Evolved.Bio
Bioassembloids · Anchored Cell Sheet Engineering

Organs, by design.

We grow scaffold-free tissue building blocks from cells alone, then assemble them bottom-up into multi-tissue bioassembloids. One platform for every organ, in vitro and in vivo. Our lead program is a one-time, permanent bioassembled pancreas for Type 1 Diabetes.

SheetAnchored at 4 points
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The problem

Millions of organs are needed every year. Complex ones remain out of reach.

Stem cell injections fail to regenerate damaged organs, and tissue-engineered products are limited to simple tissues like skin, bone and cartilage. The answer sits between too simple and too complex.

The platform

Anchored Cell Sheet Engineering

Cells grow on engineered surfaces, secrete and organize their own extracellular matrix, and are then guided by anchors to remodel into mature 3D building blocks. No scaffolds, bioinks or animal-derived matrices are added at any step.

No exogenous biomaterial
Scaffold-free

No foreign body reaction, no degradation byproducts and no xenogeneic risk. Native cell–cell and cell–ECM interactions stay intact.

Shape by tension
Anchor-guided

Anchors on nano- to micro-patterned flexible membranes set the shape, mechanics and dimensions of each construct. Release needs no temperature change or other trigger.

One process
Tissue-agnostic

The same process works across cell types and tissues, and fits existing clinical workflows from standard expansion to implantation by standard surgery.

Weak · immatureTraditional cell sheetsSince the 1990s
Stem cells on a flat 2D surface
Cells grow in 2D
Cells differentiate into a sheet and deposit ECM
Sheet deposits ECM
Released sheet crumples on the plate
Released sheet crumples
Mature · relevant formAnchored cell sheetsEvolved.Bio
Stem cells seeded around four anchors
Cells grow around anchors
Sheet matures while held by anchors
Matures under tension
Aligned, structured tissue held between anchors
Remodels into a building block
The toolbox

Every building block an organ needs.

Sheets, fibers, spheres, and hollow tubes and spheres with a preserved lumen. Each one forms in three to four weeks and is the most in vivo-like version of that form factor, because nothing in it came from outside the cells.

Bioassembly

Snap the blocks together. Let the body finish the last mile.

Building blocks are assembled bottom-up, like LEGO, into multi-tissue bioassembloids. They carry enough structural and functional complexity for long-term stability, then integrate and complete regeneration in vivo.

LungNative lung beside a version bioassembled from building blocks
LiverNative liver beside a version bioassembled from building blocks
HeartNative heart beside a version bioassembled from building blocks
PancreasNative pancreas beside a version bioassembled from building blocks
Reproductive tractNative reproductive tract beside a version bioassembled from building blocks
BrainNative brain beside a version bioassembled from building blocks
Native
Bioassembled
3–4weeks

to form a mature building block

30–40days

to produce a complex organ such as a pancreas

0%

exogenous biomaterial in any construct

2042

granted US patent term, one of four patent families

Step 1

Cell proliferation

Hyperflasks or bioreactors expand cells to the target requirement.

Step 2Evolved

Cell culture

Gold-standard 2D differentiation inside Evolved's custom culture cassettes.

Step 3Evolved

Biofabrication & bioassembly

Cell-guided self-assembly forms fully structured tissues, then multi-tissue constructs.

Step 4

Implantation & regeneration

Standard surgery, no extra training, complete biological integration.

Lead program · Type 1 Diabetes

A bioassembled pancreas. One procedure, for good.

A pancreas broken down into tissue-specific building blocks and reassembled into a bioassembled pancreas
Native organTissue-specific building blocksBioassembled organ
~9M

people live with T1D worldwide; prevalence is expected to double in 15 years

1.7M

people with T1D in the United States

$30B

spent on T1D in the US every year

10–15yrs

of life expectancy lost, even with insulin therapy

Native pancreas on the left, bioassembled pancreas built from modular blocks on the right Native pancreasBioassembled

Ectopically implanted β-cell clusters have been tried again and again for three decades. We rebuild the organ's architecture instead, with the hardest parts already de-risked.

  • Proven path from iPSCs to every cell type the organ needs.
  • All major components already optimized in their proper form factors.
  • Fully allogeneic, designed to work without immunosuppression.
  • A permanent, one-time treatment instead of a lifetime of repeat therapy.

The same product can serve other high-value indications such as type 2 diabetes and obesity. Programs like this are eligible for FDA Fast Track and RMAT and EMA PRIME designation.

Evidence

Validated in vivo. Benchmarked in vitro.

Most of our data so far is in skeletal muscle, the proving ground for the platform.

Muscle-specific acellular ECM fibers repair volumetric muscle loss

Our simplest product, in vitro-made and decellularized muscle ECM fibers, was tested in rat models of volumetric muscle loss against a commercial porcine ECM.

  • Preserved muscle mass
  • Controlled inflammation and fibrosis
  • Promoted vascularization
  • Supported new muscle fiber formation

Acta Biomaterialia · 2025 · open to partnering this program

Animal-derived scaffold
Injured muscle
Scaffold implanted
Partial remodeling
Fibrotic, partially repaired muscle
ACSE ECM fibers
Injured muscle
ECM fibers implanted
Fibers guiding regeneration
Fully regenerated muscle
InjuryImplantRemodelOutcome
Animal-derived scaffold
ACSE ECM fibers
Pipeline

Beyond organ regeneration.

The same building blocks deliver cells, produce tissue-specific secretomes and model disease. Near-term programs generate revenue while the pancreas advances.

Program
Discovery
Preclinical
Clinical
Commercial
Time to market

Organ regeneration

Multi-tissue bioassembloids for skeletal muscle and pancreas, implanted by standard surgery.

Cell & gene therapy delivery

A delivery system with better engraftment and retention than injection.

Longevity products

Exosomes, EVs, mitochondria and ECM from mature 3D constructs: more tissue-specific content and steadier long-term output than 2D culture.

In vitro models

High-relevance tissue models and a skeletal muscle kit for drug discovery.

Manufacturing intelligence

Built to become a tissue foundry.

Machine learning

Optimized on proteomic and imaging data

A multimodal model steers each process toward physiological relevance, speed and quality.

Automation

Closed-loop, stand-alone manufacturing

Proof of concept for an automated, closed-loop system that runs the whole process.

IP

Four patent families

Including a granted US patent valid to 2042, covering the anchored platform.

Today203020352042
Regulatory

A short path to the clinic

ACSE is a strong candidate for FDA Advanced Manufacturing Technology designation, and our lead indications are positioned for expedited pathways.

AMTPlatformFast TrackPreclinicalRMATAfter phase 1PRIMEEMA
Team

Founded by the people who built the platform.

AS
Alireza ShahinCo-founder
JC
John CappuccittiCo-founder
Where ACSE started Our first application was cultivated meat: fully structured, scaffold-free meat grown with the same anchored process. We have since moved to human tissues and organs, and kept the habit of engineering for cost, speed and scale.
Join us

Let's help hundreds of millions of people heal, for good.

Partner, invest or collaborate with us on the world's first tissue foundries for in vivo-like tissues.

info@itsevolved.com
Investors
Maple Leaf Foods Big Idea Ventures Garage Capital Saltagen Ventures Angel investors
Grants & support
Velocity Incubator Ontario Genomics Intellectual Property Ontario (IPON) Elevate IP