Defying the Odds: IVIVA Medical’s novel stride towards bioidentical organs
Harald Ott MD, MBA, Founder and CEO of IVIVA Medical, discussed his biomedical startup’s goal to develop an artificial, bio-identical, implantable organ during Med-Tech World at the Mediterranean Conference Centre.
The odds are not in our favour.
“Your chance of being struck by lightning in a lifetime is 1 in 10,000. The odds of facing chronic disease and single organ failure, though? That’s 1 in 5.”
Dr Harald Ott wasted no time delivering a stark reality at the Technology Showcase, stating, “One out of ten Maltese people grapple with chronic kidney disease.” His message was clear: the impact of this disease isn’t a distant possibility—it’s a present reality, affecting numerous individuals.
Chronic diseases inflict wear and tear on vital organs like the liver, lungs, and kidneys. While remarkable progress has been made in curing once-fatal diseases over the past century, end-stage organ failure remains a challenging prognosis.
This issue is particularly critical for the 1 million patients in the U.S. grappling with kidney failure, where only 25,000 receive the life-saving remedy of a kidney transplant.
“They would’ve endured about 5 years of waiting on hemodialysis—a situation far from comfortable.” To compound the severity, approximately 100,000 individuals succumb each year, roughly 275 patients daily, unable to access life-saving treatments while awaiting a cure that shall never materialise.
When saving lives harms others
Curative treatment, in the form of allotransplantation—transplanting organs or tissues from one individual to another within the same species, becomes increasingly challenging with a limited pool of organ donors.
“The better we get at preventing overdoses and car accidents, the less donor organs will come around to provide a cure to you. There’s the horrible truth of the current situation. It’s what we’re trying to fix.”
As wait lists for transplants lengthen, patients resort to daily medications, managing chronic diseases rather than receiving a definitive cure. Dr Ott’s journey took a profound turn with an inspiring email from Lily, an eight-year-old with chronic kidney disease, expressing gratitude for Ott’s research.
But Lily stands as a rare beacon of hope, an exception in the shadows of those still suffering. Her case poignantly underscores the limitations of transplantation—a viable yet severely restricted solution.
Dr Ott illuminated the promising alternative of living therapeutics, rooted in cellular structures, catalysed by breakthroughs in deriving patient-specific stem cells that evolved into successful therapies.
Transitioning from focusing on individual functions like insulin secretion, Dr Ott posed the pivotal question of replicating entire organs. Here, architecture assumes a critical role, with the advent of additive manufacturing and 3D printing propelling the creation of intricate structures for living therapeutics. Dr Ott envisions personalised living therapeutics, crafted from patients’ own building blocks, as a means to overcome the challenges tied to transplantation.
“Nature’s building blocks are much better than just non-viable devices at fulfilling organic function.”
Utilising these building blocks, kidney organoids are engineered from patient-derived cells, adhering to developmental biology principles to replicate specific kidney functions. The resulting three-dimensional architecture facilitates fluid filtration, toxin removal, and essential electrolyte reabsorption, resembling a biologic dialyzer. These structures showcase significant potential for long-term therapeutic impact.
In a critical step towards clinical translation, Dr Ott demonstrated the feasibility of integrating living building blocks into three-dimensional architecture with a small-scale device transplanted into a large animal.
“This proof of concept reaffirms the promise of integrating living building blocks into three-dimensional architecture for in vivo functionality.”
About the company
IVIVA Medical, a biotech startup stemming from the Massachusetts General Hospital and Harvard Medical Ecosystem, pioneers living therapeutics for kidney failure patients. The company aims to revolutionize regenerative medicine and address the critical shortage of donor organs. In June, the startup clinched the Phase 2 KidneyX Prize, awarded by the Kidney Innovation Accelerator, a collaborative effort between the American Society of Nephrology (ASN) and the US Department of Health and Human Services (HHS), recognizing their advancements in developing a fully implantable bioartificial kidney.
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