LEIPZIG, GERMANY – July 29, 2025 – BIONCaRT GmbH, a biotech company focused on developing cell therapies for orthopedic diseases, today announced strategic collaborations with Bramble Bio, a Contract Development and Manufacturing Organization (CDMO) specializing in cell and gene therapies and part of the FamiCord AG, and the Fraunhofer Institute for Cell Therapy and Immunology (IZI). These partnerships will be instrumental in the manufacturing of BIONCaRT’s lead product, MesemCartTM, the first allogeneic stem cell therapy for the treatment of knee cartilage damage in Europe.

Under these agreements, Bramble Bio will be responsible for the manufacturing of the MesemCart drug substance, utilizing their expertise in advanced therapy medicinal product (ATMP) process development and manufacturing, and the Fraunhofer IZI will fill of the final drug product for the upcoming clinical trial.

BIONCaRT is preparing to initiate a Phase I/IIa clinical trial to evaluate the safety and initial efficacy of MesemCartTM for patients suffering from cartilage damage in the knee joint. This trial is being conducted in close collaboration with eight renowned clinical trial centers.

“We are delighted to be partnering with Bramble Bio and Fraunhofer IZI, two leading organizations in the cell therapy manufacturing space,” said André Gerth, Founder and CEO at BIONCaRT. “Their combined expertise and cutting-edge facilities are crucial to ensuring the high-quality production of MesemCartTM as it advances into clinical trials. This collaboration brings the potential of offering patients with debilitating knee cartilage damage a much-needed regenerative treatment option.”

“At Bramble Bio, our mission is to support innovative companies like BIONCaRT in bringing transformative cell and gene therapies to patients,” stated Simon Boa, Managing Director at Bramble Bio. “The collaboration on the manufacturing the drug substance of MesemCartTM aligns perfectly with this mission, and the company is excited to contribute its expertise to the development of this promising allogeneic cell therapy.”

The Phase I/IIa clinical trial, at Carl Gustav Carus University Hospital, Dresden, is expected to begin recruiting patients towards the end of 2025.

About BIONCaRT GmbH:
BIONCaRT GmbH is a research-based pharmaceutical company focused on the development and manufacturing of cell therapy products from mesenchymal stromal cells (MSCs) for clinical application in humans, particularly for the treatment of orthopaedic diseases. Their lead product, MesemCart™, is an allogeneic cell therapy for articular cartilage regeneration.

About Bramble Bio:
Bramble Bio is a leading Contract Development and Manufacturing Organization (CDMO) specializing in providing comprehensive services for the cell and gene therapy industry. They offer expertise in ATMP process development, optimisation and cGMP manufacturing. Bramble Bio is part of FamiCord AG.