Bioprinting- “the liveliest—literally—field of 3D printing may sound like something from a sci-fi movie, but (spoilers) it’s real and happening now” . While technology is still in its early days of the ability to print entire organs, significant advances have been made in the ability to bioprint tissues and vascular structures (blood vessels).
In fact, Organovo invented the world’s first commercially available bioprinter Novogen MMX in 2009 which gained traction with academic and research labs (see Figure 1) . In big pharma drug development, bioprinting has remained a more distant reality up until the last few years. Organovo is changing this and has started to set up partnerships on development of bioprinted tissue with at least 6-10 major pharma companies, and most publicly with Merck in 2015, creating the opportunity to accelerate drug development cycles [3, 4].
What exactly is the Organovo technology
Organovo offers customers (pharma companies and academic research facilities) “structurally and functionally accurate bioprinted human tissue models”, specializing in the liver . Much like traditional 3D printing, the NovoGen Bioprinter® Platform (MMX-07) does “inkjet bio-printing” – using “bioink” to print living cells layer-by-layer . Besides manufacturing the printer, Organovo sources normal or diseased human cells from its subsidiary Samsara and produces its own NovoGel® Bio-Ink to use as inputs into the printer platform. The bioprinted tissue output is used in predictive preclinical testing of drug compounds that is either performed by Organovo itself or the customer. See Figure 2.
Why do we care?
- More and better quality of drugs (with efficient toxicity studies) – Merck and Organovo hit their first key development milestone of their research partnership in April 2018, publishing scientific evidence that shows 3D printed tissue is better than 2D alternatives used in traditional pre-clinical testing . Higher quality of testing using readily available bioprinted tissue means improved drugs and more drugs passing through the development process.
- Shorter drug development cycle – Liver toxicity is the #1 reason pharma companies discard drug trials. Efficient toxicity studies using Organovo’s bioprinted tissue means disease evolution can be assessed in a more true-to-life way, and a go/no-go decision can be made sooner in the drug development process . Further, by collaborating with pharma companies directly on research, the lag time of relevant research reaching industry-insiders is shortened.
Opportunities on the horizon
In the short term, Organovo has already joined the Advanced Regenerative Manufacturing Institute (ARMI) ecosystem which has 100 partners. ARMI has over $300M in funding and provides the opportunity to collaborate with others to engineer scalable manufacturing for bioprinted tissues .
In the long term, Organovo is approaching the FDA in early 2020 with an investigative new drug (IND) application wherein its bioprinted liver tissue can be used for the treatment of rare diseases . CEO Keith Murphy and senior management has committed progress to the street in multiple earnings calls towards filing an IND in 2020 for orphan designation .
Longer term challenges and recommendations
- Profitability: Organovo is one of the only publicly listed companies in the bioprinting industry and withstands constant scrutiny from the market. It has been unprofitable in the last few years, with falling share prices and will run into further cash flow problems if it needs to accelerate R&D to meet its 2020 targets. My (arguably) radical recommendation would be to consider taking the company private for a few years and raising cheaper capital from investors looking for long term returns.
- Technical hurdles: Significant technical challenges still exist with bioprinting around sensitivities of living cells and the construction of tissues. My recommendation would be to embrace open innovation (in the ARMI ecosystem or otherwise) and offer multiple academic institutions the opportunity to rapidly test Novogen bioprinting platform compatibility with more kinds of bioinks, biomaterials and thus more use cases simultaneously.
- Competition: Several other startups are vying to achieve scalability in the space [2, 11]. My recommendation would be to learn from their competitors’ business models. For example, Advanced Life Solutions’s approach is to provide an end-to end solution. It sells its BioAssembly bot (6-arm robotic printer) printer directly to customer but makes profit from its bio-inks and pre-processing software technology that allows researchers to own the modeling of the human tissue .
Questions remaining in the Petri Dish
- Approximately 1500 patients on the waitlist for liver transplants died in 2016 before they could receive an organ . How can Organovo build on competitor offerings in the bioprinting industry to save lives by printing new livers on demand?
- What are the ethical concerns as Organovo aggressively approaches the FDA for the IND (Investigational New Drug) orphan drug status? Should bio-printed tissue / organs be regulated as biological products or drugs/devices?
 Sirinterlikci, Arif, and Lauren Walk. 2014. “Bioprinting: Science or Fiction?“, SME 2014 Medical Manufacturing Yearbook of Manufacturing Engineering
 Dababneh, Amer B., and Ibrahim T. Ozbolat. 2014. “Bioprinting Technology: A Current State-Of-The-Art Review”. Journal Of Manufacturing Science And Engineering 136 (6): 061016. doi:10.1115/1.4028512.
 Organovo. April 22, 2015 Form 8-K,<https://www.sec.gov/Archives/edgar/data/1497253/000156459015002746/onvo-8k_20150421.htm>, accessed November 2018.
 Speights, Keith. 2018. “5 Things Organovo Holdings, Inc. Management Wants You To Know — The Motley Fool”. The Motley Fool. https://www.fool.com/investing/2016/06/13/5-things-organovo-holdings-inc-management-wants-yo.aspx.
 Organovo website
 Madden, Lauran R., Nguyen, Theresa V. et. al. “Bioprinted 3D Primary Human Intestinal Tissues Model Aspects of Native Physiology and ADME/Tox Functions”. iScience. Volume 2, 2018, Pages 156-167, ISSN 2589-0042, https://doi.org/10.1016/j.isci.2018.03.015.
 “Better Tests For Liver Toxicity Would Mean More Medicines — And Safer Medicines — For Patients – American Chemical Society”. 2018. American Chemical Society. https://www.acs.org/content/acs/en/pressroom/newsreleases/2013/september/better-tests-for-liver-toxicity-would-mean-more-medicines-and-safer-medicines-for-patients.html.
 Organovo. Organovo and Samsara Sciences Partner with New Manufacturing USA Institute. [online] GlobeNewswire News Room. Available at: https://globenewswire.com/news-release/2018/05/03/1495905/0/en/Organovo-and-Samsara-Sciences-Partner-with-New-Manufacturing-USA-Institute.html [Accessed 13 Nov. 2018].
 Organovo. Investor Presentation March 2018. Available at Capital IQ.
 Organovo Holdings, Inc. NasdaqGM:ONVO. FQ2 2019 Earnings Call Transcripts. Thursday, November 08, 2018 10:00 PM GMT . Available at Capital IQ.
 The Economist. “A Tissue of Truths – Printed human body parts could soon be available for transplant” Jan 28th 2017.
 Peels, Joris. 3Dprint.com “Interview with Jay Hoying and Michael Golway of Bioprinting Company Advanced Solutions Life Sciences” November 7, 2018. [Accessed 13 Nov. 2018]
 Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). OPTN/SRTR 2016 Annual Data Report. Rockville, MD: Department of Health and Human Services, Health Resources and Services Administration; 2017 http://srtr.transplant.hrsa.gov/annual_reports/Default.aspx Accessed 12th November 2018