The notion of 3D printing human organs has been around for a while now. Just last year, after seeing one of my previous articles on additive manufacturing (AM), one of my astute readers asked me when organ printing might become a reality. I had to reply that I didn’t know.
I still don’t, but I have a better answer now: probably in the next several years, thanks in part to the progress made by 3D Systems in its collaboration with United Therapeutics Corporation (UT) and Lung Biotechnology PBC, their organ manufacturing subsidiary. 3D Systems announced a few weeks ago that they’re significantly expanding their investments and efforts in regenerative medicine based on new breakthroughs in bioprinting for lung replacement.
3D Systems has been on a tear in the new calendar year, with its stock rising by over 300% after its estimated 4th quarter revenue of $170 to $176 million beat analysts’ $140 million estimate, and on the heels of its announcement in early January of the sale of two software businesses. Now that announcement late last month has added to those tailwinds. UT, meanwhile, has seen its stock price rise as well, though less meteorically. It had already been rising fairly steadily and substantially through last year despite headwinds from Covid-19 causing mixed business results (earnings were down a few percentage points, but adjusted EPS were up slightly). UT’s share price rose about 75% (though admittedly from something of a trough) through all of 2020, and is now up another 6% this year.
One key driver for the decision by 3D Systems to expand their work in non-solid organ and tissue generation is the tremendous progress they’ve made in printing solid-organ scaffolds for lungs. It represents a big breakthrough in work that’s been underway for some time. “We started the program a few years ago with UT,” said Chuck Hull, who invented stereolithography, founded 3D Systems, and now serves as their CTO. “Their CEO, Martine Rothblatt, is a true visionary who was one of the founders of Sirius XM, then founded UT and asked, ‘Can we produce transplantable lungs?’ She looked at that a variety of ways, and proposed a solution to me: ‘Can you build scaffolds that we can perfuse with lung cells and grow complete lungs?’ At the time I said no, we can’t.”
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But it didn’t end there. “I thought about her question for a year, and went back to Martine and said I think we can do it,” Hull continued. “We put a team together between the two companies. There was a lot to work out. We decided to print the scaffolds with hydrogels, because the body is mostly water—but that meant printing a material that’s gooey and soft. We’re used to printing in hard plastics. Once we got that figured out, then we knew the cells needed someplace to grow. That meant printing in fine detail to allow spaces for cells to live in. But printing smaller, with high resolution, slows things down, so then we needed higher print speeds. Those things have taken the last three years to figure out, and there’s still clinical trials and regulatory work to be done—but on the technology side of the scaffolds themselves, I’d say we could implement that now.”
The success in printing that unique structure is a milestone in a number of ways. “Imagine a very fine, highly detailed sponge-like structure with wall thicknesses a fraction of the diameter of a human hair, but yet strong enough to support cell growth and blood flow needed to sustain life,” said Dr. Jeffrey Graves, President and CEO of 3D Systems. “It allows for the creation of organs using actual human cells, which will reduce the chance the body rejects the transplant. The structure is designed and created to allow vascularization, so there’s plenty of blood flowing to the tissues. That’s what we’ve achieved with UT. What Chuck and the team have accomplished is nothing short of amazing. The potential for positively impacting humanity is remarkable. Outside of solid organs, think about replacement tissue for trauma patients, or tissue to allow for better breast reconstruction for cancer survivors. Having reached this state of the technology, there’s now a whole range of human applications, and we’re looking at developing other partnerships around those, while we continue our work with United Therapeutics on lungs and potentially other solid organs.”
Beyond the direct human applications, Graves sees research possibilities as well. “Another potential application is referred to as ‘tissue on a chip,’” he said. “That would produce better testing devices for drugs and other therapeutic purposes, such as cancer treatments. This could help accelerate that kind of development, and could reduce the need for animal testing as well.”
It’s interesting to contemplate that, as an inventor of one of the original 3D printing technologies, Hull helped launch an entire industry a few decades ago. Now his leadership of this bioprinting collaboration is not only accelerating the medical side of the 3D Systems business, but more importantly is also forging a new industrial path for revolutionary healthcare applications of AM.
“I think the takeaway is that we’re well on our way to having implantable tissues,” said Hull. “But that doesn’t happen fast. Long-term, I definitely see a business around this. Short-term, we see steadily increasing revenues.”
“While the technology itself is amazing in its potential benefits to humanity, the business model for 3D Systems is also exciting, and one that is not new to the company,” Graves said. “For years we have developed and produced advanced medical products for the human body using additive manufacturing in a highly disciplined, process-controlled and FDA-regulated environment. With this foundation, if you look at the progress we have now made in all of the essential hardware, software and materials elements of bioprinting, we have the opportunity as a company to address a variety of applications within the human body. That’s why we’re increasing our funding and investment and expanding our partnerships to make these applications a reality. When you see this tremendous scaffold printed, and then you see blood flowing through it that could sustain human life, it’s remarkable, even for someone from an R&D background like me. I am continually amazed at the potential this technology now offers.”
Graves sees the organs and tissues work as a natural extension of what’s already a strong business for 3D Systems. “In terms of the impact on our company, our healthcare business is growing nicely, now approaching half of the company revenue,” he said. “We believe that regenerative medicine will add to this growth, becoming a significant business in its own right in several years. This technology offers tremendous benefits for human life, whether helping people whose lungs or kidneys are failing, or offering remedies for someone who’s experienced facial or other traumas in their body. It’s sad when you think of the tremendous shortage of replacement organs today and that the primary supply originates from the loss of another person’s life. The only way to address these needs is through an alternative source of supply, and hopefully one that offers greater compatibility with the recipient of the new organ or tissue implant. With the progress we are now making, we believe that regenerative medicine, and the underlying bioprinting technology we have now demonstrated, can ultimately be an answer to this problem.”
All that being said, though, I still don’t have the specific answer for the question from the reader of last year’s article I mentioned above. But I do have this:
“I’m guessing some of your readers will be saying, ‘I have such-and-such condition—how soon will this solve it?’ Hull said. “And my answer is, as quick as we can.”