BerlinAnalytix — The In-Vivo Company

About / BerlinAnalytix

The specialists
behind your evidence.

Histological processing and analysis for biomaterials and medical devices. Scientific expertise, laboratory precision and quality oversight in one Berlin team.

Meet your team Inside the laboratory
Microscopy and imaging in the Berlin laboratory
Berlin, since 2018From specimen to evidence

01 / Your team

The people behind
the investigation.

Work directly with the specialists responsible for your study. From specimen preparation to interpretation, each role contributes to the evidence you receive.

Prof. Dr. Mike Barbeck
BerlinAnalytix

Founder · CEO · Principal Investigator

Prof. Dr. Mike Barbeck

Founded BerlinAnalytix in 2018. His work connects biomaterial development with histological evidence of tissue response, inflammation and regeneration, drawing on research experience in academia and industry.

Background and qualifications

Studied human medicine at Goethe University Frankfurt and Johannes Gutenberg University Mainz, where he earned his doctorate in 2014. His research focuses on biomaterial development and tissue response.

Worked at the Institute of Pathology in Mainz, led an in-vivo research group at University Hospital Frankfurt, and served as Head of Research & Development at botiss biomaterials before founding BerlinAnalytix.

Leads a research group on the biology of biomaterials at University Medical Center Rostock. His histopathological and histomorphometric research examines macrophages, multinucleated giant cells and their relationship to tissue regeneration.

Biomaterial development · Tissue response · Histomorphometry

Dr. med. univ. James Bielenstein
BerlinAnalytix

Test Facility Management

Dr. med. univ. James Bielenstein

Responsible for laboratory operations, personnel, infrastructure and quality systems. Works directly with clients on implantation study design, outcome analysis and regulatory reporting, alongside the development of digital pathology workflows.

Background and qualifications

Graduated in human medicine from Semmelweis University in 2022. His doctoral research at the University of Rostock examines in-vivo biomaterial integration and immune responses to xenogeneic and synthetic tissue implantation.

Gained clinical experience in traumatology and orthopaedics as a resident surgeon in Switzerland and worked in healthtech private equity before joining BerlinAnalytix. He is a scientific advisor to Remi Health.

Combines test facility management with a background in software development, supporting the laboratory's digital pathology and histomorphometry infrastructure.

Study design · GLP laboratory operations · Digital pathology

Dr. Kim Burckhardt
BerlinAnalytix

Principal Investigator · Soft Tissue Lead

Dr. Kim Burckhardt

Leads histological assessment of medical devices and biomaterials. Her work examines tissue–implant integration, inflammatory responses and regeneration in soft and hard tissue, including histopathological scoring under ISO 10993-6.

Background and qualifications

Holds a Master's in Biology and a doctorate in the biocompatibility evaluation of biomaterials for bone and soft-tissue regeneration. Her doctoral work evaluated bone substitute materials, barrier membranes and implantation models.

Completed a two-year pathology internship at BG Klinikum Unfallkrankenhaus Berlin, working with tissue processing, histopathology and immunohistochemistry, including inflammatory processes in human tissue samples.

Has worked as a Scientific Investigator at BerlinAnalytix since October 2022, supporting clients in interpreting biocompatibility data and preparing histopathological findings for regulatory submissions.

Tissue–implant integration · Histopathological scoring · Biocompatibility

Adrienne Rothe
BerlinAnalytix

Laboratory operations

Adrienne Rothe

Oversees day-to-day histological processing across the laboratory. Her practical experience spans paraffin, resin and ground-section workflows, matching specimen preparation to the material and the requirements of each study.

Background and qualifications

Works across the laboratory's paraffin, resin and ground-section modalities, with practical experience in selecting processing protocols for different specimen materials.

Oversees consistent specimen processing for studies ranging from proof of concept to GLP biocompatibility investigations.

Specimen processing · Resin and paraffin · Ground sections

Andrea Keding
BerlinAnalytix

Head of QM / QA

Andrea Keding

Maintains the laboratory's quality management system and internal audit programme. Supports DAkkS accreditation and GLP certification processes, with staff training and day-to-day quality management across the laboratory.

Background and qualifications

Holds an M.Sc. in Business Psychology from BSP Business School Berlin, specialising in personnel and organisational development, and a certificate in Medical Quality Management from the Bayerische Landesärztekammer.

Qualified as a Medical-Technical Laboratory Assistant (MTLA) at Ernst-Moritz-Arndt University Greifswald. Her background combines laboratory practice with quality management in medical and laboratory environments.

Served in the medical service of the German Federal Armed Forces and subsequently as Deputy Quality Management Officer at Bundeswehrkrankenhaus Berlin, supporting its DIN EN ISO 15189 quality system and DAkkS accreditation.

Quality management · Internal audits · Accreditation support

02 / The Berlin laboratory

Evidence begins with
the preparation.

Processing preserves the structures the investigation depends on. Preparation, staining and analysis are scoped to the implant, tissue and study question.

Undecalcified hard tissue

Resin embedding and precision cutting-grinding for bone, titanium and ceramic implants. Preserving cortical architecture, mineralised structures and the tissue–implant interface.

Explore hard-tissue processing

Soft-tissue processing

Paraffin processing and microtomy for soft-tissue implants and specimens. Preparing tissue for the assessment of regeneration, fibrosis, encapsulation and inflammatory response.

Explore specimen preparation

Study-specific staining

Conventional stains and immunohistochemistry selected around the study endpoints. Visualising the tissue components, cell populations and regenerative stages relevant to your device.

See what we investigate

Histological analysis

Histopathological assessment, quantitative histomorphometry and digital microscopy. Connecting tissue observations with study endpoints, timepoints and device comparisons.

Explore published evidence

03 / Quality & traceability

Scientific work.
Documented throughout.

Study requirements are matched to the applicable laboratory accreditation and certification scope. Documented methods, traceable specimens and quality oversight support the investigation.

DAkkS accredited

DIN EN ISO/IEC 17025

The laboratory’s accreditation and its defined testing scope are available in the certificate.

View accreditation & scope

GLP certified

Good Laboratory Practice

Defined responsibilities, study documentation and quality assurance for commissioned GLP investigations.

View GLP certificate

The agreed protocol defines the methods, endpoints and quality requirements of each study.

Explore the quality system (English)

Work with our team

Your study.
Our scientific team.

Bring the device, the development stage and the evidence you need next. We’ll scope the investigation with you.

Discuss your study Explore our publications