NSF Engine Spotlight: Building the Regenerative Medicine Supply Chain in North Carolina
“With regenerative medicine, we will now for the first time be able to help people with diseases that were not addressable with small molecules or other available technologies.”
Tim Bertram, PhDCEO of the Regenerative Medicine Engine
Dialysis is one of the most expensive treatments in the American healthcare system. It’s also profoundly disruptive: three times a week, patients must travel to and from their clinic and sit in a chair for four hours while a machine takes on the job of their kidneys and filters their blood through a needle in their arm — a process that leaves patients feeling drained and exhausted. Their entire life must be planned around these dialysis sessions, just to stay alive.
Kidney disease is just one of many chronic diseases that burdens the healthcare system and debilitates the quality of life for millions of people. But what if you could restore kidney function and keep people off dialysis? What if you could fix the faulty organs that drive chronic disease?
This is the promise of regenerative medicine. Rather than managing the symptoms, regenerative medicine addresses the roots of chronic disease: correcting genetic errors, replacing impaired organs and tissues, and restoring lost function. And because it uses the patient’s own cells, it doesn’t have the risk of immune system rejection that conventional transplants do.
Regenerative medicine could be transformative for the healthcare system and the lives of millions of patients. The applications are not limited to kidney disease: it could be a game-changer for heart disease, Parkinson's, diabetes, and a wide range of other chronic diseases. You could restore function for wounded soldiers returning home from combat. People who have spent decades in a wheelchair could regain the ability to walk.
“With regenerative medicine, we will now for the first time be able to help people with diseases that were not addressable with small molecules or other available technologies,” said Tim Bertram, PhD, CEO of the Regenerative Medicine Engine in North Carolina (RegenMed Engine). The technology is still in relative infancy, but the RegenMed Engine has quickly become one of America’s leading hubs for commercializing regenerative medicine and bringing new therapies to the market.
Members of the Regenerative Medicine Engine leadership team listen to a presentation in September 2024.
Photo courtesy of the Regenerative Medicine Engine. Used with permission.
The Challenges of Scaling Regenerative Medicine
Despite the promise, the reality today is that regenerative medicine treatments rarely reach the patients who need them most. Like any medicine, there are many cases where the treatment doesn’t make it past clinical trials. But in many other cases, regenerative medicine startups aren’t failing due to the science, but rather due to challenges scaling the business.
As RegenMed Engine COO Jesse Thornburg, PhD, put it in a recent podcast, “if we were manufacturing cars, you could have a manufacturing facility and you could order the bolts, you could order the engines, you could order the tires, you could order the things you need to assemble your car. Regenerative medicine is so new that you can’t order the tires.”
To fix this, the RegenMed Engine is building the infrastructure to enable regenerative medicine startups to manufacture their treatments at commercial scale. Without an industrialized, repeatable process to keep costs down, growing cells and tissues for regenerative medicine would remain prohibitively expensive. To create a functioning ecosystem, every component of the supply chain needs to be nurtured.
This includes not only the treatments themselves, but also better ways to grow cells and test treatments — so they don’t fail when they reach clinical trials. For example, Pepgel, one company in the ecosystem, provides the foundational biomaterial infrastructure that other companies in the regenerative medicine space use to culture cells, grow tissues, and develop therapeutic products. Their hyrdogel technology allows cells and tissues to be cultured in 3D, rather than the 2D space of the petri dish.
Susan Sun (right) oversees lab technicians using the product from her company, PepGel. Sun moved her company to Winston-Salem from Kansas to be part of the Regenerative Medicine Engine's ecosystem in 2024.
Photo courtesy of the Regenerative Medicine Engine. Used with permission.
Another company, Biorg, is creating miniaturized biological structures that simulate human organs, called organoids, to more accurately test new drugs. In the future, these organoids could be made from the cells of individual patients, determining in the lab which drugs would work best for their unique body.
As Dr. Thornburg sees it, this supply chain is critical for national security: “By accelerating the regenerative medicine supply chain in the United States today, we won’t have to import it 30 years from now.”
Regenerative medicine is the definition of Tough Tech — new technology with the potential for a transformative impact on society, but with high barriers to success. At The Engine, we’ve seen first hand how important it is to have a nurturing ecosystem that can help Tough Tech breakthroughs survive the transition from the lab to the market. But as the RegenMed Engine proves, not every ecosystem will look like The Engine’s ecosystem in Boston.
Building a One-of-a-Kind Regenerative Medicine Ecosystem in North Carolina
Before the RegenMed Engine, North Carolina did not have a substantial biotech ecosystem — capital providers, a network of mentors, a culture of entrepreneurship — to nurture early-stage companies in the way that The Engine has in Boston. Without a supporting ecosystem, biotech startups can quickly burn through capital, especially if they had to buy their own lab space and equipment.
