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Linton Lifesciences and ClonalStem Explore Engineered Environments for Vascular Cells
Biofabrication rarely advances through hardware, biomaterials, or cells alone. The more interesting opportunities often emerge when those capabilities come together around a specific biological question. That is something Linton Lifesciences and ClonalStem have recently been exploring through work involving cord-blood-derived endothelial colony-forming cells (CB-ECFCs) and engineered biomaterials for vascular applications. The work looks at how…
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Pluristyx Is Building the Manufacturing Layer Behind Biofabricated Liver Therapies
The headline is liver tissue in space. The more important development may be happening on Earth. Pluristyx, the Wake Forest Institute for Regenerative Medicine, Innovian Space and the RegenMed Development Organization are working together to develop a standardized manufacturing workflow for clinical-grade hepatocytes derived from induced pluripotent stem cells. The immediate objective is to create…
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Tides Medical’s APLICOR 3D Used for World’s First 3D-Printed Breast Fat Graft
The procedure takes 3D bioprinting beyond chronic wound care and into reconstructive surgery—while offering a glimpse of what point-of-care biofabrication could look like in practice.
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Bruker Just Bought Control of MIMETAS, and With It, a Seat at the Center of the NAMs Transition
A $3B analytical instruments company taking majority ownership of the leading organ-on-a-chip platform is the clearest signal yet that microphysiological systems have graduated from scientific promise to strategic infrastructure.
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Humacyte Advances Bioengineered Coronary Vessel Into First Human Study
Humacyte has received FDA acceptance of its Investigational New Drug application for a first-in-human study of its coronary tissue-engineered vessel, or CTEV, in coronary artery bypass grafting. The company plans to begin a Phase 2a study during the third quarter of 2026. The trial will enroll ten adults with coronary artery disease and evaluate the…
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Paragonix’s KidneyVault Pushes Organ Preservation Beyond Geographic Limits
Two donor kidneys transported from Hawaii to the East Coast have demonstrated how portable perfusion technology could expand the geographic reach of the U.S. transplant system. The kidneys, recovered from the same donor at The Queen’s Medical Center in Honolulu, were transported to separate recipients in New York City and Hartford, Connecticut. The journeys covered…
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Auxilium Bioprints Kidney and Liver Tissue in Orbit—and Tests a Multi-Product Manufacturing Model
Auxilium Biotechnologies bioprinted kidney, liver, and cartilage tissue aboard the ISS during Mission AXLM-3 — a test of whether orbital manufacturing can support multiple biomedical products at once, not just a single scientific demonstration.
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STEMCELL Technologies and CCRM Build a Matched iPSC Path from Research to GMP
STEMCELL Technologies and CCRM are pairing research-use-only and GMP-grade iPSC lines from the same donor material — an infrastructure play that lets cell therapy developers commit to a starting line early without rebuilding their platform later.
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TREGZI and the Business of Precision-Built Cell Therapies
The FDA’s approval of Orca Bio’s TREGZI marks an important moment for transplant medicine, but it may be an even bigger signal for the business of biofabrication. On June 30, 2026, the FDA approved TREGZI, also known clinically as Orca-T, for adults with hematological malignancies undergoing matched-donor hematopoietic stem cell transplantation with a myeloablative preparative…
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BellaSeno’s Mentor/J&J Collaboration Signals a New Chapter for Regenerative Soft-Tissue Implants
BellaSeno’s newly announced worldwide collaboration with Mentor Worldwide LLC, part of Johnson & Johnson MedTech, is more than a company milestone. It is a signal that regenerative soft-tissue restoration is moving closer to mainstream medtech commercialization. Founded in 2015, BellaSeno has spent nearly a decade developing a bioresorbable scaffold platform for soft-tissue and structural tissue…
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The Business of Biofabrication 