In a lesser recognized pocket of the Innovation Quarter, there’s a knot of research buildings forming one of the world’s foremost hubs of regenerative medicine. Here, both academic and commercial parties have formed a neighborhood of regenerative medicine—research that focuses on healing or restoring tissue damaged by illness, age, or injury. These organizations collaborate and support each other, anchored by Wake Forest Institute of Regenerative Medicine (WFIRM), one of the most widely recognized leaders in regenerative medicine research.
One of these buildings is home to an innovation accelerator run by the RegenMed Development Organization (ReMDO), a non-profit dedicated to promoting regenerative medicine. The accelerator comprises an incubation space for biotech companies and down one long hall, you’ll find offices and wet lab space for companies doing some unbelievable things.
Nestled among startups studying the aging of stem cells in space (Axiom Space) and 3D printing live cells (Brinter), you’ll find a company that’s revolutionizing the landscape of organ preservation: BMI OrganBank.
You’ll never look at a kidney the same way again.
Imagine you’re very sick, and you’ve been told that the only thing that can help you is a kidney transplant. Maybe you don’t need to imagine–maybe that’s you or a family member or friend. Then imagine you get a call–after five years on a waitlist, there’s a kidney for you.
You probably feel like rejoicing, but you’re not over the hill yet. Even if a kidney is available, there are so many reasons that the kidney might not be transplanted. There’s a limited amount of time a kidney can be ex vivo (out of the body) before it dies, so it’s difficult to get everyone in the right place at the right time to make the switch. And even if the logistics work out, the transplant surgeon may reject the organ due to damage that happens during organ preservation or because it looks “iffy,” and there’s no objective way of determining the condition of the organ.
When you’re waiting for a kidney–or another organ–the wait can be unbearable or even terminal.
Here’s the organ transplant problem by the numbers.
- There are 110,000 people on waitlists for organs.
- 90,000 of those people are waiting for a kidney.
- People wait 3-5 years (or more) for a kidney.
- Only 25,000 kidneys get transplanted a year.
- Every year, around 4 million people in the U.S. die.
- 60% of Americans are registered organ donors.
You do the math. According to the Washington Post, there are more than 230,000 kidneys that could be transplanted to save more lives. Yet every day, at least 10 people die waiting for a kidney transplant.
Meet the company rewriting the organ preservation math.
Here’s the number that really makes the people at BMI OrganBank wild: 27% of donated kidneys are never transplanted. That was something that Carrie DiMarzio, Chief Executive Officer, and Robert Neusner, Chief Operating and Business Officer, could do something about.
Carrie DiMarzio was recruited by the founder of BMI OrganBank because of her work with another tech startup.
“Our goal is to bring the waitlist of transplant patients down, starting with those who need a kidney,” DiMarzio says.
In 2023, Robert Neusner was in talks with the company about coming on board when, inexplicably, he learned his daughter had just been diagnosed with polycystic kidney disease and was told that she may need a kidney transplant one day.
“I took the job,” Neusner says. “There doesn’t need to be a waitlist for a kidney, and we’re going to make it go away.”
What is regenerative medicine? Read a quick description and find out how organ preservation fits into the larger equation.
While some aspects of regenerative medicine may sound like science fiction, the applications of this field are intensely practical. The goal of regenerative medicine is to develop new methods to heal tissues and organs and restore function lost due to illness, aging, or injury. New treatments like tissue engineering and cell therapies help the body “regenerate” its tissues and functions, hence the name.
So how does organ preservation fit into this regenerative medicine picture? Donor organs are damaged–from a lifetime of use or even from the removal and transport of the tissues. Many organs are discarded due to this damage, but BMI OrganBank is focused on rehabilitating these organs and restoring their function to benefit transplant recipients.
“Our technologies prevent deterioration and even show promise in reconditioning the organ and turning back the clock on the age of the organ,” Bob Neusner says.
In addition to helping “regenerate” human organs, BMI’s work could play a role in transferring lab grown organs into humans when that technology becomes widely available.
Why do so many kidneys get discarded, anyway?
Transplants of organs only happen when very specific (and stringent) standards are met. There is no way for transplant surgeons to objectively determine the state of a kidney before transplanting it, so if there’s the slightest hint or concern about the condition of an organ, it’s not transplanted.
