Oct 5, 2016 | By Tess

3D bioprinting company Organovo has just announced that it will be developing 3D printed human liver tissue that can be directly transplanted into patients. If successful, the transplantable liver tissue could be a game changer for the medical field, as it could be the first “robust alternative” to a liver transplant.

In the United States alone, though roughly 17,000 patients are currently on a liver transplant waiting list, only about 6,000 liver transplants are performed each year, meaning that over 10,000 people go without their necessary treatment and must continue waiting indefinitely. Organovo, which has already introduced two 3D bioprinted tissue services (ExVive Human Liver and ExVive Human Kidney), is hoping to develop an at least temporary alternative to straight liver transplants with its transplantable bioprinted human liver tissue.

According to a recent press release, Organovo has decided to pursue the research for the bioprinted human liver tissue after experiencing promising results in its preclinical studies in animal models, which demonstrated engraftment, vascularization, and sustained functionality. Following the successful results, Organovo has announced it will continue its work with a formal preclinical development program.

Keith Murphy, CEO of Organovo, said of the new research: “We’re excited to introduce an implantable bioprinted liver tissue as the first preclinical candidate in our therapeutic tissue portfolio, and see the early results as extremely promising…Advancing our first therapeutic tissue into preclinical development is an important milestone for Organovo, and it speaks to the power of our technology platform in addressing multiple applications, including preclinical safety, disease modeling and tissue replacement products for surgical implantation. We believe that 3D bioprinted tissues have an opportunity to provide options for patients who suffer from liver disorders.”

Organovo is planning to initially gear its bioprinted liver tissue research to two particular areas: acute-on-chronic liver failure (ACLF) and pediatric metabolic liver diseases. ACLF, is a disease which affects over 150,000 people each year in the United States and which causes the deterioration of liver function for those living with liver disease. According to Organovo their transplantable 3D bioprinted liver tissue could be a therapeutic solution to both ACLF and pediatric metabolic liver conditions. On a financial level, the total addressable market opportunity for the two indication areas is over $3 billion.

In terms of time frame, Organovo is confident that if all goes well in its development process, it will be submitting an Investigational New Drug (IND) application for its 3D bioprinted liver tissue to the U.S. FDA within the next three to five years. Additionally, in order to speed up the time to market, the bioprinting company will also explore breakthrough therapy designation and clinical development outside of the United States.

“In our preclinical studies, we deliver a patch of functional tissue directly to the liver, which integrates well, remains on the liver and maintains functionality,” explains Eric Michael David, M.D., J.D., chief strategy officer and executive vice president of preclinical development, Organovo. “We believe our tissues have the potential to extend the lives of patients on liver transplant lists, or those who do not qualify for transplants due to other factors.”

In other words, while the 3D bioprinted liver tissue would not replace an entire liver, it could help to extend the function and health of diseased livers for patients who are on the transplant waiting list. Additionally, the development of the liver tissue is another progressive step to further understanding and developing even larger bioprinted tissues.



Posted in 3D Printer Company



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Jeff wrote at 10/14/2016 7:41:35 PM:

This is huge! Game changing even. Think the equivalent of first developing kidney dialysis except for liver.

Alvaro wrote at 10/7/2016 12:47:22 AM:

Great news! A hope for all of us

Alvaro wrote at 10/7/2016 12:47:21 AM:

Great news! A hope for all of us

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