The team that would become the RegenMed Engine found that it would be safer to de-risk technology in the shelter of academia. Over 20 years, they built a research translation pipeline at the Wake Forest Institute for Regenerative Medicine (WFIRM), where R&D moved through GMP and the first two phases of clinical trials before it ever left the university. The shared lab access reduced the upfront costs of R&D, and increased the exit value when the research eventually spun out as startups.
In 2024, the success of the program caught the attention of the National Science Foundation (NSF), who funded it as one of nine inaugural Regional Innovation Engines. The RegenMed Engine was born. To support these ecosystems, the NSF also invested in the development and launch of The Builder Platform, powered by The Engine to share the lessons we have learned from creating a successful regional innovation ecosystem in Boston and build a peer-learning community.
WFIRM research associates, students, lab technicians and employees of local startups work in the Test Bed, a signature program of the Regenerative Medicine Engine. The Test Bed houses some of the latest regenerative medicine equipment, donated by their companies, and is available for use for free by people in the Regenerative Medicine Engine's ecosystem.
Photo courtesy of Wake Forest Institute for Regenerative Medicine. Used with permission.
Indeed, through The Builder Platform, The Engine would not only share its own insights with Engines like the RegenMed Engine, but also learn from them and share these lessons across other regional ecosystems. After all, as the RegenMed Engine proves, there’s no one-size-fits-all model for building a regional innovation ecosystem — every region will have its own unique set of resources and challenges, and they can all learn from each other.
In the RegenMed Engine’s case, they had built a strong foundation for nurturing the initial R&D of promising innovations. But they were still developing the mentorship and programming infrastructure that would help PhDs make the transition to become successful CEOs.
“A lot of people say we need more scientists, we need more innovation creating these new things,” said Dr. Thornburg. “But from my perspective from being in this position now, I can say what we need is more CEOs that are willing to put in 18 hour days, every day of the week, for 20 years to make it happen.”
A Bootcamp for Regenerative Medicine CEOs
The challenge of nurturing startup leadership is not unique to North Carolina. Since our founding, The Engine has learned how important it is to prepare researchers for the hard realities of leading an early-stage company.
We’ve since launched translation programs including Blueprint by The Engine™ and Whiteboard by The Engine™, respectively aimed at graduate students and research faculty. These programs provide a crash course on the essential skills needed to found a scalable, impactful Tough Tech startup: from hiring and fundraising to leadership and public affairs. Now, The Builder Platform is sharing what we’ve learned through these programs to help Regional Innovation Engines like the RegenMed Engine build their own founder programming.
In April 2025, these efforts culminated in The Founders’ Journey, a free two-day event designed to bridge the gap between research and commercialization. The event exceeded expectations, with 40 founders, researchers, students and faculty members in attendance. Attendees gained tools and strategies to build their own regenerative medicine startups, and connected directly with veteran startup executives for firsthand insights on the entrepreneurial journey.
Steve Bauer, a regulatory expert with the Regenerative Medicine Engine, gives a presentation on the regulatory landscape during the RegenMed Engine's Founder's Journey event in April 2025. The event provided an overview of the challenges and opportunities of starting a regenerative medicine company and how the RegenMed Engine can help.
Photo courtesy of the Regenerative Medicine Engine. Used with permission.
Tech translation programs like The Founder’s Journey prepare early-stage founders for the critical process of raising capital from investors. To support their fundraising, the RegenMed Engine is building a new investor network for regenerative medicine, inspired by The Engine’s investor network. With its narrow focus on regenerative medicine, the RegenMed Engine is able to attract investors that understand the field, curating a menu of startups across the value chain for them to invest in.
The Vision for Regenerative Medicine
By providing the support for early-stage regenerative medicine companies, the RegenMed Engine hopes to improve quality of life and bring hope to millions of patients. Take Plakous Therapeutics for example, a company in the ecosystem using an extract from donated full-term placental tissue to restore and repair organs damaged by inflammatory diseases. Another company, FetTech, harnesses signaling components and biomolecules found in naturally-derived tissue, enhancing the body’s own regenerative capabilities to heal chronic wounds and damaged organs.
The economic impact could be just as profound as the health impact. With the right support in place, more researchers will be empowered to start new businesses, create jobs, and retrain people from other industries. People debilitated by chronic disease — not to mention their caregivers — will be able to return to work. Healthcare costs would come down by curing patients instead of treating them for the rest of their lives. And as the ecosystem scales, the costs associated with each regenerative treatment will come down even further.
The RegenMed Engine shows what’s possible when an ecosystem provides startups with the resources they need to scale. Not every ecosystem will look the same, but with the right support, solutions to society’s greatest challenges can thrive anywhere.