“Many of the kidneys that are literally being thrown in the trash are probably good kidneys, life-saving kidneys,” Neusner says. “You just can’t tell today which ones are good kidneys.”
Current methods and technology for sustaining organs between donor and recipient also fail in two other ways.
First, there’s a very limited amount of time that kidneys and other organs are viable for transplant. Currently, a kidney might have 10-15 hours out of the body, and that makes the distance it can travel to a patient very short as well as put pressure on the logistics of assembling a transplant team.
Second, the very method of organ preservation–cooling the organ and putting it on ice–can cause damage. Organ preservation methods reduce the temperature of the organ and put it into a hibernation state, which prevents cell death for a time, but also causes the organ to deteriorate. The kidney then has to be warmed up when it’s put in a body.
“There’s no way to tell how a kidney will function other than implanting it in a patient and waiting,” DiMarzio says. “Being able to assess how a kidney is functioning before implanting would be huge.”
How does BMI OrganBank address organ preservation problems?
BMI OrganBank has a pipeline of products in development, including what they call the OrganBank Transport, a organ preservation unit that maintains kidney function and extends transport time for 24 hours or longer.
What makes OrganBank Transport so different from current solutions? A few things, but the biggest is that the organ spends no time on ice. The unit keeps the organ warm and simulates the role of the heart so that the organ keeps functioning and avoids deterioration.
The scientists and circulatory experts at BMI OrganBank have created a process for sustaining organs with a one-of-a-kind solution (think of it like organ food) that circulates through the organ in the unit, delivering oxygen and nutrients.
“[Our proprietary solution] sounds a little bit like a weird version of Gatorade, but it’s very important, allowing the cells to stay alive,” Neusner says.
Being warm and circulating life-fueling fluids greatly expands the time that an organ stays viable, giving time for transport and coordinating staff.
The unit also provides data on the condition of the organs. By keeping track of the organ’s vitals, so to speak, transplant surgeons have actual data to work with to make decisions, not just a visual examination of the organ.
Here’s the next big thing in BMI OrganBank’s mission to bring down the transplant waitlist.
BMI OrganBank recently announced a new partnership with Atrium Health Abdominal Transplant Center, one of the busiest transplant centers in North Carolina, to begin clinical research in Charlotte, NC in 2024.
“With more than 27% of donated kidneys in the U.S. not used for various medical and logistical reasons and constantly rising wait times on the national kidney transplant list, we face an urgent need,” Dionisios Vrochides, MD, PhD, says.
Vrochides is Chief of Liver Transplant Oncology Section and Vice Chairman of the Department of Surgery at Carolinas Medical Center, Atrium Health, and he is helping to lead the partnership with Atrium Health. He first found BMI OrganBank through a working relationship with that regenerative medicine neighborhood in the Innovation Quarter mentioned earlier—a testament to the power of proximity. He is partnering with BMI OrganBank because he believes their technology can change the status quo.
“Their innovative approach to increasing the pool of kidney grafts available for transplantation has the ability to disrupt the current status of care for patients with chronic renal failure,” Vrochides says. “If our collaboration proves the value of the technology, the impact on patient outcomes will undoubtedly be profound and life-changing [everywhere].”
But BMI OrganBank has more on the brain than just kidneys.
So far, we’ve just talked about kidneys, but BMI OrganBank is not a one-trick pony. The products in the company’s pipeline can also support other organs (like liver, lungs and intestine) as well as tissues.
The company also has other products in development, such as OrganBank Nest, a docking station that can be used at organ banks or transplant centers to sustain multiple organs, and Organ IQ, an application that will provide remote connectivity for surgeons to check in on the condition of the organ at any time.
“This is the situation here on the ground today, but as technology and innovation grows, our device can support those future needs as well,” Neusner says.
Being a part of the regenerative medicine community, BMI OrganBank is also preparing for the future of organ transplant, one where organs are printed or grown in a lab.
“It’s part of why we became the first tenant of the ReMDO Innovation Accelerator,” DiMarzio adds. “This is where the future of regenerative medicine is happening.”
