Enabling research from start to finish

Bring us the material. We’ll help you ask the right question.

PoC, feasibility, material studies, preclinical work or post-market surveillance. Bring us the biomaterial or device and we’ll design and run the full implant study, or send the biopsy and we’ll take it from histological processing through analysis and reporting.

Unified under one quality system, delivering data in a form that investors, grant officers and regulators can actually use.

Discuss a study See our research streams
GLPaligned methodology
ISO/IEC 17025accredited QM
End-to-endscoping → dossier
Live · Material study · 90 d Histology cross-section, resin embedded, 20 µm scale 20 µm
Resin-embedded biomaterial cross-section

How we work

Consult. Enable. Generate.

Three modes, one continuous engagement. We sit down with your team first, shape the study around the decisions you need to make, and then execute.

01, Consult

Talk to a scientist, not a salesperson.

We start with your endpoint, whether that’s a CE submission, an investor data room, an FDA predicate comparison or a grant milestone. The study gets built backwards from there.

  • Study scoping & protocol authoring
  • Endpoint & timepoint selection
  • Predicate & control benchmarking
  • Grant work-package drafting
02, Enable

Single front door for the full investigation.

Other labs only investigate a biopsy. We coordinate the whole investigation: from research consultation, to implantation, to in-depth analysis and dossier-ready reporting. Feasibility studies run through our university partner network; preclinical studies through our GLP-certified colleagues. And when the device or anatomy calls for it, we engage specialist surgeons from a curated network, matched to your device class. One point of contact, one quality system, end to end.

  • Regulatory grade, GLP certified or GLP aligned investigations
  • Specialist surgeons matched to device class
  • End-to-end study coordination
  • One quality standard.
03, Generate

Data your stakeholders can actually act on.

Histopathology, quantitative histomorphometry, IHC panels and interpretive reports. Written for the audience reading them, not the lab that produced them.

  • Investor & grant milestone reports
  • ISO 10993-6 semi-quantitative scoring
  • Bone­-implant contact & biodegradation
  • Publication-ready figures & tables

What we accept

From material
to market.

If you can hand us a sample we can build a histological investigation around it. Biomaterial candidates, polymer formulations, alloy specimens, hydrogel matrices, drug-eluting constructs, retrieved devices, processed tissue.

Bone substitutes & scaffolds

Calcium phosphates, granules, putties, 3D-printed scaffolds.

Collagen & soft-tissue matrices

Crosslinked membranes, dermal substitutes, ECM scaffolds.

Polymers & hydrogels

Resorbable, drug-eluting, injectable, photo-crosslinked.

Titanium & metallic implants

Dental, orthopaedic, custom alloys, surface-treated.

Stents & vascular constructs

Bare-metal, polymer-coated, drug-eluting, bioresorbable.

Ophthalmic & ocular devices

IOLs, sclera-contact constructs, drug-delivery inserts.

Combination products

Device + drug, device + biologic, multi-modal constructs.

Post-market retrievals

Retrieved devices, vigilance investigations, adverse-event analysis.

Research streams

Four ways we enable your science.

Whether you’re screening a first-generation material, refining a new processing technique, or running a structured preclinical evaluation, we shape the work around your question and run it under one quality system.

10×
01 Early stage & Innovation

PoC & feasibility studies

A prelude to full preclinical investigation. First-look studies that answer narrow, specific questions before you commit to a larger development course. We use them for material screening, for pure device investigation, and for head-to-head comparison against a predicate device or sham control. The point is a clean go / no-go signal at a fraction of the cost of a full study.

Typical questions
Material screening Pure device investigation Predicate / sham comparison Degradation & tissue response
Suited to

First-generation materials, early-stage start-ups, due-diligence read-outs, or any team preparing to step into a full preclinical programme.

20×
02 Materials and Processing

Material & processing studies

Compare formulations, surface treatments or processing methods head-to-head. Or develop a custom workflow for newly developed materials where the standard playbook doesn’t fit. We build the embedding, sectioning and staining around the sample.

Typical investigations
Head-to-head formulations Surface-treatment comparison Novel processing techniques Custom embedding workflows
Suited to

R&D teams optimising formulations, materials scientists, manufacturing-process owners.

40×
03 Regulatory grade (FDA & EU MDR)

Preclinical investigations

Preclinical research to support regulatory body submissions. GLP- and 17025-aligned workflows, or full GLP and 17025 protocols for larger investigations that need to stand up to FDA or EU MDR review.

Evaluation contexts
Soft-tissue response Tissue regeneration Novel materials & devices ISO 10993-6 scoring
Suited to

Device manufacturers preparing 510(k), PMA or CE/MDR submissions.

60×
04 Post market - Clinical

Clinical Biopsy Analysis

For post-market surveillance studies and investigations: histological analysis of clinical biopsies, explanted and retrieved devices already on the market. We characterise long-term tissue response, in-vivo degradation and integration in real-world specimens to support EU MDR post-market surveillance, PMCF and field-complaint investigations.

