In recent times, drug development timelines in the US have hovered at about seven and a half years. Part of these timelines are the preclinical trials, which are currently run on animals. There is a new way of doing this and it is the stuff of sci-fi moves. Organovo is currently manufacturing living human liver tissue using additive manufacturing (bioprinting in this case). Researchers believe that it could prove to be more cost efficient in assessing the side effects of new drugs on different human tissues before proceeding to human trials. Anywhere from drug development, transplant needs, and all the way to fully replacing animal testing in labs, the ability to manufacture human tissue (and eventually organs) shows enormous potential benefits for society.
Scientists have been, for quite some time now, growing cells and tissue. But recently, they have been able to tap additive manufacturing (bioprinting) for prototyping fully functional human tissue. The objective is to one day be able to create living functional human organs at scale.
Organovo was founded in 2007 and is a for-profit, public (ONVO) biotech company based in San Diego. They are specialized in the developing and commercializing of functional human tissues. The company IPOed in 2012 and raised $46.6M. Organovo is not alone in this developing industry. Companies such as TeVido Biodevices, Cyfuse Biomedical and Regenovo Biotechnologies are competing in this same space today.
In the past, research labs have been able to grow cells using tissue or organ culture. However, these techniques have limitations regarding the placement of cells, complexity of the tissue, desired cell density and architectural design. Bioprinting allows for researchers to build specific designs for what is referred to as scaffolding, where cells are deposited and grown. It also allows for multilayered cell placement and provides the ability to computer-design how different variations of the tissue should look like. This increases the company’s ability to speed up prototyping phases for any given tissue prototype.
For Organovo, this has materialized in their efforts in two completed product lines. Through bioprinting they have been able to develop and scale production of ExVive and 3D lines, with human kidney and liver tissues available. They are placing these products in the market as subjects for pharma preclinical testing on developmental drugs.
Although sales of their products started in 2014 and steadily increased to $4.6M in 2018, Organovo is still losing money. There are two main problems with the current business model that are especially problematic and are affecting its ability to become profitable .
First, it needs to convince the pharma world that testing with bio-printed human tissue is more cost efficient and thus preferable than current processes (i.e. animal testing). However, the FDA still requires extensive animal testing to move on to human trials. In this arena, Organovo has continually been speaking with the FDA to gain credibility of its products as reliable predictors in clinical trials. Until this happens, their value proposition is not materialized, and they cannot scale.
Second, they have yet to develop a fully functional organ to place in the market. They are targeting 2020 for a partial liver transplant using bio-printing technology according to their website. This is, however, contingent on FDA approval.
The company has also been exploring other areas of the rising industry that potentially require less testing such as cosmetics. They have partnered with L’Oreal to use bio-printed skin on their testing phases. This too has a limitation by the FDA that requires animal testing if the company exports to a country that requires it.
Organovo needs to speed up revenue streams to generate profit faster. If the FDA will not allow the pre-clinical testing on bio-printed human tissues, then it might be time for Organovo to start looking for traction elsewhere. Europe, Asia and Latin America might be interested in trying out this novel approach.
Important questions to consider in the future regarding bioprinting of human tissue are many. However, the space of ethics jumps right out, since the companies that will be dealing with this will have to respond not only to the pressures of profit as we saw above from investors, but also to the pressures of stakeholders and society at large. Will the development of this technology provide a significantly prolonged life for those who can afford it? And if so, will the rest of the population be condemned to living significantly shorter lives? Who will own the rights to an organ produced by such companies? Will new organs, different from what we see in nature be developed?
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