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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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ARPA-H Is Funding the Regeneration of Human Joints, and the Biofabrication Implications Go Further Than Osteoarthritis
More than 500 million people worldwide live with osteoarthritis, a degenerative joint disease that progressively destroys cartilage and bone until the joint is no longer functional. Current treatment endpoints, anti-inflammatory drugs, steroid injections, and eventual joint replacement surgery, address the symptoms of that destruction rather than reversing it. The Advanced Research Projects Agency for Health…
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The $150 Bioprinter Extruder That Anyone Can Build
Most conversations about biofabrication focus on what the technology might eventually produce, organs, tissue implants, patient-specific grafts. Fewer focus on the practical question of who can actually access the tools to do that work. A previous paper published in HardwareX and available open-access via PubMed Central addresses that question directly, by publishing the full design…
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Cellbricks Therapeutics Raises €10M to Advance Biofabricated Tissue Implants for Wound Care and Reconstructive Surgery
A Berlin and Boston-based tissue engineering company has raised €10 million to move living, vascularized human tissue implants through preclinical validation and closer to patients. Cellbricks Therapeutics announced the financing on March 25, 2026, framing it as the capital needed to do the hard translational work the field has long demanded but rarely seen executed.…
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The Business of Biofabrication 