About Ophthalmic Reconstructive Surgery
Reconstructive surgery of the eye takes place following irreparable damage to the eye’s integrity. Such damage can result following trauma, iatrogenic damage (damage caused during a surgical procedure) or as a result of an inflammatory/connective tissue disease process. In these instances, the tissue can incur such damage that direct and immediate closure becomes impossible making patching the area with preserved and processed tissue the only treatment option.
CorNeat KPro
CorNeat EverPatch Advantages
Long-Lasting
Inert and non-degradable material
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Bio-mechanical integration coupled with a minor and progressively subsiding, inflammatory response
Ease of
Handling
Extremely easy to handle and suture
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Elastic and durable (cannot be torn by the sutures)
Safe
Synthetic and therefore cannot transmit disease
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Biocompatible
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Thin (100 microns), minimizing risk of dellen
Cost-Effective
Reduces operating time and eye bank costs
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Eliminates complexities related to the transportation and storage of biological materials
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Readily available, off-the-shelf, device
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Substantially longer shelf life than organic/degradable solutions
Aesthetic
Translucent when wet
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Hardly visible when implanted subconjunctivally
CorNeat EverPatch
The CorNeat EverPatch (scleral patch) is the first inert, synthetic and non-degradable tissue substitute for use in ophthalmic surgeries. It is poised to displace the use of donor and processed tissue, which eventually degrades and carries the risk of disease transmission.
The CorNeat EverPatch is composed of a non-woven, polymer matrix, which integrates with surrounding tissue and is intended to reinforce the sclera and aid the physical reconstruction of the ocular surface.
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“The ideal graft material should be long-lasting, sterile, immunologically inactive, cosmetically acceptable, and readily available,” states Seminars in Ophthalmology*. The CorNeat EverPatch was designed with these goals in mind.
*Bains U, Hoguet A. Aqueous Drainage Device Erosion: A Review of Rates, Risks, Prevention, and Repair. Semin Ophthalmol. 2018;33(1):1-10. doi: 10.1080/08820538.2017.1353805. Epub 2017 Dec 6. PMID: 29211548.
Indications
Covering irritating implants such as in glaucoma tube shunts or exposed sutures, displacing the need for preserved tissue/collagen
Covering tissue gaps/weaknesses, resulting from either traumatic, disease related or iatrogenic damage
Regulatory Path and Clearances
As of June 2023, the CorNeat EverPatch was granted FDA 510(k) clearance.
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Looking ahead, the company is working closely with its regulatory advisors to obtain CE Marking for the device. Work includes adjusting the company QMS and device history record in compliance with EU Medical Device Regulation, collecting post-market surveillance data, and performing limited clinical evaluation as required.
Additional Clinical Trials
A clinical trial evaluating the performance of the final configuration of the CorNeat EverPatch has completed enrollment in Tbilisi, Georgia. This trial, which began in September 2022, follows 12 patients implanted with the CorNeat EverPatch. To date no severe adverse events have been reported.
On the right you can see the CorNeat EverPatch implanted under the conjunctiva – nine months post-op.
First-in-Human (FIH) Implantation
The FIH implantation of the initial CorNeat EverPatch took place in December 2020 as part of a bilateral glaucoma tube shunt implantation. The surgery was conducted by Dr. Ike Ahmed at the Prism Eye Institute in Toronto, Canada.
The fact this patient underwent the same surgery in both eyes at the same time by the same surgeon presents a unique opportunity to compare the CorNeat EverPatch and current state of the art (scleral patch) – both used to conceal the shunt and protect the overlying conjunctival tissue.
At the top, you can see the eye implanted with the scleral patch and at the bottom, the eye implanted with the CorNeat EverPatch, both photos were taken two months post-implantation.
Besides the clear aesthetic advantages of the CorNeat EverPatch over the scleral (tissue) patch, the device's clinical advantages are very clear. While the conjunctival tissue overlaying the CorNeat EverPatch is healthy and quiet, congestion and inflammation is clearly visible over the scleral patch – an expected reaction to donor tissue.
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28 patients were implanted with the initial configuration of the CorNeat EverPatch with promising results, thus completing the FIH clinical trial.
Pre-Clinical Results
