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  Next-Gen Tools

Five Companies Leading the Way in 3D Bioprinting

by Dana Sokolova  (contributor ) , Anastasiia Rohozianska   •   Nov. 4, 2025

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Lately, bioprinting is shifting from proof-of-concept prints to regulated workflows and early clinical use. In July 2022 in San Antonio, Texas, surgeons performed the first human ear reconstruction using a patient-matched, 3D-bioprinted living tissue implant—developed by PrintBio (formerly 3DBio Therapeutics) from the patient’s own cartilage cells.

3D bioprinting uses additive manufacturing to place living cells and biomaterials (bioinks) layer by layer under computer control, forming tissue-like structures such as skin, cartilage, vasculature, and organ-on-a-chip models. Today, the most common uses are laboratory tissue models for drug discovery and disease research; fully transplantable, vascularized organs remain an R&D goal rather than a clinical product. 

Bioprinted constructs rely on more than cells: printable hydrogels and scaffolds must support oxygen and nutrient diffusion, enable maturation (often in bioreactors), and in some cases integrate with host vasculature after implantation. Materials such as collagen and biodegradable polymers are used to tune mechanical properties and cell behavior. 

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AI in Drug Discovery Report 2025

In the U.S., more than 100,000 people are on the organ waitlist and about 13 people die each day while waiting—figures that keep interest high in regenerative and tissue-replacement approaches. According to the Global Observatory on Donation and Translation 2023 report, worldwide, about 172,000 solid-organ transplants were performed that year—roughly one-tenth of estimated need. 

In April 2025, the FDA outlined a plan to phase out some animal-testing requirements and encourage validated AI and human-based ‘new approach methodologies’, including bioprinted tissues and organ-chip models for IND submissions, reinforcing demand for standardized, human-relevant in vitro systems. 

Prospects are most concrete in skin, cartilage, and soft-tissue reconstruction, plus drug discovery models; for now, complex, fully vascularized solid organs remain a long-term goal. Notably, in August 2024, Harvard’s Wyss Institute unveiled co-SWIFT, a 3D bioprinting method that prints multilayer, perfusable blood vessels within dense cardiac tissues, producing synchronously beating, drug-responsive constructs—bringing the field closer to printing vascularized, transplant-ready organs.

Recent surveys still find few interventional trials involving bioprinting, but platform advances like embedded/extrusion strategies for perfusable constructs and more mature bioinks, are widening feasible tissue sizes and functions. Against ongoing transplant shortages, incremental clinical grafts and better human-model data are the near-term trajectory.

Against that backdrop, the article follows where progress is tangible: standardized printers and workflows, clinical-grade bioinks and constructs, and early patient-specific implants and lab models. We focus on five companies, each making contributions towards advancing regenerative medicine, personalized healthcare, and the potential for manufacturing functional human tissues. 

Cellink

Founded in 2016 and headquartered in Gothenburg, Cellink, the bioprinting brand within BICO Group, is offering high-tech bioprinting equipment and driving advancements in cell printing and research collaborations.

Cellink offers extrusion and light-based bioprinters to design, print, and document live-cell constructs:

  • BIO X and BIO X6: Syringe-based extrusion bioprinters with multiple simultaneous printheads to deposit different cells/materials in one build, with controls for temperature, pressure, and light to gently solidify gels.
  • BIO ONE: Simplified extrusion system for routine prints and teaching labs.
  • LUMEN X and BIONOVA X: Projected light (DLP) light-based printers for fine features (e.g., porous scaffolds, microchannels) via high-resolution photopolymerization.
  • DNA Studio 4 (+Vault): End-to-end software for model generation, simulation, G-code editing, draw-and-print, protocol saving, and print reporting; Vault adds authorization/authentication/validation for compliant digital records from preclinical to clinical.
  • Quantum X bio: Two-photon polymerization system printing from nanoscale to millimeter scale; supports live-cell/bioresin printing on chips, slides, or culture dishes in a sterile, temperature-controlled chamber.

CELLINK also supplies ready-to-use bioinks and software so labs can import a design, choose a material, and print skin, cartilage, or organ-on-chip models.

In line with their commitment to sustainable practices and supporting the United Nations' Sustainable Development Goals, Cellink applies a sustainable business model through their STEP (the Sustainable Tissue Engineering Program) program, which applies 3R principles (replacement, reduction, refinement) to increase the use and accuracy of non-animal disease models. On many of their products, a “sustainability symbol” links via QR code to plain-language notes on how each tool contributes to health and well-being efforts. Their Responsible Return Program takes back older bioprinters for refurbishing or recycling, with refurbished units redeployed to broaden access to bioprinting in more labs.

VivoSim Labs

VivoSim Labs (formerly Organovo) builds multicellular, scaffold-free human tissues with its NovoGen bioprinting platform and uses those 3D disease models to select and de-risk drug programs. 

The company develops human-relevant NAMkind 3D liver and intestinal toxicology models  built from primary human cells with species-specific variants and modular assay panels to detect true human toxicity signals early, guide selection of predictive animal models, and support IND narratives.

