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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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CTIBIOTECH Lands €1.25M from France 2030 to Industrialize 3D Bioprinted Tumors, and Take Aim at Oncology’s 95% Failure Problem
A Lyon-based CRDMO is betting that automated, patient-specific microtumors can fix the broken economics of cancer drug development. The French state just bought in. Ninety-five percent of new cancer drugs fail in human clinical trials. That single number, recited in every oncology pitch deck for the better part of a decade, is the foundation under…
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restor3d’s Aeros Ankle System Goes Full Commercial, 3D-Printed Orthopaedics Hits the Clinic
restor3d launched full commercial availability of its Aeros Modular Stem Ankle System on April 2, 2026, and it’s worth paying attention, even if orthopaedic implants sit at the more prosthetic end of the biofabrication spectrum. The story here is about what happens when additive manufacturing moves from prototype to operating theatre at scale. What Aeros…
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Miromatrix’s miroliverELAP Earns RMAT Designation
Miromatrix, a company owned by United Therapeutics, has secured Regenerative Medicine Advanced Therapy, RMAT, designation from the FDA for its miroliverELAP program. The therapy is a biofabricated external liver assist device built on decellularized porcine scaffolds seeded with human cells. It marks an important regulatory step forward, and one worth paying close attention to for…
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Hyalex Secures 510(k) Clearance for Cartilage-Mimicking Implant, Advancing Synthetic Biomaterials into Market
Hyalex Orthopaedics has received FDA 510(k) clearance for the HYALEX Slalom implant — built on its proprietary Hydrosurf biomaterial that mimics articular cartilage — and is launching commercially in the U.S. foot-and-ankle market.
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XellSmart Launches Phase II Trial of Off-the-Shelf iPSC Cell Therapy for Parkinson’s
XellSmart’s allogeneic, off-the-shelf iPSC-derived dopaminergic cell therapy XS411 enters a multicenter Phase II registrational trial — one of the most advanced iPSC manufacturing programmes in a registrational study anywhere in the world.
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Eli Lilly Pays Up to $7B for Kelonia’s In Vivo CAR-T Platform and What It Means for Cell Therapy Manufacturing
Eli Lilly is acquiring Kelonia Therapeutics for up to $7B for its in vivo CAR-T platform that programs T-cells inside the body — bypassing ex vivo manufacturing entirely and signalling where the cell therapy sector is heading.
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OHSU Secures $9.2M NIH Grant to Advance Bone Cancer Organs-on-Chips Research
Oregon Health & Science University has secured a $9.2 million federal grant from the National Institutes of Health to develop next-generation organs-on-chips technology aimed at advancing research into bone-related cancers. The work will be led by researchers at OHSU’s Knight Cancer Precision Biofabrication Hub, where scientists are focused on recreating complex tumor-bone interactions in the…
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Linton Lifesciences Launches Biofabricated NAMs: Rebuilding the Missing Layer Between Biology and Decision-Making
In drug discovery and medical device development, the most expensive failures rarely come from bad ideas, they come from bad models. For decades, the industry has relied on a patchwork of 2D cell cultures, simplified organ-on-chip systems, and animal models to approximate human biology. Each has contributed something. None have fully captured what matters most,…
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The Business of Biofabrication 