Additive manufacturing, otherwise known as three-dimensional (3D) printing, has been around for almost 40 years, but has historically been too expensive to be adopted for widespread use. However, 3D printing has reached an inflection point, as lower costs and technological advancements have made it applicable in countless industries. Today, healthcare, aerospace & defense, and consumer goods industries drive the increasing demand for 3D printing.
Within the healthcare industry, one of the use cases of additive manufacturing is in the form of bioprinting. The most common method of bioprinting works similar to how an inkjet printer works; printers lay down layers of ink (in this case, bio-ink or biocompatible materials, cells and supporting components) to develop 3D functional living tissues. Currently, the main applications of bioprinting are for drug discovery and development, toxicology testing and regenerative medicine.
Organovo, based in San Diego, CA, is a pioneer in bioprinting. The company specializes in bioprinting human liver tissues and kidney tissues to be used for acute and chronic toxicity studies for preclinical drug discovery and development programs. Using a proprietary 3D printing process, Organovo is able to develop multi-cellular, dynamic, and functional 3D human tissue models that remain viable for extended periods of time in vitro and exhibit key functional features that mimic aspects of natural 3D tissue. By being able to test the effects of preclinical drugs on live tissue, drug development can be accelerated as soon as the drug is shown to not be toxic to humans.
|Disruption of cell adhesion||Necrosis||Steatosis|
Figure 1: Analogous to human tissue biopsies, different patterns of damage can be detected histologically in ExVive™ 3D Bioprinted Liver Tissue using various treatments (H&E).
In the short term, Organovo is actively partnering with leading pharmaceutical companies, like Merck, to allow for a more efficient (in terms of both time and money) drug development process. Pharmaceutical development is extremely costly, with average R&D costs per drug of $2.6 billion. Additionally, an overwhelming majority of drugs (94%) end up failing in the clinical trial phase. One of the key focusses of the FDA in drug development is around liver toxicity, which also happens to be the most common cause for discontinuing clinical trials and for withdrawal of approved drugs during the post-market surveillance stage. As such, Organovo’s liver tissue product is a tool that can vastly increase the efficiency of pharmaceutical R&D spend by identifying early on whether a drug will be discontinued due intolerable to liver toxicity.
In the longer term, the company is pursuing its goal of applying its bioprinting technology to more than just preclinical drug development. Organovo sees a future where engineered tissues are used as a routine source of therapy for patients with damaged or diseased tissue. Today, they are working together with partners to do more research on the science that will allow them to make larger replacement tissues on demand, reducing wait times for patients looking for donors and, ultimately, curing diseases and saving lives.
While Organovo’s business is fascinating and will benefit the overall well-being of humanity, it is currently extremely unprofitable. Bioprinting has become more economical, but there is still a long way to go to reduce costs before it can bring this business model to a self-sustainable state. Organovo continuously relies heavily on issuing equity to keep the lights on and fund their operations, having raised almost $200 million in the public markets since the company went public in 2012.
To address the near-term problem of Organovo’s products being unprofitable on a contribution margin basis, the company should work with producers of bio-ink to figure out ways to reduce production costs.
Another way that Organovo is addressing the near-term profitability issue is by joining the Advanced Regenerative Manufacturing Institute (ARMI), which recently received $300 million in public-private investment from leading manufacturers, universities, nonprofits and the federal government to develop scalable manufacturing processes for engineered tissues and organs. The company can work with the other 100 partner organizations in ARMI to make the technology even more accessible.
Organovo and its peers will continue to refine bioprinting technology so that they can create more sophisticated biological structures. There are clear benefits in accelerating drug development and reducing patient wait time for transplants. However, are there any potential risks to look out for? Should this technology be regulated and by what kind of regulatory body?
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