"Caralynn Nowinski Collens, Ramille Shah, and Adam Jakus spent years developing an innovative technology to regenerate injured bone. The results, they thought, were . . . okay. The company they founded, Dimension Bio, received clearance from the Food and Drug Administration for its approach: providing a 3D-printed lattice or "scaffold" for new bone to grow in. However, it didn't form new bone fast enough to compete with established treatment methods, such as transplanting a patient's own bone tissue."
"But Collens, Dimension's CEO, sees the experience as a net positive, validating the company's technology and processes with the FDA. That could help the Chicago-based startup work toward a more-ambitious goal in about three years: building a human liver using its scaffold and donated cells. It would actually be a miniature, simplified version of the organ, meant to function well enough to keep someone alive."
"According to the Centers for Disease Control and Prevention, 52,222 people died of liver disease and cirrhosis in 2023. The death rate from cirrhosis increased 26.4% from 2000 to 2019, per the National Institutes of Health. (Cirrhosis is most often the result result of fat buildup, viral hepatitis B and C, or long-term alcohol abuse, though there are other causes.)"
Three founders developed a 3D-printed approach to regenerate injured bone using PLGA scaffolds. The scaffold system received FDA clearance but produced new bone more slowly than autografts, limiting clinical competitiveness. The company considers the FDA validation valuable for processes and technology. The firm intends to leverage its 3D printing platform and FDA experience to create a simplified, cell-seeded miniature human liver within about three years to sustain patients temporarily. Liver disease and cirrhosis caused over 52,000 deaths in 2023 and rising mortality increases clinical need for bridging therapies. A miniature liver could buy time for healing or transplantation.
Read at Fast Company
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