This article may contain forward-looking statements as defined by federal and state securities laws. Forward-looking statements include statements concerning plans, objectives, goals, strategies, expectations, intentions, projections, developments, future events, performance or products, underlying assumptions and other statements which are other than statements of historical facts. Forward-looking statements are only predictions that relate to future events, or our future performance, and are subject to known and unknown risks, uncertainties, assumptions, and other factors, many of which are beyond our control. As a result, we cannot guarantee future results or performance as that performance is not necessarily indicative of future results.
____________
Organovo Holdings, Inc. develops three-dimensional (3D) bioprinting technology for creating functional human tissues on demand for research and medical applications. The company’s 3D NovoGen bioprinting technology works across various tissue and cell types, and allows for the placement of cells in desired pattern. It offers NovoGen MMX Bioprinter, a commercial hardware and software bioprinter platform to create tissues for bioprinting research and development. Organovo was founded in 2007 and is based in San Diego, California. The company's web site is at Organovo.com.
Engineering.com: Thank you Mr. Murphy for spending time with readers of Engineering.com.
You co-founded and have been the CEO of Organovo since August, 2007. What are the most significant breakthroughs in 3D bioprinting that have been made over those 6 years?
Keith Murphy: There are many things we can’t disclose today, but of those we have disclosed:
-Demonstrated printing of first fully cellular engineered human artery
-Demonstrated use of stem cells from fat tissue to create arteries
-First implantation of bioprinted tissues into in vivo (animal) studies
-Demonstrated 40 days of performance of 3D Liver tissue – with biological activity comparable to human liver!
Engineering.com: Organovo currently supplies Novotissues™, 3D bioprinted tissues which render more natural cell to cell interactions for medical research and drug studies. Can you list some of your past and current customers for these tissues, and are you in discussions with any potential new customers at the moment?
Keith Murphy: Our first product launch is slated for 2014, for a 3D Liver product to be used in toxicology by pharma customers. We have disclosed a number of partnerships, but that will be the first time we have customers in the traditional sense.
Engineering.com: Data from The US Dept. of Health and Human Services reveals there are nearly 100,000 patients with chronic renal failure needing a kidney transplant and yet less than 17,000 transplants were performed from January-July 2013. When do you believe we will see fully functioning organs such as kidneys, the liver, pancreas, etc. that can be transplanted, and which fully functioning organ is Organovo now closest to bioprinting?
Keith Murphy: Organovo is focused on two things currently: the bioprinting of functional tissues from large organs at a very small size, to be useful in drug discovery and development research, and the development of simple tissues that can be used in direct surgical therapy. We are years away from use of these simple bioprinted tissues in clinical trials, but we are in pre-clinical studies today. The types of tissues to contemplate here are heart muscle patches, nerve grafts, blood vessels for bypass. These smaller tissues are technically achievable with today’s technology and can have a significant positive impact on patient health.
Engineering.com: Do we know yet if bioprinted organs will carry a reduced risk of rejection by patients, and if recipients of bioprinted organs will be required to take anti-rejection medications as they now do?
Keith Murphy: We have conducted research studies such as an SBIR from the NIH in which, using only fat tissue taken from an individual patient, we produced a bioprinted artery with three cell types. These structures have not yet been given to patients clinically, but should it be demonstrated longer term that such tissues have benefit, these patients would not have to take any immune suppressant drugs, given that the cells used came from their own bodies.
Engineering.com: Can you discuss the ramifications of patents U.S. 8,143,055, UK GB2478801, and GB2489081 on vascular tubes for Organovo and its shareholders, specifically on the moat these and other patents around the globe create for the company?
Keith Murphy: Generally speaking we have been successful in developing tissues that are fully cellular – and the creation of a fully cellular tissue such as the bioprinted artery described in these patents has two key features: one, cells are able to behave like they do in the body, and the tissues are novel compared to previous tissue engineering IP. Importantly, composition of matter patent claims that issue on such tissues mean that, although we also have bioprinting method IP, our use of bioprinting to create something entirely new allows us to create a patent that protects against any future method being used to duplicate our work.
Engineering.com: Looking at the most recent quarterly results for the 3 months ending June 30 2013, Orvanovo reported revenue of $94,000 USD from collaborative research projects, down from $259,000 for the same quarter of 2012. What steps is the company taking to improve revenue growth going forward?
Keith Murphy: Our revenues are always going to be lumpy because they are substantially contributed to by partner revenues. Companies similarly reliant on partnerships, such as Medarex and Abgenix historically, had seen revenues move around quite a bit, as it’s hard to reproduce a multimillion dollar milestone payment quarter over quarter. We hope that investors will look at our long term picture and judge our progress over a slightly longer time horizon.
Engineering.com: What upcoming investor, business, and/or medical conferences will Organovo be attending?
Keith Murphy: World Stem Cell Summit, Dec 2014, San Diego; Healthcare conferences for Investment banks, which should be announced via press releases; and we try to update our retailinvestorconferences.com presentation on a regular basis. The most recent version there now is from September 12.
Engineering.com: Last question- what excites you the most about Organovo Holdings and the future of the company?
Keith Murphy: We have a tremendous team working on this technology, and watching our growing team advance the platform and leverage it to do amazing new things is very exciting. We rely heavily on very smart, very dedicated people working on the individual projects to allow the potential of this technology to translate to results. Seeing them succeed, making powerful individual contributions, and knowing that this will continue and will only grow over time, is electric for our entire leadership team.
____________
About Keith Murphy: Mr. Murphy has 20 years of experience in biotechnology, including serving in Product Strategy and Director of Process Development roles at Amgen. He is a co-founder of Organovo and has been responsible for all company operations since 2007. His ten years at Amgen included four years as Global Operations Leader for the largest development program in Amgen’s history, Phase 3 osteoporosis/bone cancer drug denosumab. At Amgen, he also worked to develop several other novel formulation and device products. Prior to Amgen, he played a central role at Alkermes, Inc. on the development team for their first approved product, Nutropin (hGH) Depot. He holds a B.S. in chemical engineering from the Massachusetts Institute of Technology and is an alumnus of the UCLA Anderson School of Management. Mr. Murphy serves as Vice Chairman of the Alliance for Regenerative Medicine, comprised of over 120 member companies, patient advocacy foundations, venture capital firms, and academic research institutes focused on the advancement of regenerative medicine through engagement with government leaders and cooperative efforts.