SmartCella ramps up efforts in targeted delivery and precision medicine
– Our business is divided into two operating segments: Targeted Delivery and Regenerative Medicines, explains Ricardo Baptista, CTO* at SmartCella.
Targeted Delivery includes the Extroducer®, an endovascular delivery device for direct injection of therapeutics to hard-to-reach reach tissues, organs and tumors.
Regenerative Medicines has two areas. The first is modified cell therapies which include cell-mediated delivery of mRNA and development of novel mRNA therapies, with a focus on cartilage regeneration for osteoarthritis. The second includes cell therapies covering stem/progenitor cell therapies derived from human pluripotent stem cells, targeting multiple therapeutic areas including heart failure and Parkinson’s disease.
Founded in 2014, SmartCella is based on Swedish innovation and globally renowned science and research from Karolinska Institutet. They are a team of approximately 80 employees representing 28 different nationalities and have two facilities:
- Headquarters in Tullinge, near Karolinska University Hospital and the Flemingsberg Life Science cluster.
- A facility for early discovery and translational research at the Karolinska Institutet campus in Solna, in central Stockholm.
– We would also like to highlight SmartCella’s Scientific Advisory Board, which held its inaugural meeting in 2025 under the leadership of our board member, Professor Anna Martling. The board brings together leading global scientific and clinical key opinion leaders who advise us on innovation, operational efficiency, healthcare economics, sustainability, and most importantly, how we can improve patient outcomes across the healthcare system. They provide valuable scientific and clinical insights and help guide our strategic direction, supporting both our research programs and the continued commercialization of the Extroducer®, says CEO Niklas Prager.
What problems do your products solve?
– Let us start with Targeted Delivery. Most advanced therapies are still given systemically, which often cause side effects, weak tissue penetration, dose-limited efficacy, and unwanted accumulation in organs like the liver and lungs. The modality-agnostic Extroducer® is designed to solve these issues by enabling targeted, minimally invasive delivery into difficult-to-reach organs and tumors. Today, pharmaceutical developers of advanced modalities are prioritizing precise delivery technologies like the Extroducer® to achieve effective drug concentrations in target tissues while avoiding systemic side effects, says Ricardo Baptista.
Within Regenerative Medicines, they are developing cell-based therapies for three major conditions that currently have no disease-modifying treatments available: heart failure, Parkinson’s disease, and osteoarthritis.
– In essence, SmartCella is focused on addressing unmet medical needs and shaping the future of targeted therapies with the goal of delivering truly life-changing treatments for patients, says Niklas Prager.
What are the biggest challenges in this market?
– The key challenges come primarily from the complexity of clinical development in general. Advancing any therapeutic candidate involves scientific, regulatory, and operational challenges. To mitigate this, our strategy focuses on non-exclusive licensing and diversified partnerships, enabling us to run multiple projects in parallel and reducing reliance on any single program. Another challenge is achieving robust and economically viable manufacturing. Today’s manual and labor-intensive processes limit reproducibility, increase costs, and complicate GMP execution. We address this by investing in next-generation, automated, and scalable processes that meet regulatory standards while lowering costs, says Ricardo Baptista.
– Together, these approaches help us navigate sector challenges and build a more resilient, capital-efficient development model, says Niklas Prager.
What does the future look like for SmartCella, what is the next step?
– Our overarching strategy is to partner with global biotech and pharmaceutical companies across all development phases. Through our different platforms, we target companies of all sizes and across any development phases. Our role is to bridge the translational gap from early scientific discoveries to clinical application, keeping the commercial product and patient outcomes in mind already from the start, says Niklas Prager.
There are a lot of activities ongoing across their operating segments. Their pipeline of proprietary programs nearing their final stages before entering clinical trials in humans is strong. This includes SMART01, a cell therapy for patients suffering from heart failure, with a Phase I/II trial programmed to start in early 2026, and SMART02, a dopamine cell replacement therapy for Parkinson’s disease.
– We are also in the final stages of preparing a Phase I/II clinical trial for patients with inoperable pancreatic cancer. This trial will utilize the Extroducer® to deliver chemotherapy directly into pancreatic tumors and is being conducted in close collaboration with Karolinska University Hospital, says Ricardo Baptista.
– In addition, our platform for delivery of mRNA therapies inside of stem cells has yielded promising pre-clinical results, with both pain relief and regeneration of cartilage in animal models of Osteoarthritis (SMART03). This is a significant result as Osteoarthritis affects a growing group of patients globally due to an aging and increasingly sedentary population. Osteoarthritis is a major cause of disability without curative treatments, and the potential for a disease-modifying therapy is very significant continues Ricardo Baptista.
Are there any collaborations that you would specifically like to highlight?
– SmartCella signed a licensing agreement in July 2024 with the US biotech company XyloCor Therapeutics, granting XyloCor a non-exclusive license to use the Extroducer® as a delivery technology for their lead clinical asset XC001, says Niklas Prager.
– We have collaborated with XyloCor on the submission of the clinical trial applications and conducting clinical trials in the US and Europe in the XC001 program, which relates to treatment of refractory angina, a chronic heart condition, in a double-blinded Phase IIb clinical trial. An important milestone was reached earlier this year with the first patient dosed in the study. The partnership with XyloCor validates the commercial potential of the Extroducer® for future non-exclusive licensing partnerships, Niklas Prager continues.
How do you view SmartCella's role in the global ecosystem for targeted delivery and precision medicine?
– As already mentioned, our strategy is to partner with global biotech and pharma companies, serving as a partner in bridging the translational gap from early scientific discovery to clinical application. Through non-exclusive license agreements of the Extroducer® delivery platform to biotech and pharma companies across all development phases we believe we can play an important role in advancing and accelerating the development of precision medicine and targeted delivery of therapies, says Niklas Prager.
– Our goal is to revolutionize the treatment of diseases that have previously been incurable, such as cardiovascular diseases and cancer, Niklas Prager concludes.
*CTO: Chief Technology Officer
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