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.

Bernie’s Quarterly Update – July 2024

July 30, 2024

A message from Bernie Iliakis, President & CEO of CorneaGen

As we close the second quarter of 2024, we’re incredibly proud at CorneaGen to have launched commercial availability of Corneal Tissue Addition for Keratoplasty (CTAK). An innovative solution to corneal contouring, CTAK is a true treatment advancement for keratoconic eyes—providing patient ready, gamma-irradiated sterile, non-immunogenic corneal tissue segments. We couldn’t be more excited about this new opportunity to change the lives of those affected by keratoconus, while also honoring and making the most of each corneal donation.

And we don’t do any of this alone—with ongoing innovations brought to the market by strong partnerships, I’m pleased to share more about what CorneaGen has achieved in the last few months.

Innovations in corneal care

CTAK co-inventors include Drs. Peter Hersh, Steven Greenstein, and John Gelles. More than 150 successful surgeries have been completed to date, and we have 30 active surgeons using the solution. Just one recent testimonial includes:

“Following a CTAK procedure, patients can experience a ‘wow’ effect with their vision. We have seen immediate impressive improvements in best corrected and uncorrected vision. This immediate improvement at the first follow-up is an exciting experience for those dealing with Keratoconus.” – Dr. William Wiley, Medical Director, Cleveland Eye Clinic Division of Midwest Vision Partners

There’s been a lot of focus around corneal allogenic intrastromal ring segments (CAIRS) in the last few years and even growing international interest in a solution such as CTAK. We want to encourage everyone interested to reach out, as we continue delivering CTAK to the market, and don’t miss the webinar we’re hosting on August 6^th at 6pm Pacific, highlighting the solution.

Partnerships and philanthropy

Organizational partnerships that led to the creation of CTAK include CTAK LLC and Ziemer, and we have many others. CorneaGen has a long history with Geuder AG, as the distributor of their glass cannula used for DMEK surgery. We’re continuing to grow in the glaucoma space with collaborations like Iantrek Inc., whereby we assemble, package, and distribute the newly launched CycloPen, which utilizes scleral tissue for microinvasive glaucoma surgery (MIGS). CorneaGen’s collaborations to advance treatments, as well as efforts to provide sterile grafts for glaucoma and cornea surgeries through our Long-Term Tissue program, continue to be world class in the industry.

And I wanted to highlight CorneaGen’s Jared Young, our VP of Sales and Marketing, on his co-founding of the Trillium Vision Foundation. As this organization helps restore vision globally through a community of people and partners, CorneaGen is proud to support their philanthropic work. Watch the link below for coverage of their most recent trip to San Salvador.

https://eyewire.news/tv/trillium-vision-foundation.

Growth and expansion

In closing, I also wanted to make note of CorneaGen’s growing presence in California and Florida. Announced earlier this year, CorneaGen expanded eye recovery and processing services of donor tissue for facilities throughout California. We are in the midst of facility expansion in the Bay Area and Orlando, growing our team in both locations. We close a strong and eventful first half of 2024 with significant impact in the ophthalmic space.

Thank you as always to our surgeons and partners for helping support CorneaGen’s mission. I look forward to connecting on our progress next quarter.

Bernie’s Quarterly Update – June 2023

June 26, 2023

We’re halfway through 2023 and happy about how things are going and what the future holds. We have enjoyed a great six months of growth beyond our forecast. Our ongoing work to build innovative solutions, foster industry relationships, and strengthen our team and company culture continues. Here are several successes and/or opportunities I’m most proud of as we close the second quarter.

Promoting our innovations

CorneaGen was in full force at ASCRS 2023 in May, where we had the chance to celebrate another milestone for the EndoSerter-PL. Now in the hands of more than 150 surgeons, the EndoSerter-PL has been used in over 1,000 successful surgeries. The product keeps proving itself as a next generation device, improving efficiency in the O.R. by helping perform DSAEK surgery with precision. We also previewed our Corneal Tissue Addition for Keratoplasty (CTAK) solution which offers an exciting option for the treatment of keratoconic eyes and is now starting clinical trials. While we enjoyed great booth traffic throughout the event, it was the CTAK preview that earned the most interest, and we’ll have more to share at AAO later this year. And one more ASCRS note, the subspecialty day was incredible this year, with so many innovative developments underway that will transform this industry. We’ve heard about the potential of disruptive innovations such as cell therapy and artificial corneas for years…now they’re here!

