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Commercialization of bioprinting technology
This brings on another issue of data protection commercial success is likely to be at least 15 – 20
on a global scale which requires specialized years away, when bioprinted human organs will
infrastructure for storing encrypted files with become available for transplantation at the costs
data about cells, tissues, and organs received by comparable to the current market. However, a few
patients. This information should also be in a companies have already launched products into
unified format, accessible by commercially used the market and have raised investments through
bioprinters, with measures to protect intellectual various available means.
property also in place. Clearer guidance would There is an important distinction between
also assist innovators, who had to be able to better investments in bioprinting companies focused
understand how their products are to be classified on regenerative medicine and companies that are
once released into the market. One suggested working toward creating a cultured meat product.
approach to licensing in bioprinting is placing While the former has produced a couple of
responsibility on companies to share benefits and notable initial public offering (IPOs) (Organovo,
at the same time emphasizing the role of public Cellink), the latter have also recently begun to
research. attract investor interest, which led to some major
A draft version of guidelines was released in investment rounds. In this chapter, we are covering
May 2016 by the US Food and Drug Administration regenerative medicine companies, and you can
(FDA) for manufacturers of medical devices that read about cultured meat investments in chapter 9.
work with additive manufacturing . While it The first bioprinting company that raised
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was meant to provide manufacturers with the significant amounts of capital is Organovo
agency’s initial outlook on manufacturing 3D which had set to create tissue models for drug
printed devices, it does not address the use or discovery. Organovo went public in 2012 using
incorporation of biological, cellular, or tissue- a reverse IPO and over the next few years raised
[72]
based products in additive manufacturing. about US$ 128 million in several installments .
Products that contain living human cells/tissues This was a crucial breakthrough for the whole
(including specific medical devices) and are bioprinting industry not to mention the company
intended for transplantation in human patients are itself. In December 2019, Organovo and Tarveda
qualified by the FDA as human cells, tissues, and Therapeutics announced a merger agreement
cellular and tissue-based products (or combination under which Tarveda would execute a merger
products). Similar classification criteria exist in with a subsidiary of Organovo; the joint company
the EU, but without a general definition or specific would use the name Tarveda Therapeutics, Inc.
regulation for combination products. They are and trade on Nasdaq.
currently regulated as medicinal products or CELLINK decided to pursue their IPO just
medical devices [70,71] . several months after the company was created.
In summary, international cooperation is However, that was not without reason, as at the
required to create clear legal guidelines regulating time, their bioprinter (priced at US$ 10,000) was
3D bioprinting while ensuring that intellectual sold in 25 countries, mostly to research institutions.
property, safety, and bioethics are addressed on a CELLINK listed on Nasdaq First North, and notably
their IPO was oversubscribed by 1070%. Cellink’s
global scale. Hopefully, together with educating current market cap is at US$ 400 million .
[73]
medical professionals and general population, this Cyfuse Biomedical K.K., a manufacturer of 3D
will enable future innovations and active medical bioprinters from Japan, closed its Series B private
applications of 3D bioprinting. placement funding in 2015. Cyfuse raised about

5 Financing US$ 12.5 million, bringing the total amount of
investments to about US$ 17.8 million .
[74]
3D bioprinting industry is not currently Poietis, a bioprinting company that was one
being widely used in healthcare, and its large of the first to create a commercially available

70 International Journal of Bioprinting (2020)–Volume 6, Issue 3