SmartCella

SmartCella, founded in 2014, is a biotechnology company built upon research from Sweden's Karolinska Institutet. The company was established by Christian Kinch, a serial entrepreneur in the pharmaceutical and medtech sectors, alongside Professor Staffan Holmin and Professor Kenneth Chien. Kinch's background includes founding Bactiguard, Netpharma AB, and Kinchard AB, bringing significant entrepreneurial experience to the venture. SmartCella operates a dual-pronged business model focused on two segments: Targeted Delivery and Regenerative Medicines. The company's strategy involves partnering with global biotech and pharmaceutical firms to bridge the gap between scientific discovery and clinical application, while also developing its own proprietary therapies. Revenue is generated through these partnerships, licensing agreements, and the future commercialization of its product pipeline.

The company's core technology in its Targeted Delivery segment is the Extroducer®, a novel endovascular infusion catheter. This device is engineered for the minimally invasive, direct delivery of a wide range of therapeutics—including small molecules, cell and gene therapies, and biologics—to hard-to-reach tissues and tumors. Developed at the Karolinska Institutet, the Extroducer utilizes an inverted Seldinger technique, navigating through blood vessels to administer treatment directly, which is designed to increase drug concentration at the target site while reducing systemic toxicity. The device has received 510(k) clearance from the FDA for applications in the abdomen and is being used in clinical trials for other organs. SmartCella forges commercial partnerships, such as the licensing agreement with XyloCor Therapeutics, to use the Extroducer for delivering gene therapy for cardiovascular disease.

In the Regenerative Medicines segment, SmartCella is developing stem cell-based therapies and modified cell-based mRNA delivery technologies. Its lead program, SMART01, uses human ventricular progenitor cells to regenerate cardiac tissue in patients with advanced heart failure and is entering a Phase 1/2a trial. The company also has a program, SMART02, focused on cell replacement therapies for Parkinson's disease, leveraging technology from the Karolinska Institutet to enhance the yield of therapeutic dopamine neurons. To support these endeavors, SmartCella has established its own GMP-certified manufacturing and quality control facility in Tullinge, Sweden, enabling the in-house production of cell therapies for clinical studies and third-party manufacturing. The company has secured significant funding to advance its operations, including a EUR 50 million share issue in July 2024 with participation from notable investors like AstraZeneca, Fjärde AP-fonden, and AMF Pension.

Keywords: targeted therapy, drug delivery, regenerative medicine, cell therapy, mRNA therapy, endovascular catheter, Extroducer, stem cell therapy, Parkinson's disease, heart failure treatment, Karolinska Institutet, biotech, gene therapy delivery, minimally invasive device, GMP manufacturing, allogeneic cell therapy, biologics delivery, solid tumor treatment, direct-to-tissue, Christian Kinch, Staffan Holmin