Typical investigations
Explant & retrieval analysis Long-term tissue response In-vivo degradation Field-complaint investigation
Suited to

Manufacturers running EU MDR post-market surveillance, PMCF studies, or investigating retrieved devices and field complaints.

Study design

Bend the protocol around your question.

We start with what you need to learn, then design backwards. Single-arm or multi-arm, single timepoint or multi-timepoint, with controls or without.

Scope a custom protocol

Customised protocols

Built from your endpoints, your indication and your regulatory destination. Not a template.

Single-arm or with control & sham

Lean evaluation when you need a fast read-out; controlled comparison when you need defensible evidence.

Multi-timepoint designs

4, 8, 12, 26 or 52 weeks. Degradation kinetics and remodelling, not a single snapshot.

FDA-acknowledged predicate comparison

Head-to-head against the predicate device you’re positioning against in the submission.

Proof of concept & biodegradation

First-in-tissue feasibility, degradation profile, integration window, regeneration trajectory.

Investor & grant-milestone-ready data

Reports scoped to the decision they support, whether that’s due diligence, a Series-A data room, an EIC milestone or a Notified Body file.

Partner network

Two tiers of preclinical capacity, one front door.

We facilitate the investigation around your device or material. The right partner programme gets engaged for the question you’re actually trying to answer, then the work comes back to our Berlin lab under one quality system.

Tier 01 · Research-grade

University partner programme

For feasibility & proof of concept

A long-standing research partnership with an established university programme. Cost-effective with accelerated lead times, suited to early-stage questions where you need a clean signal fast, not regulatory weight.

  • Cost-effective for early-stage programmes
  • Accelerated lead time from sample to study start
  • Best fit: feasibility, PoC, material screening
  • One quality system
Tier 02 · GLP-grade

GLP-certified contract laboratory

For regulatory & pivotal evidence

A partnership with a GLP-certified contract laboratory based in Germany. It covers the full preclinical scale for studies destined for regulatory submission, and it’s built for evidence that has to withstand reviewer scrutiny.

  • Full GLP-certified study execution
  • Capacity across the full preclinical scale
  • Regulator-ready documentation & audit trail
  • Best fit: 510(k), PMA, CE/MDR submissions
And the hands on the work

A curated network of specialist surgeons, matched to your device class.

Whichever indication your device targets, whether dental, orthopaedic, cardiovascular, ophthalmic or soft-tissue, we engage clinicians experienced with that anatomy and that device type. The quality of the investigation isn’t capped by whoever happens to be on-site.

Example outputs

Real data from real studies.

Representative micrographs from feasibility-study deliverables, covering integration, immune response and biodegradation. Every image is paired with quantitative readouts and a pathologist’s interpretation.

Movat-P · 90 d Movat pentachrome stained section showing bone integration around biomaterial
Bone substitute · 90 d

Tissue integration of a calcium phosphate bone substitute materials

Movat pentachrome at 90 days. New bone formation (yellow), residual material and surrounding connective tissue, all quantified by histomorphometry.

IHC · CD163 · 90 d CD163 immunohistochemistry of macrophage response around collagen matrix
Collagen membrane · 90 d

M2 macrophage response to a crosslinked collagen membrane

CD163 immunohistochemistry quantifying pro-regenerative macrophage polarisation around the membrane. An early biocompatibility signal worth catching before you commit further.

von Kossa · 30 d von Kossa stained section showing bone tissue ingrowth into a collagen matrix
Bone substitute · 30 d post-implantation

Bone tissue ingrowth into a collagen matrix

von Kossa stain at 30 days post-implantation, evaluating bone substitute material integration. The visual half of the integration story, alongside the quantitative half.

What you receive

Deliverables that move the next decision.

Not a slide deck on a shelf. We write each report for the audience that will read it, whether that’s investors, programme officers, notified bodies, or your own scientific board.

Written forInvestors

Investor data-room package

Diligence-ready figures, a narrative summary, materials & methods, and a one-page TL;DR your reviewers can act on.

Diligence figuresNarrativeMaterials & methodsOne-page TL;DR
Written forGrant officers

Grant-milestone report

Mapped to your EIC, BMBF, ZIM or Horizon-Europe deliverable structure, co-authored where that helps the case.

EICBMBFZIMHorizon Europe
Written forRegulators

Regulatory-aligned dossier

ISO 10993-6 semi-quantitative scoring and a GLP-aligned narrative, structured for 510(k), PMA or CE/MDR submission.

ISO 10993-6510(k)PMACE/MDR
Written forJournals

Publication-ready figures

High-resolution, scale-barred micrographs, with co-authorship and methods drafting on request.

Hi-res micrographsScale-barredCo-authorshipMethods drafting
ISO/IEC 17025 accredited
GLP-Certified methodology
Single chain of custody
Hard, soft & combination tissue capable
NDA-first conversations

Start the conversation

Tell us what you’re building. We’ll tell you the right study.

NDA-first conversations. First scoping call within one business day, study proposal within five.

Talk to a scientist Read our publications
Custom protocol design Single-arm or controlled study formats Investor- and grant-aligned reporting