Bioverge, Inc.

Apr 19, 2021

4 min read

Reimagining Artificial Organs: IVIVA Medical

Photo by ThisisEngineering RAEng on Unsplash

Over the past century, many diseases that previously would have been fatal are now almost entirely curable. However, the prognosis and treatments for end-stage organ failure are still bleak.

Chronic diseases lead to wear and tear in organs such as the liver, lungs, kidneys, and more. Eventually, the damage builds up to a point where the organs stop working — at this point, patients currently have relatively few options. The current standard of care for patients with end-stage organ failure is an organ transplant. However, the demand for a transplant greatly exceeds the supply of organs.

When you check off “organ donor” on your driver’s license, you are opting in to have your organs donated in the event of your death. What is often overlooked is that 99.7% of registered donors will be ineligible for actually donating their organs, causing a backlog of over 100,000 patients on the organ waitlist.

Out of the organs needed, the ones in the highest demand are kidneys. Chronic kidney disease affects 15% of all Americans, with over 700,000 patients progressing to end-stage renal disease, where the only treatment options are a kidney transplant or dialysis several times a week. Older adults with ESRD are a rapidly growing group and they have a mortality rate that is twice that of older adults with cancer. The US currently spends $35 billion each year caring for ESRD patients.

Currently, the only two treatments for end-stage kidney disease: dialysis at least 3 times a week or a kidney transplant. At age 60, a healthy individual is expected to live 20 more years, while an individual on hemodialysis has a life expectancy of only 4 more years. If the patient is able to receive a transplant, however, the 5-year survival rate jumps from under 50% on dialysis to around 80%.

Now, imagine finding out that you or a family member has been diagnosed with kidney failure. However, instead of having to go into a dialysis center every other day or waiting in the organ donation line for years, you’re able to opt for a biologic device that is implanted and consistently operates in the background, much like a real kidney.

This is what the biomedical startup IVIVA is aiming to do: create an artificial implantable organ that allows the patient to bypass the traditional treatment avenues. The technology will have the potential to impact hundreds of thousands of lives across the country.

For the past 50 years, no significant strides have been made in treatment options for ESRD patients, however, IVIVA’s current work in this area is groundbreaking. The team’s goal is to create a fully biologic implantable technology that does not require dialysate, mechanical pumps, or be subject to fibrosis and fouling typical of devices based on synthetic materials. By doing this, they essentially create an artificial model of a kidney, removing the need for constant dialysis or a kidney transplant. This has the potential to significantly improve the quality of life in the patients and improve disease prognosis.

The team has already successfully tested their kidney prototype on a porcine animal model and plans to start pre-clinical trials in two years for both their kidney and pancreas models.

IVIVA has a highly experienced team of academic and industry leaders. The startup was founded by Dr. Brock Reeve, the director of Harvard’s Stem Cell Institute, and Dr. Harald Ott, a surgeon at Massachusetts General Hospital and an associate professor of surgery at Harvard Medical School. Dr. Harald Ott has spent much of his academic career working on organ engineering with patients before and after organ transplants. Throughout his years working in the field, he was able to see firsthand the devastating impacts of ESRD and the difficulties that patients going through dialysis almost every day have to face. He was inspired after working with a pediatric ESRD patient to create a better solution and founded IVIVA.

With scientific advisors including the Director of Organ Manufacturing at United Therapeutics, the United Network for Organ Sharing CMO (UNOS manages the national organ donation network), the Chief of Transplantation at Massachusetts General Hospital, the chair of regenerative medicine at the University of Southern California, and a senior Harvard bioengineering professor, the team is well-positioned to become a leader in this field.

IVIVA previously raised over $3 million in funding from reputable groups such as AstraZeneca, Johnson & Johnson, the Department of Defence, United Therapeutics, and more. Bioverge had the privilege of participating in their most recent round alongside notable investors including Bold Capital and Prime Movers Lab, among others.