Partnerships in the industry and patient access

 We’re still forging new relationships and strengthening existing ones across the eye/tissue donation profession. We continue to formalize mutually beneficial arrangements with our partner eye banks to maximize the quality and quantity of corneal tissue available. It was great to interact with many of these colleague at the EBAA meeting in Dallas recently.  Whether it be more integrated tissue sharing, access to our innovative devices, or improving eye recovery in certain geographies, we are thinking “outside the box” when it comes to working with our trusted donation partners.

People are our passion

CorneaGen recently congratulated Chief Talent Management Officer Gretchen Coker on her semi-retirement after 14 years with us. And while we’re sad to see Gretchen go, we’re thrilled to welcome Heather Smith, taking over the HR role. Heather brings a wealth of experience, joining us from A Place for Mom, where she served as their Director of Human Resources. We’re also coordinating our next educational opportunity for Fellows, preparing to bring 14 surgeons to Seattle to learn about best practices in the field. And finally, the reason we’re in this industry, doing this work—patients. In always seeking to honor a donor’s gift, I wanted to share a news story about a donation from 2019. In this clip, Kayla’s family shared how they worked to make their daughter’s gift create positive change in their community years later.

As we close, I reaffirm our mission. CorneaGen remains committed to providing the highest quality donor tissue, unparalleled service, and superior products. We have much more to do in the second half of 2023, and I can’t wait to share.

Bernie’s Quarterly Update – December 2022

December 19, 2022

As we near the end of a very strong quarter and wrap up yet another year, all of us at CorneaGen pause to wish all of you the happiest of holidays. The collaboration and team spirit, both internal and external, are what made 2022 successful. Together, we reflect on what we’ve achieved and look to the year ahead, preparing to take advantage of ongoing and new opportunities to deliver sight-restoring corneal care to patients.

Here are just a few reasons to celebrate.

Product innovations this year and next…

CorneaGen launched the EndoSerter-PL at ASCRS, and we had another impressive showing of this FDA approved DSAEK solution at AAO—our best AAO ever. We had record booth attendance, meeting up with more surgeons and key opinion leaders than at any previous event. The EndoSerter-PL has been used in hundreds of surgeries and counting, as we get it in the hands of more and more surgeons. We’re also very excited for a couple of new product launches planned for 2023. Much more to come soon.

Teams who worked tirelessly…

With shortages in storage media and subsequent uneven tissue supply, we all faced a lot. Yet despite the issues, I saw endless can-do and creativity in working to solve these challenges. In the end and in collaboration with of all our Eye Bank and OPO partners, we finished Q4 very strong, delivering at yearend a high volume of sight restoring grafts to surgeons and patients.

Partnering with surgeons and industry leaders…

It was rewarding to reignite our Eye Bank Experience Program and host fellows again in person, helping educate our future leaders in cornea/anterior segment. We’ll keep offering and promoting educational pathways in the year ahead. Also, we’re happy to welcome Jane Rady back to our board. Her wisdom and experience in corporate ophthalmology greatly enhances our board and CorneaGen governance. Finally, I want to celebrate the gratis tissue CorneaGen provided for our surgeon partners’ mission trips this year—176 tissue donations from the beginning of 2022 through Nov 30, including for the WakeECHO mission below.

After a long hiatus due to COVID, WakeECHO Brigade #10 traveled to Honduras in October to provide cataract, cornea, and subspecialty surgery, as well as ophthalmology consultations to those in need.</font size>

Challenges surmounted in the industry at large…

We have been engaging eye banks and donation partners in new and meaningful ways. Consolidation continues, and it’s by strengthening relationships with these partners that we raise awareness and expand access to our innovative services and technologies for surgeons and their patients around the country. We’re developing best practices to shine a brighter light on corneal transplant reimbursement. We will expand this impactful program in 2023. And as always, I expect there will be many more prospects to partner on in 2023, improving awareness, education, and tissue supply for everyone.

On a closing note, I want to highlight the reason we do what we do. At CorneaGen, we remain committed to providing the highest quality donor tissue, unparalleled service, and superior products—all the while, we never forget the donors, their families and their final gifts, honoring the sacred process of eye, organ, and tissue donation.

Here’s to 2022, a Happy Holidays, and a very Happy New Year to all!

Sincerely,

Bernie Iliakis, President and CEO