Bernie’s Quarterly Update – November 2024

November 13, 2024

A message from Bernie Iliakis, President & CEO of CorneaGen

We’re nearing the end of another year, having just wrapped AAO 2024—things are busy as always at CorneaGen, so I’m excited to share a few third quarter highlights and upcoming opportunities.

Industry events and participation

CorneaGen attended ESCRS in September and AAO in October, meeting with partners, sharing innovations, and showcasing our solutions.  Much of the talk was around the hot topic of Corneal Allogenic Intrastromal Ring Segments (CAIRS) and our customized solution, CTAK.

Corneal Tissue Addition Keratoplasty (CTAK) continues to have immense interest. It was our headliner for AAO, with 111 surgeons trained in wet labs throughout the course of the event. We have more than 300 surgeons interested in the solution, with nearly 165 on board and ready to submit patients. Dr. Peter Hersh (Teaneck, NJ), creator of CTAK, and Dr. Brandon Ayres (Wills Eye Hospital, Philadelphia) joined us at AAO to present on CTAK benefits for patients, sharing how the procedure can reshape the cornea and return sight. This innovative solution to corneal contouring represents a true treatment advancement for keratoconic eyes. We continue to be very excited about the ongoing work that is changing the lives of those affected by keratoconus and maximizing the gift of eye donation.

Also, at AAO, we were proud to highlight our EndoSerter-PL solution, demonstrating how it redefines DSEK. Dr. Yassine Daoud (Wilmer Eye Institute, Baltimore) led this discussion in the CorneaGen booth, presenting the benefits of and demonstrating pre-loaded DSEK.

We’re seeing growing international interest in CorneaGen solutions, and the work we’re doing with partners is infinitely rewarding. From the advancement of CTAK through collaborations with CTAK LLC, Ziemer, and Corza to the work with Iantrek Inc., whereby we assemble, package, and distribute its CycloPen, these partnerships make industry innovation possible.

I encourage all interested in learning more about CTAK to join me on Thursday, November 20th as I host a webinar on CTAK, presented by Dr. David Hardten (Minnesota Eye Consultants) and Dr. Elizabeth Davis (Minnesota Eye Consultants). Together, these doctors have performed over 100 CTAK procedures and they are ready to share their surgical pearls! You can register here.

Industry headwinds and developments

This year, the FDA has placed an increasing focus on tissue/eye donors with a notation of sepsis in their medical record. This is likely due to two recent tuberculosis infections that were linked to bone grafts. This has led to some eye banks being cited by the FDA for not determining donors as ineligible for transplant if there is documentation of sepsis in the medical record.

This can and already has significantly impacted the supply of ocular donor tissue for transplant in the US and abroad. It is possible final FDA guidance will require ruling out any donor with a notation of sepsis during their hospital stay. However, it is important to point out infectious disease consultants, who review a potential donor’s medical chart, as well as a Medical Director or Medical Director Designee, have always been part of making the final determination on eligibility and the track record of safety in corneal transplants is extremely high. We’re expecting additional FDA guidance soon, so more to come.

At CorneaGen, we’re well positioned and continue to maximize the gift, so we can continue to serve surgeons and patients with safe/quality tissue.

Industry conversations and discussion

I want to highlight CAKE Issue 24 – The Cornea Issue, which included CorneaGen commentary on the important role for-profits play in the eye banking industry. As you know, CorneaGen is very proud of the work we and other for-profit organizations have done to advance cornea care for the good of patients, surgeons, and the industry. We know our significant innovations (e.g. cell therapy) are possible only through a for-profit model, investor capital, and industry partnerships, as evidenced by the next-generation solutions and partnerships we’re talking about here in this message. I encourage you to read the article, starting on page 33, and know that CorneaGen remains committed to serving patients affected by corneal disease.

I close on a note of appreciation to everyone involved in supporting CorneaGen’s mission, and I look forward to finishing another year strong in 2024.