Signals From [Transplant] - PT02: The Opportunity

12 Signals that will leave you feeling optimistic about the future of this space

Aug 22, 2023

Welcome back to Signals From [Space], the place to discover what's next in healthcare technology— and who’s building it — one [space] at a time. I’m a founder and patient sharing my curiosities and earned wisdom along the way.

Today we’re going to explore 12 Signals across three major themes where the future of organ transplant is unfolding (and accelerating).

Themes include: (1) increasing organ availability; (2) improving accessibility & safety; and (3) enhancing care beyond the OR.

ICYMI

In Part 1 of this series we learned about the Organ Transplant Landscape, from the first successful kidney transplant to record-setting growth in 2022.

Signals From [Transplantation] - Part 1: The Landscape

Tim Fitzpatrick

August 21, 2023

Read full story

Signals

Organ Availability

1. Amplifying Organ Donation Awareness and Engagement

Raising public consciousness about the critical need for organ donations, thereby boosting donor registration rates and ultimately increasing the organ supply. In each of the past 12 years, new annual records have been set in the number of deceased donors nationwide. New programs aim to increase the number of living donors as well. You may be familiar with paired donation, or kidney exchanges, where living donor kidneys are swapped so two recipients receive a compatible transplant when their intended donors were not matches. There have been over 11,000 paired donations since the first one was performed at Rhode Island Hospital in 2000.1

Examples: Donate Life America, Transplant Life Foundation, LifeGift, LiveOnNY, Organize, United Network for Organ Sharing (UNOS), Kidney Paired Donation Pilot Project

2. Enhancing Patient Knowledge Across the Transplant Care Journey

Empowering patients with knowledge and resources to navigate their transplant journey, from evaluation to post-transplant care. Results from a 2019 study published in Transplantation suggest a 15-item Knowledge Assessment of Renal Transplantation (KART) measure can be used to help plan appropriate interventions and support transplant decision-making, based on results from a sample of 1,294 patients with kidney failure.2

Examples: Lyfebulb, Transplant Unwrapped, IKONA

3. The Growth of Regenerative Medicine and Bioengineering

This includes a variety of approaches, such as using stem cells to grow new cells, delivering specific types of cells or cell products to diseased tissues or organs to improve their function or induce healing, and using therapies that trigger the body's own repair mechanisms. In each of these cases, the hope is we can reduce our dependence on new organs by repairing the ones we already have.

“18 Days to Antibody Library” | Credit: Prellis Biologics

Examples: Prellis Biologics, Miromatrix Medical Inc., United Therapeutics Corporation, Wake Forest Institute for Regenerative Medicine, eGenesis, Inc.

4. Growth of (Bio)Artificial Organs

Mechanical, biomechanical, and bioartificial organs are designed for integration into the human body to replace, duplicate, or augment our natural organs. Each of these three classes of artificial organs has its own material makeup, from inanimate plastics and metals to living cells.3

Examples: KidneyX, Carmat, BiVACOR Inc, Organovo Holdings, Inc., Abiomed, SynCardia Systems, LLC, ReliantHeart Inc., Medtronic

Access & Safety

5. Addressing Inequities & Disparities in Organ Transplantation

Tackling systemic barriers that disproportionately affect certain patient populations, ensuring that everyone who needs a transplant has a fair shot at receiving one as quickly as possible. It is well documented that populations in the United States experience health disparities at specific steps along the pathway to an organ transplant. A clear example can be seen in discussions around the historical use of race-based equations to estimate kidney function. On January 5 of this year, the Board of Directors of OPTN announced it had unanimously approved a process to backdate waiting times for Black kidney transplant candidates who were disadvantaged by the use of the race-based equation.4

Examples: National Kidney Foundation and American Society of Nephrology Joint Task Force and recommended guidelines for race-free GFR. I'd also highlight this book chapter and figure (below) that go into more detail on these issue and current efforts to address them.5

6. Donor Management Systems for Streamlined Organ Matching

Leveraging advanced software solutions to optimize the process of matching organ donors with recipients, enhancing efficiency and success rates. In April, researchers from MIT announced they will partner with UNOS to test and deploy a “continuous distribution” system that aims to make the entire system more efficient and equitable. Continuous distribution is a new allocation framework to match donated organs with registered transplant patients. It is not only a new way of allocating organs in a much more equitable and efficient manner, but it also presents a new way of developing the policies by which we decide who gets the next available organ.67

A January 2023 study by Cleveland Clinic and the U.S. Scientific Registry of Transplant Recipients (SRTR) shows how their new distribution system called the Composite Allocation Score improves transplant allocation equity.8

7. Precision Diagnostics for Ongoing Organ Health

Using state-of-the-art genetic testing to reduce the risk of organ rejection. CareDx offers AlloSure, an early marker of injury and rejection for kidney transplant patients. Natera’s cell-free DNA tests like Prospera and Renasight help patients and care teams get ahead of undetected rejection events that might lead to loss of the transplanted organ.9

Cell-free DNA: A Clear Biomarker for Organ Injury | Credit: CareDx

Examples: CareDx, Inc., Natera, One Lambda, Inc. | A Thermo Fisher Scientific Brand, Omixon, HistoGenetics

