Startup story #6 - Regenera

Spinal cord injuries, mostly of traumatic origin, are complex multi-factorial pathologies that currently impact around 250’000 new patients yearly worldwide. Regenera SA is a Swiss-Austrian medtech startup, aiming at translating into clinics its proprietary innovative combined approach for acute spinal cord injury repair. In this short interview, Giuseppe Perale, co-founder, professor at USI and serial entrepreneur, talks about the project and their recent achievements.

What does Regenera do?
We are developing a combined technology, SpinoSave®, for regenerating the acutely injured spinal cord based on a proprietary biomaterial which hosts autologous stem cells, i.e. sourced from the patient him/herself. The ensemble of hydrogel and stem cells is placed outside of the injured cord during stabilisation surgery that typically occurs within the first 24 hours after the trauma. In essence, these cells act as “medicinal cells”, meaning that they deliver certain factors to the lesioned part of the cord to stop the inflammation cascade that happens after trauma and support cord regeneration.

How did the project start?
The project stems from my academic research, which began more than a decade ago. Together with some colleagues, we had an idea to tackle this non-trivial problem, which is specifically the acute spinal cord injury, using a different paradigm. In the regenerative medicine space, biomaterials are typically used to induce stem cells to become adult specialised cells to regenerate the target tissue. Our approach is exactly the opposite. We want the stem cells to maintain their stemness and act as a local continuous secreting source of key regenerative factors.

What are your next milestones?
In February 2023, SpinoSave® was classified as an Advanced Therapy Medicinal Product (ATMP) under the subclassification of Tissue Engineered Product (TEP) by the European Medicines Agency’s Committee for Advanced Therapies (EMA CAT). In April this year, it received the orphan designation by the European Medicines Agency’s Committee for Orphan Medicinal Products (EMA COMP). These developments significantly accelerate our development plan. We hope to start clinical trials in humans in 2-3 years from now.

In your case, who is the final customer?
Our customers will be the so-called “spinal units” at the trauma centres and hospitals, where patients who have suffered spinal cord injuries of traumatic origin are typically treated. Neurosurgeons will be the end users of our technology, while the patients are the ultimate beneficiaries.  

You are not alone on this startup journey. Who else works with you on the project?
The team is crucial to the success we are having so far and is an essential foundation for our future activities. It is not a one-man show. I have the privilege of representing the team as CEO, also thanks to my previous entrepreneurial experiences. Besides me, the team is composed of Filippo Rossi, Michael Raghunath, Heinz Redl and Pietro Veglianese. Filippo is a professor at the Politecnico di Milano and we know each other since ages. He was my student during his Master's and Doctoral studies. He is the person behind the hydrogel we are using now, which he developed during his PhD. Pietro, neuroscientist and researcher at the Mario Negri Institute in Milan and visiting researcher at the NeuroRegeneration Lab (NRLab) at USI, handles the neuroscience part and the studies in animals. Michael, a Medical Doctor, joined us a couple of years ago and brings a clinical outlook to the company. Heinz Redl, former head of the Ludwig Boltzmann Research Institute, plays a less active role operationally but brings an enormous background in translating treatments from the lab to the patient. Beyond the core team, we also can count on other researchers and PhDs who are working with us on different aspects of the project.

3 quick questions to wrap it up:

• What motivates you? - The possibility to make a real difference for patients. Helping others is my ultimate motivation
• How would you describe yourself? - I am a very practical, applied researcher who enjoys translating vision into clinical reality
• Where do you see yourself in 10 years? – (laughing) I hope to be able to open an ice cream shop in a nice location