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FDA grants 510(k) clearance for the first synthetic, non-degradable tissue sub for ophthalmic surgery

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CorNeat Vision has received 510(k) clearance from the FDA for the EverPatch, a synthetic tissue substitute for use in ophthalmic surgeries.

Give me a refresh on this company.

Based in Israel, CorNeat Vision is a clinical-stage, medical device company with a product portfolio of biomimetic medical implants and technology.

The company's core technology is the CorNeat EverMatrix, a patented, core tissue-integrating material platform that is currently the only synthetic non-degradable patch material in ocular surgery.

Aside from the CorNeat EverPatch, the company boasts other products including the CorNeat gPatch (for permanent periodontal regeneration membrane), CorNeat KPro (for artificial cornea), and CorNeat eShunt (a glaucoma drainage device).

Tell me more about this core technology.

The EverMatrix is designed to displace the use of tissue and degradable biological scaffolds that are used in surgical procedures in various fields of medicine.

It is also able to be produced in 2D and 3D forms, allowing for:

  • Physical attachment of implants to tissue
  • Implant concealment
  • Soft tissue repair and permanent reinforcement
  • Membrane and tissue barrier fabrication

To note, the EverPatch is the first device to utilize this technology.

Now talk about the EverPatch.

The CorNeat EverPatch is the world’s first inert, synthetic and non-degradable tissue that aims to displace the use of donor and processed tissue often used in ocular surgeries.

The scleral patch is comprised of a non-woven, polymer matrix (the EverMatrix) that combines with surrounding tissue in order to support the scleral and assist in reconstructing the ocular surface (see below).

CorNeat EverPatch

How does it compare to other patch tissue?

According to Gilad Litvin, MD, CorNeat Vision’s CMO and co-founder, the ophthalmic patch is significantly thinner than processed patch tissue, provides better handling, and has holes that enable accurate positioning and anchoring. “These holes also facilitated direct conjunctival adhesion to the scleral[,] thus supporting its bio-integration,” Litvin stated.

Where can I find it?

Per CorNeat Vision, the EverPatch is being launched in top ophthalmic centers across the United States starting in Q3 2023.

The company plans to expand rollout later in 2023.


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