu-montpellier.fr
Netherlands, Amsterdam
Amsterdam UMC
Status: Not yet recruiting
Contact: Monique Wezel l tel: +31-20-566-8618 l e-mail: m.wezel@amsterdamumc.nl
Netherlands, Maastricht
Maastricht UMC+
Status: Not yet recruiting
The plans above are subject to regulatory approvals and requirements.
For more information about clinical trials please visit clinicaltrials.gov.
Product Animation
Q&A
Where will the CorNeat KPro clinical trials take place?
The CorNeat KPro began clinical trials during the month of January 2021, at Rabin Medical Center, Israel, with the first-in-human implantation. It will be followed by Canada, USA, France and Netherlands and finally in China later this 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 (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 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.
