Lindis Blood Care GmbH

About Lindis Blood Care

Lindis Blood Care GmbH is a MedTech/biotechnology company founded in 2018, headquartered in Hennigsdorf near Berlin. The company develops and markets medical products based on its patented ABCR-T platform (Antibody Based Cell Removal Technology) for the removal of tumor and immune cells from blood. The first product, CATUVAB®, removes EpCAM-positive tumor cells including tumor stem cells from the surgical blood of oncological procedures, thereby enabling safe autologous retransfusion without irradiation. A CATUVAB® kit consists of a trifunctional antibody, buffer solution, sterile single-use components and a leukocyte depletion filter (LDF) and is compatible with standard cell saver systems (intraoperative blood salvage); up to 3 liters of salvaged blood can be processed per kit. Clinical efficacy was demonstrated in the multicenter REMOVE study (136 patients, 6 centers), with final results published in the Journal of Clinical Anesthesia. The CE certification process is ongoing, the FDA submission was made in 2024; target markets are the EU, the USA and prepared expansion into Asia.

Site

Hennigsdorf

Processes

ABCR-T (Antibody Based Cell Removal Technology): trifunctional antibodies bind and aggregate, Intraoperative Blood Salvage (IBS) / Machine Autotransfusion (MAT) – processing and safe, Development and marketing of the medical device CATUVAB® for the removal of tumor cells from, ABCR-T technology platform (Antibody-Based Cell Removal), Business development / licensing and distribution partnerships

Materials

Trifunctional (bispecific) antibody against EpCAM-positive tumor cells, Red blood cell concentrate (autologous, salvaged blood), Buffer solution for CATUVAB® kit, Trifunctional antibody (EpCAM-targeted), Leukocyte Depletion Filter (LDF), Buffer solution

Certificates

CE certification process (MDR), FDA submission, Clinical validation (REMOVE study)

Founded

2018

Industries

MedTech, Biotechnology, Blood management / transfusion medicine, Oncology

1. 01

   Cell cultivation and manufacture of the trifunctional antibody (ABCR-T)

2. 02

   Assembly of the sterile single-use kit (antibody, buffer solution, syringes,

3. 03

   Quality testing and release of the medical device

4. 04

   Application at standard IBS/cell saver systems in the hospital

5. 05

   Aggregation of tumor and immune cells by the antibody

6. 06

   Removal of the cell aggregates by filtration

7. 07

   Retransfusion of the autologous red blood cell concentrate

Technology & Mode of Action

Locations

Hennigsdorf

DE

Company headquarters, development and regulatory processes

Products & Kits

Inside the production

Processes & technical limits

2 Anlagen & Maschinen

Quality & Regulatory Compliance

Clinical validation was performed in the multicenter REMOVE study with 136 patients at 6 centers; CE certification under the EU Medical Device Regulation is ongoing, and the FDA submission was filed in 2024.

Company History

1. 2018

   Founding of Lindis Blood Care GmbH including seed investment by Dr. Franzpeter Bracht and Dr. Horst Lindhofer

2. 2019

   Raising of €5.5 million in capital

3. 2020

   Completion of the pilot ex-vivo study

4. 2021

   Start of the multicenter EU certification study REMOVE in March

5. 2022

   Second capital increase

6. 2023

   Completion of the multicenter confirmatory study; last patient of the REMOVE study completed in December; €1.5 million capital raised

7. 2024

   Start of the CE certification process (Q1), FDA submission (Q4); final REMOVE results published in the Journal of Clinical Anesthesia

8. 2025

   EU launch of CATUVAB® expected in Q4