8. Robotic-Assisted Surgery and Real-Time Navigation for Enhanced Surgical Outcomes

Employing robotics and real-time navigation tools to increase the precision and safety of transplant surgeries. The first robot-assisted kidney transplant was performed in France in 2001.10 As of 2018, one paper showed 700 donor nephrectomies and 100 kidney transplantations had been performed using the da Vinci robotic surgical system.11 By 2022, Henry Ford Health had performed over 100 robotic kidney transplants, including more than half of all living donor transplants performed by the health system.12

Examples: Intuitive, Medtronic, Stryker, THINK Surgical, Vicarious Surgical Inc., Brainlab

9. Improving Safety and Making More Organs Available Through Ex Vivo Perfusion

Traditionally, donated organs are placed on ice until they are transplanted into a recipient. With ex vivo perfusion, however, a machine keeps organs warm by continuously pumping blood through them. This is also called normothermic perfusion. After early successes in lung transplantation, in recent years we've begun to see these techniques applied in liver transplantation as well, increasing the size of those donor pools.13

Examples: TransMedics, Inc., XVIVO, Paragonix Technologies, Inc., Bridge to Life Ltd.

Beyond the OR

10. Expanding Coverage Policies for Immunosuppressant Drugs

Pushing for broader coverage of immunosuppressant drugs, helping patients afford these essential medications post-transplant. In November 2020, US Congress passed the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act (“Immuno Bill”) indefinitely extending Medicare coverage of immunosuppressive medications for kidney transplant (KT) patients only.14 Last month a new law went into effect that expands Medicare coverage for immunosuppressive drugs beyond three years.15 Unfortunately, patients lose their transplanted organs because they are unable to pay for these meds on their own. It took more than a decade of advocacy work to get this law passed. Sending my sincere thanks and appreciation to the organizations and individuals who have dedicated their lives and efforts to this cause.

Patient Sentiment | Clin Transplant, 2009

Examples: American Society of Transplantation, American Society of Transplant Surgeons, American Association of Kidney Patients, National Kidney Foundation

11. Pioneering Immune Tolerance to Transplanted Organs Through Gene Therapies

Utilizing gene therapies to induce immune tolerance to transplanted organs, which could significantly reduce the risk of organ rejection, and perhaps even our dependency on lifelong immunosuppressant drugs.16

Novel approaches for L-T lung transplant survival | Credit: Frontiers, 2022

Examples: Regenerex, Talaris Therapeutics, ElevateBio, Casebia Therapeutics

12. Ensuring Fair and Efficient Organ Allocation Through Policy Reform

These are the people and organizations advocating for changes in organ allocation policies to ensure a more equitable and efficient system. A 2020 report by Bloom Works and partners reveals a complex, expensive, broken system.17 If you want to understand how the system works, how each of the key players operates within it, and why organ availability is as much about procurement and performance as it is about donation itself, consider reading the report:

"Each year, more than 28,000 viable organs are wasted.”

Despite scientific advancements, the organ donation system is held back by poor management and performance. The U.S. government could save tens of thousands of lives and billions of dollars by holding contractors to more rigorous standards and modernizing the technology within the organ transplant ecosystem."

Part 03: The Technology

I hope you’re feeling a bit more optimistic about the future of organ transplantation after reading Part 2 of this series. While you were reading this, someone joined the waiting list for a new organ. At the same time, clinical and product teams across the globe are working tirelessly to improve access, availability, safety, and continuous care for recipients and donors alike.

Coming up in Part 3, we’ll be taking a closer look at 15 technologies reshaping the transplant care journey as we know it.

Hey, Tim here! The goal of my newsletter and podcast is to make the frontiers of healthcare technology more accessible and actionable for everyone. I write and interview experts about topics like learning, startups, commercialization, care delivery, and beyond. Join 4K+ fellow clinical, commercial, and technical business leaders as we explore a new [space] each month.

Kidney paired donation pilot program to begin matching in October (OPTN, 2010)

Measurement Characteristics of the Knowledge Assessment of Renal Transplantation (KART) (Transplantation, 2020)

Artificial Organs: Innovating to Replace Donors and Dialysis (The Scientist, 2023)

Understanding race & eGFR (OPTN, 2023)

Confronting and Eliminating Inequities in the Organ Transplantation System (NAS, 2022)

MIT AI algorithms aim to revolutionize organ transplant system (HealthcareIT News, 2023)

Information design to support growth, quality, and equity of the US transplant system (AJT, 2022)

New Method of Donor-Lung Distribution Expected to Decrease Deaths Among Those on Transplant Waiting List (Cleveland Clinic, 2023)

AlloSure, by CareDx

Robot-assisted kidney transplantation: an update (CKJ, 2022)

Robot-Assisted Transplant Surgery - Vision or Reality? A Comprehensive Review (Visc Med, 2018)

Robotic-assisted Versus Open Technique for Living Donor Kidney Transplantation: A Comparison Using Propensity Score Matching for Intention to Treat (Transplant Direct, 2022)