Surgeon-Led Startup Wins KidneyX Prize for Bioartificial Kidney Development

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IVIVA Medical, a pioneering biotech startup led by Harvard University Professor and Thoracic Surgeon Harald Ott, has won a Phase 2 KidneyX Prize. The Kidney Innovation Accelerator awarded the prize, a collaborative initiative between the American Society of Nephrology (ASN) and the U.S. Department of Health and Human Services (HHS).

Thanks to its groundbreaking work in developing a fully implantable bioartificial kidney made with proprietary 3D printing technology, IVIVA Medical will receive $1 million to continue its research and development of cell-based living therapeutics that replace the kidney’s most crucial functions.

IVIVA Medical has made a monumental stride in the field of organ replacement with its development of human-scale solute-exchange grafts. By using cutting-edge 3D printing technology, IVIVA creates finely separated hollow vascular networks. These networks are then methodically layered to construct a matrix that matches the scale of human organs. According to the company, this intricately designed matrix is populated with diverse types of cells, which then develop into functional tissue. The end product is a sophisticated, human-scale solute-exchange graft that can effectively replicate organ function, paving the way for significant advancements in organ therapeutics.

Renal Care

Often called “silent killers,” kidney diseases are a growing global health issue often linked to underlying conditions like diabetes, hypertension, and obesity. In the U.S., the high cost of treatment, over $100 billion annually, is attributed to expensive procedures like dialysis and kidney transplantation. Medicare spent roughly $81 billion on people with chronic kidney disease (CKD) and an additional $36 billion on end-stage renal disease treatment in 2018 alone.

More importantly, the long wait for a kidney transplant—over 100,000 people are on the U.S. transplant list, but only about 20,000 transplants are performed each year—underscores the urgent need for innovations like IVIVA Medical’s bioartificial kidney. Patients typically spend an average of five years or more on transplant waitlists, with many tragically dying before receiving surgery. Instead, IVIVA Medical aims to revolutionize this scenario by developing fully implantable bioartificial organs, providing a potential cure and a chance at a normal life for patients with organ dysfunction.

“Patients with renal failure experience not only the impact of their disease but also the inevitable side effects of existing treatments because transplant organs are only available for a few lucky recipients,” remarked IVIVA Medical Founder and CEO Harald Ott. “We’re working to transform organ replacement. Because we build these implants from patient-derived cells, there will be no need for long-term immunosuppression, no risk for rejection, and no donor organ shortage.”

As a renowned thoracic surgeon at Massachusetts General Hospital and an Associate Professor in Surgery at Harvard Medical School, Ott has a unique perspective and profound interest in regenerative medicine and stem cell therapy. Having founded IVIVA eight years ago, Ott is dedicated to finding a solution for end-stage renal disease.

Harald Ott, founder and CEO of IVIVA Medical and Associate Professor in Surgery. Image courtesy of IVIVA Medical.

Creating a fully functional bioartificial kidney has been challenging due to the organ’s complexity, which is composed of numerous cell types and responsible for multiple vital functions. However, the KidneyX prize provides IVIVA the resources to advance its technology as the company continues its quest to solve the organ transplant shortage.

“Kidney diseases are common, serious, and deadly. People with kidney diseases have demanded innovative treatment technologies and management strategies to replace dialysis,” commented John R. Sedor, a nephrologist with the Cleveland Clinic and KidneyX Steering Committee Chair. “The Artificial Kidney Prize Phase 2 winners highlight paradigm-shifting solutions in xenotranplantation and regenerative medicine that are being developed to reduce the burdens of kidney disease.”

Echoing these sentiments, U.S. Assistant Secretary for Health Rachel L. Levine added, “HHS is excited and remains committed to the partnership and to advancing kidney care. With the close of the Artificial Kidney Prize Phase 2, I couldn’t be more thrilled to congratulate the winners of the competition. This prize competition leads us to the next steps for advancements and solutions in artificial kidney developments.”

Engineered ten-layer renal scaffold. Image courtesy of IVIVA Medical.

Phase 2 KidneyX Prize serves as a platform to expedite progress within the regenerative medicine, cellular engineering, tissue engineering, systems biology, and synthetic biology communities, targeting advanced research and development stages for an artificial kidney. This phase, spotlighting projects beyond initial proof-of-concept and heading towards larger studies or commercialization, provides a $1 million catalyst for winners like IVIVA Medical. The startup’s victory not only propels innovative work but also represents a beacon of hope for millions worldwide afflicted with kidney diseases, signaling a potential paradigm shift in renal failure treatment.

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