  • NAMkind Liver: Human 3D liver model (hepatocytes+Kupffer+stellate cells) designed to detect hepatotoxicity across immune-mediated and fibrosis pathways; reports 87.5% sensitivity to known Drug-induced liver injury- (DILI)causing drugs and 100% specificity, helping researchers make earlier toxicity decisions while lowering the chance of incorrectly flagging safe compounds.
  • NAMkind Intestine: 3D Transwell with epithelial and stromal compartments to capture cytokine-driven inflammation and diarrhea risk missed by monolayers. It measures TEER (transepithelial electrical resistance)—a way to check how well the gut barrier holds together—and tracks cell health in different layers, giving a more realistic picture of how medicines affect intestinal function.

In February 2025, Eli Lilly acquired then-Organovo’s FXR program, including FXR314—an oral FXR agonist for ulcerative colitis—after the candidate was developed and evaluated using Organovo’s 3D bioprinted human tissue models, which informed the clinical strategy and helped de-risk the program. 

Aspect Biosystems

Aspect Biosystems is a Canadian biotechnology company that develops bioprinted tissue therapeutics (BTTs)—implantable, cell-based constructs designed to replace or supplement endocrine and metabolic functions. Their “full-stack” platform combines AI-powered bioprinting, computational tissue design, therapeutic cells, and advanced biomaterials to produce implantable, retrievable tissues that replace or supplement lost function.

Aspect Biosystems’ partnered diabetes/obesity program with Novo Nordisk with $75 million upfront payment entails pancreatic BTTs built from allogeneic stem-cell islet clusters encapsulated in immune-protective materials, intended to maintain glycemia without immunosuppression. Other programs include rare-endocrine franchise with adrenal BTTs using human adrenocortical cells (preclinical), and a liver program for acute liver failure using stem-cell hepatocytes (preclinical). 

In January 2025, Aspect Biosystems raised a $115M Series B led by Dimension and joined by Novo Nordisk and others to advance its bioprinted tissue therapeutics toward the clinic.

PrintBio

New York-based PrintBio develops surgeon-collaborated, clinically tested bioprinting solutions for soft-tissue repair and reinforcement, centered on a programmable surgical mesh portfolio and a platform for living tissue implants. The company combines regenerative medicine, advanced materials, and engineering, and operates a full bioprinting stack built to align with FDA therapeutic manufacturing requirements.  

PrintBio’s therapeutic bioprinting stack, built for cGMP/FDA needs, combines ColVivo therapeutic-grade bio-ink (carries living cells), the GMPrint 3D bioprinter with aseptic workflow, single-use kits, CFR Part 11 software and AI tool-path planning (>10 million cells/min), proprietary cell extraction/expansion methods, and a bioresorbable Overshell that adds temporary structural support to living implants, the basis of 3DMatrix.

PrintBio markets two FDA-cleared, 3D-printed resorbable meshes for soft-tissue reinforcement in plastic/reconstructive surgery—DynaForm (cleared as ‘3DMatrix Surgical Mesh’ May, 2024) and DynaFlex (cleared as ‘3DMatrix DynaFlex’ May, 2025).”

DynaFlex is a knot- and weave-free mesh intended to maintain pore geometry under tension and support fluid transmission, while avoiding cross-filament features typical of filament meshes. DynaForm provides customized 3D constructs that conform to patient anatomy for immediate soft-tissue support and a foundation for longer-term strength. Both products apply the company’s materials and engineering stack to match mechanical behavior to the clinical site rather than forcing a single, static mesh design.

On June 2, 2022, 3DBio Therapeutics and the Microtia-Congenital Ear Deformity Institute reported the first human ear reconstruction using AuriNovo, a patient-matched 3D-bioprinted living tissue implant made from the patient’s own cartilage cells. The ongoing Phase 1/2a trial is enrolling microtia patients in San Antonio and at Cedars-Sinai and assesses safety and preliminary efficacy. Additionally, AuriNovo holds FDA Orphan Drug and Rare Pediatric Disease designations.

Precise Bio

Precise Bio, founded in 2016, develops a 4D biofabrication platform for transplantable tissues and, longer term, organs, combining cell expansion, biomaterials, controlled processes, and printing technology. Unlike conventional 3D bioprinting that yields a fixed structure, 4D adds time, with constructs programmed to mature and change after printing through cell remodeling or stimuli-responsive materials. The system is built to produce complex tissues reproducibly and to transfer learnings from one tissue type to another, accelerating product development in various healthcare sectors.

Precise Bio’s ophthalmology unit is building biofabricated ocular tissues, led by a printed corneal graft intended to replace donor tissue in Descemet’s Stripping Endothelial Keratoplasty (DSEK), Descemet’s Membrane Endothelial Keratoplasty (DMEK), and Penetrating Keratoplasty (PK) procedures; the group reports first-in-animal corneal graft transplants and targets higher endothelial cell density, optical transparency, and mechanical strength. 

The effort addresses a reported global shortfall—about one donor cornea for every 70 needed. It also extends to a pipeline that includes a cell-based retinal patch for Age-related Macular Degeneration (AMD), vision-correction lenticules, and constructs for ocular surface disorders developed with partners. Besides ophthalmology, Precise Bio extends its platform with a 3D cardiac tissue patch for post-myocardial infarction repair, while evaluating additional programs in orthopedics, dental, skin, and wound care.

Currently, Carl Zeiss Meditec and Precise Bio are in a partnership to co-develop 4D biofabricated corneal tissues—one for endothelial keratoplasty and one for natural lenticule transplants used in keratoconus/vision correction. Zeiss is investing, funding further development, and holds exclusive worldwide commercialization rights to these two cornea products.

Topic: Next-Gen Tools

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