Mike Curtis, President & CEO, eGenesis

In an interview with Invest:, Mike Curtis, president and CEO of eGenesis, talked about the company’s mission to address the organ shortage crisis by pioneering xenotransplantation. Recent achievements include the first-ever transgenic porcine kidney transplant in a living person. With products targeting end-stage kidney, acute liver, and pediatric heart failure, eGenesis aims to advance its portfolio and expand clinical trials. 

Can you provide an overview of eGenesis and some of your latest achievements?

We have the vision of transforming the treatment of solid organ failure and really revolutionizing how we address the organ shortage problem in the United States. At any one time, there are over 100,000 patients on a transplant waiting list with 17 patients dying everyday waiting for organs and an even larger population of patients that are not on a waiting list but could benefit from a transplant. We have been working on creating this renewable supply of organs for the past six or seven years and most recently we did the first-ever transgenic porcine kidney transplant in a living person on March 16, 2024. We transplanted one of our products in a patient who was suffering from end-stage kidney failure. The patient passed away 51-days post-transplant after suffering a cardiovascular event unrelated to the kidney transplant. The kidney was functioning well at the time of their death. We are incredibily grateful to the patient for having the courage to take this important step for all patients suffering from end-stage kidney failure.   

What are some next steps for your team?

We continue to advance our full portfolio and have products for the treatment of end-stage kidney failure, acute liver failure, and pediatric heart failure. We will continue to do transplants in the kidney setting and before the end of the year we intend to do the first liver perfusion to treat a patient suffering from acute chronic liver failure and later this year we hope to do our first transplant for pediatric heart failure. The first transplant in the kidney setting has really opened the door for a broad effort across all of our programs. 

What have been some of the biggest challenges? 

I think what we are seeing is we have to manage immunosuppression and monitor the recovery process. Every day is another day which is the exciting part of transplant because the patients we are studying have run out of options and are on the verge of death in most cases so we are excited about what we have been able to accomplish. 

Can you talk about the importance of collaboration involved in these efforts?

One of the reasons I joined four years ago is the fact that this idea was pioneered by human transplant surgeons, people that live everyday in this world of organ shortages. They have been looking for alternatives since the 1950s so most of the discoveries have been made in an academic setting. The collaboration between academics and industry is paramount because we couldn’t accomplish anything without each other. Most of the work we have done was primarily on monkeys to show that our products could give long term outcomes. This past fall we published a series of transplants with monkeys showing we could get over two years of post-transplant survival which set the foundation we have with the treatment team and Mass General.

There is also a strong collaboration with the regulators at the U.S. Food and Drug Administration (FDA). We have been speaking with them for the past five years to introduce them to our technology and get their feedback. Because this is a new technology in an area of medicine the FDA is not super involved in it is new for both parties but their input and collaboration is critical for us to bring this to patients. The relationship was really important for getting agreement to do this first transplant.  

What challenges are you facing in regards to the economy?

Overall, we spend as a society about $100,000 a year to support and maintain patients on chronic dialysis. Patients can be on dialysis for upward of 15 years so the cost economically is significant. Additionally patient health deteriorates during that process leading to poor outcomes. When you think about the solution we are providing we are trading off that cost while also bringing better outcomes to patients and improving quality of life.  

What is your approach to ensure long term financial sustainability? 

We were founded with technology we licensed based on a discovery made out of Harvard. There are initial investors invested in this idea of bringing it to patients and we consistently need to show progress as a company. We have to understand regulatory risk and the path to commercialization and all those things lead to attracting investor interest. The progress we have made has increased interest in the space and we have taken a significant amount of risk out of this new technology and bringing more potential investors into the space. 

What technological advancements are being incorporated into your business? 

One area of technologythat is often underappreciated in our field is what we refer to as next generation sequencing or genomics. It allows us to understand the patient and also the genome of our edited animals. Ten years ago that would have been impossible, so the ability to analyze the entire genome in a few hours is a technology critical for us to make advancements. 

How are you addressing labor shortages?

It’s a robust market here in Cambridge but I think what helps us is our cutting-edge technology, doing something new, and the team that we have already has created success. One of the reasons that we located our research headquarters in Cambridge was the access to a large pool of experienced and talented scientists. However it seems we can never hire as fast as we would like especially as we grow. 

What do you see as the future of the organization within the next decade? 

What we have shown in the past couple of months is that in the right patient population we are going to see additional transplants done and the first approval of products. The long vision for our platform is to produce organs that don’t require chronic immunosuppression and these first products that we bring to patients will inform what else we need to do in order to accomplish that. We will start to see routine use of these products in patients with end stage organ failure in the next five to 10 years. 

What advice do you have for young professionals aspiring to enter the field? 

The first is to keep an open mind and to view all these opportunities as very valuable experiences. When I joined this company four years ago, we had a solid plan and vision but you never know if you are going to get there. I think a lot of the innovation culture we built in Cambridge allows people to try, fail, and try again. It is rarely a straight line and opportunity can arise in the failure you encounter

What are your top priorities moving forward?

What we have already done in the past two months has opened the door to bring our products into the clinic to treat patients. Our goal is to do more of that to bring treatment to more patients and create a data set that allows us to go after an approval. We want to move forward to the expanded access study portion in order to bring our programs to the pediatric population this year and bring these life saving therapies to a large number of patients. 

What we have already shown is that our type of transplantation is here and we are going to show how powerful it is to solve organ shortage and help patients suffering from organ failure.