The Business of Biofabrication

Vivodyne is not growing whole replacement organs. Instead, the California company is building large, vascularized human tissue models and surrounding them with the automation needed to run thousands of experiments at once.

That distinction matters. A recent MedCity News examination of New Approach Methodologies compared three different levels of human-based preclinical testing: Revalia Bio’s perfusion of donated whole human organs, Vivodyne’s lab-grown vascularized tissue models, and Emulate’s organ-on-a-chip systems. Each format addresses a different part of the drug-development process rather than serving as a direct substitute for all the others.

Vivodyne’s models contain approximately 200,000 to 500,000 cells and develop self-assembled, tissue-specific vascular networks that can be perfused. The company uses them to study drug transport, cellular responses, vascular changes, toxicity, and other effects that are difficult to reproduce in conventional two-dimensional cell culture.

Its commercial argument, however, is based as much on automation as biology. Vivodyne’s HIVE platform automates the seeding, cultivation, dosing, imaging, sampling, and extraction of as many as 10,000 independent tissues. Once loaded with reagents, the enclosed robotic system can operate continuously, generating imaging, sequencing, proteomic, and other experimental data without the same level of manual intervention required by many academic tissue-model workflows.

Vivodyne has licensed 20 tissue models, with roughly five to seven adapted to the HIVE platform, according to MedCity. The company was founded in 2021, is based in Brisbane, California, and has raised a reported $40 million Series A led by Khosla Ventures. It also says it works with major pharmaceutical companies, although those customers and the scope of their programs have not been publicly detailed.

Why it matters for biofabrication

Biofabrication companies often emphasize how closely a model resembles human tissue. Pharmaceutical customers also care about whether the model can be produced consistently, operated at sufficient scale, and integrated into existing drug-development workflows.

Vivodyne is trying to solve both problems at once. Its tissues are larger and more biologically organized than basic spheroids, while the HIVE is intended to turn tissue production and testing from a specialized manual process into a repeatable industrial workflow.

That positioning arrives as the FDA expands its support for NAMs. The agency’s 2025 roadmap highlighted organoids, organ-on-a-chip platforms, and computational models as tools that could reduce animal testing, while a March 2026 draft guidance outlined a general validation framework for using NAMs in drug development. The policy direction is favorable, but regulatory acceptance will still depend on validation within defined contexts of use rather than a blanket endorsement of any particular platform.

The business read

The competition is not simply between organoids, tissue chips, and whole organs. It is a competition to determine which model delivers the right combination of human relevance, throughput, cost, and regulatory confidence for a particular decision.

Vivodyne’s long-term advantage may therefore come from its manufacturing system and its dataset rather than any single tissue model. If HIVE can generate standardized human-response data across thousands of experiments, the company could become both a preclinical testing provider and an important data supplier for pharmaceutical AI. The real proof will be whether those results predict human outcomes more reliably than the animal and in-vitro methods they are intended to replace.

Source: MedCity News, July 8, 2026, with supporting information from Vivodyne, Helena, and the FDA.