PoC & Feasibility Studies
Generating in-vivo evidence on implant function, immune response and early device comparisons, in time to inform design decisions before design freeze.
Focused prototype studies and expanded feasibility evaluations.
BERLINANALYTIX
The In-Vivo
Company.
The histopathology CRO for
biomaterials & medical devices.
Specialised processing. Histological analysis.
pCROPRECLINICAL CONTRACT RESEARCH
REAL HISTOLOGY. A UNIVERSE OF QUESTIONS.
01 / STUDIES FOR YOUR PRODUCT
Your device in tissue.
Expert analysis. Clear answers.
Specialist histology for bone, collagen and bone substitute materials. Characterising foreign-body responses and implant integration in hard and soft tissue—with clear interpretation of what the findings mean for your device.
Choose the study that fits your question.
Services in focus
From implantation
to analysis.
An overview of our in-vivo, processing and histopathology services.
60 seconds · Silent film
Research Studies
Building a stronger body of preclinical evidence through larger-scale studies of implant behaviour across multiple timepoints and against predicate or reference devices.
Supporting scientific validation, FDA submissions and EU MDR technical documentation.
Material Studies
Characterising residual cellular and material components in biomaterials and evaluating the effects of processing changes.
Bone substitute materials, collagen patches and processing comparisons.
GLP Regulatory Studies
Generating preclinical evidence for regulatory submissions through GLP study conduct, quality assurance and traceable reporting.
Submission studies with full GLP documentation and oversight.
Clinical Studies
Generating histopathological evidence from clinical biopsies and explants for efficacy evaluation, clinical surveillance and post-market clinical follow-up.
Tissue response, implant integration and degradation in clinical specimens.
02 / FROM TISSUE TO EVIDENCE
What the evidence
reveals.
Understanding how your device or biomaterial interacts with tissue, changes over time and compares with a reference device.
PUBLISHED PRECLINICAL EVIDENCE
How does new bone formation compare?
Comparing two bone substitutes at 2 and 16 weeks, with tissue-level observations and measured bone formation.
A/C: xenogenic bone substitute material (XG). B/D: synthetic bone substitute material (Syn). Top: 2 weeks; bottom: 16 weeks. Asterisks: new bone; red arrows: blood vessels; CT: connective tissue. Scale bars: 100 µm.
Figure 1 reproduced unchanged from Bielenstein et al. (2022), with Mike Barbeck as corresponding author. © The authors, CC BY 4.0. Bone-area values: Table 3.
| Material | New bone |
|---|---|
| Xenogenic bone substitute material | 31.98 ± 24.83% |
| Synthetic bone substitute material | 24.10 ± 9.61% |
- The finding
- No statistically significant difference in new-bone area was reported between the materials at either timepoint.
- Relevance to your product
- Assessing bone formation alongside tissue response provides a broader basis for comparing biomaterials and defining the next study.
Rat calvarial model · 10 defect sites per material and timepoint. Absence of a significant difference does not establish clinical equivalence.
Processing and analysis
Technovit 9100 plastic embedding, H&E staining and histomorphometry. Additional CD163 and CD11c immunohistochemistry characterised selected aspects of the tissue response.
03 / THE EXPERTISE BEHIND THE EVIDENCE
From the first
question.
To the finest
section.
Study design, specialised preparation and scientific interpretation, connected around what you need to learn.
Explore the processingBLOCK TO MICROSCOPE
A glimpse into the world within.
A glimpse into the world within.
Cinematic process imagery meets authentic histology.
Specialised processing · Histological analysis
Structure preserved.
Evidence generated.
Mineralised bone. Implant interfaces. Soft-tissue architecture. Preparation built around the features your investigation needs to assess.
01 / Undecalcified bone & implants
The interface,
kept in place.
Specialised resin embedding and sectioning for bone, titanium and ceramic implants. Preserving mineralised architecture and the relationship between the implant and surrounding tissue.
- Preserved
- Cortical and mineralised structure, with the implant interface available for assessment.
- Investigated
- Bone–implant contact, bone formation, material persistence and local tissue response.
- Product relevance
- Comparative evidence on implant integration and the response to device design or material changes.
How the preparation supports the analysis
Undecalcified resin preparation retains the mineralised features under investigation. Cutting and grinding enable examination of implant-containing sections. The specimen, section orientation and study endpoints determine the preparation and subsequent histomorphometry.
02 / Soft tissue & paraffin
Tissue response,
in its context.
Paraffin processing for the tissue architecture surrounding soft-tissue implants. Assessing regeneration, matrix organisation, fibrosis and encapsulation in regenerative, cosmetic and cardiovascular applications.
The evidence: the extent and distribution of the tissue response, compared across device groups and follow-up timepoints.
Selecting the preparation
Preparation and section orientation follow the specimen and the structures being evaluated. Where mineralised tissue is present, any decalcification step is selected against the study endpoints. Soft-tissue processing does not itself require decalcification.
03 / Staining & immunohistochemistry
The stain follows
the question.
A broad histochemical and immunohistochemical repertoire, scoped to the structures and cell markers under investigation.
How does tissue composition
change across timepoints?
- Tissue architecture
- Overview stains establish morphology and the distribution of tissue around the implant.
- Matrix organisation
- Selected connective-tissue stains reveal collagen distribution and organisation for comparison across timepoints.
- Cellular response
- Study-specific marker panels characterise selected cell populations within the wider tissue response.
The evidence: tissue composition and organisation linked to the study's regeneration, integration or response endpoints.
How modalities are selected
Routine morphology, specialised histochemistry and IHC are combined where they answer the study question. Stain and marker selection, tissue preparation, controls and the analysis plan are defined together. Comparisons use the study's actual groups and timepoints.
04 / ONE COORDINATED PATHWAY
Connected expertise.
Clear responsibility.
A defined scientific contribution at every stage,
with study scope and responsibilities agreed
from the beginning.
Implantation
Focused non-GLP investigations through our integrated partner site. GLP in-vivo studies through our trusted partner network.
Processing
Specialised preparation in Berlin for hard and soft tissue, including undecalcified bone and specimens containing implants.
Analysis
Histopathology, selected quantitative readouts and scientific reporting that connect observations to your study question.
Quality requirements belong to the commissioned study.
Explore the certification and accreditation scope of our Berlin laboratory.
05 / YOUR SCIENTIFIC PARTNERS
A conversation.
With the people
doing the work.
Connect your product question with the scientists responsible for the investigation.
Meet the full team Explore our published science
Prof. Dr. Mike Barbeck
Founder & scientific leadership
Biomaterials. Tissue response.Scientific interpretation.
Dr. med. univ.
James Bielenstein
Laboratory & study leadership
Study design. Laboratory execution.Evidence and reporting.
THE NEXT QUESTION IS YOURS.
What do you
need to know?
Tell us about your device, your development stage
and the decision you want the evidence to inform.