With the news in recent days of the second patient in the world to receive a pig heart transplant, “Health and Biomedical” is once again proving to be one of the most productive fields, both in terms of application and research. Experts from the University of Maryland School of Medicine performed this operation for the second time.
The case of Lawrence Faucette, the 58-year-old man who underwent the operation and who is currently undergoing anti-rejection therapy, is one of the many significant examples of the impact of scientific research in the field of medical devices, including those dedicated to organ transplantation. Impact not only generated by overseas laboratories. Italy is also experiencing significant growth and development in this area. An example of this is “BIOLAB PERFUSOR”: a medical device for mechanical perfusion born in the laboratories of the Università di Firenze thanks to the work of Mattia Dimitri, Fabio Staderini, Lucrezia Mazzantini, Sara Aquino, Andrea Corvi, Fabio Cianchi and Federico Linari.
The patent confirms the importance of the development of the biomedical sector in Italy. The tracking data of the Knowledge Share platform is the talk of the town. In fact, ‘BIOLAB PERFUSOR’ is the most viewed patent for ‘Sanità e Biomedicale’ for the month of August. To find out more, we interviewed Mattia Dimitri, researcher at Università di Firenze.
Tell us about yourself, your background and your role/interests in the world of research.
I have always been a curious student from the beginning of my university studies. I started my academic career in Mechanical Engineering, but already in my second year I began to contaminate my studies with the rudiments of robotics and automation, and then continued with a Master’s degree in Mechanical Engineering, delving into planetary gears and the complex dynamics of ground vehicles, and finally finishing my course with a thesis and a company internship, where I ventured into the design of structural and functional parts of an ultra-light helicopter. Even today, when I think back, I smile at all the times I literally catapulted myself out of my comfort zone. When I was offered the opportunity to apply for a PhD in Industrial Engineering, I naturally chose to apply for an ambitious project in the field of bioengineering, in which I still have a strong interest: The development of a non-invasive ultrasound treatment to selectively destroy pancreatic cancer cells by exciting them at their resonance frequency. Today I am a researcher at Università di Firenze and I can say that in all my academic years I have had the opportunity to work side by side with extraordinary professors and colleagues from whom I have always tried to learn something new. I believe that it is thanks to their teaching that today I have been able to put together a multidisciplinary team such as the one that has created “BIOLAB PERFUSOR” and which I am sure will be able to carry out research on devices for organ perfusion and transplantation at an increasingly high level. I would also like to emphasise that this project could only be born from a heterogeneous team that reflects the image of biomedical engineering, where mechanical, electronic, computer and management skills come together to create new, increasingly complex and sophisticated devices capable of opening up new avenues for the science of life.
The ‘BIOLAB PERFUSOR’ project: from idea to market potential.
The ‘BIOLAB PERFUSOR’ project was created with the primary objective of meeting the experimental needs for the development of energy surgical devices. In particular, the BIOLAB PERFUSOR is designed to reproduce and maintain the physiological conditions of blood pressure and temperature of animal organs over time.
The use of a device with these capabilities allowed us to carry out an experiment to validate the results of microwave thermoablation with blood circulation, which led to an effective development beyond all expectations. In fact, the device is not only able to reproduce the effects of energy subtraction for the duration of a standard thermoablation process (which varies from 10 to 30 minutes), but also allows the organ to be perfused for over 4 hours without causing any obvious damage to the vessels or vascular trees.
Since this initial experience, the team has focused a great deal on the project, investigating and integrating the device components necessary to guarantee correct monitoring not only of the temperature of the perfusion fluid but also of the circulation pressure, oxygenation of the perfusate and filtering to avoid occlusion of the vessels due to the presence of any clots.
The research work made it possible to conduct an experiment to compare with devices already on the market and to validate the perfusion efficacy of the device developed by testing the viability of different types of organs that were subjected to treatment for an indicative time of 4 hours and for which samples were taken in both normothermia and hypothermia. At the same time, we also received a positive opinion for the patent filing, which therefore motivated the entire team to continue improving the product and the perfusion process.
How does “BIOLAB PERFUSOR” work and how does it improve on the status quo of current technologies?
In general, the use of organ perfusion can help to increase the number of organs available for transplantation in several ways.
The first is by extending their shelf life. Perfusers can keep organs in optimal temperature and oxygenation conditions for a longer period of time than traditional cold storage. This can extend the window in which the organ can be transplanted.
The quality of the organ is then improved. The use of perfusors can improve the quality of the donor organ by reducing cell damage and preserving organ function during storage. This can increase the success rate of transplants and the lifespan of the transplanted organ.
A third issue is the expansion of the donor pool. Because perfusion devices can improve the quality and suitability of organs from marginal donors or donors who have died of cardiac arrest, they may allow more organs to be used that would otherwise have been considered unsuitable for transplantation.
Finally, the treatment of damaged organs must also be considered. Some perfusors allow drugs and treatments to be administered directly to organs during the perfusion process, which may help to salvage organs that would otherwise be discarded due to injury or pre-existing conditions.
BIOLAB PERFUSOR can perfuse in both hypothermic (low temperature) and normothermic (body temperature) conditions, providing a significant competitive advantage in the field of organ transplantation. This is possible thanks to a heat exchange system developed by the R&D team and constantly updated to ensure greater reliability and efficiency.
The first advantage is undoubtedly the flexibility of the BIOLAB PERFUSOR”. This type of perfusor allows doctors to adapt the treatment to the specific needs of the donor organ. For example, some organs may benefit from normothermic perfusion for functional recovery, while others may require hypothermic perfusion: the choice of perfusion mode allows the quality and functionality of the organ to be improved.
The second advantage is undoubtedly the extension of the useful window for transplantation. The perfusion process, with temperature cycles adapted to clinical needs, makes it possible to extend the duration of preservation and, consequently, to increase the recovery of organs from distant donors or to better coordinate transplants in the event of logistical complexity.
It should also be noted that temperature is not the only parameter that can be monitored, the perfusor’s sensors can also be used to monitor parameters such as venous and arterial pressure, the possible presence of clots, organ surface moisture and the oxygenation level of the perfusate, making the device versatile and suitable for many types of clinical research.
Progress of the project to date and plans for the future: what are you looking for? Have there been requests for applications in other types of transplantation besides liver transplantation (if possible as a process)?
The project so far is at an exploratory stage in several areas of application. We are also investigating its use in pharmacology, for testing on marginal organs with the aim of fully restoring them for subsequent transplantation. Given the nature of the perfusion platform, which allows both hypothermic perfusion at 4°C and normothermic perfusion at 37°C, we are receiving many requests from clinicians to perform experiments with our device or to adapt it according to their needs, in order to better understand which extracorporeal perfusion process is most appropriate depending on the conditions and the type of organ to be perfused.
Spin-off or no spin-off? If no, why? If yes, with whom (investors/industrial partners?) How much would you need in economic terms?
Spin-off is certainly an option that the team is considering. We strongly believe that the university can provide substantial support, especially in the development phase of the start-up.
In this phase, it is essential to structure the company in a robust way, aimed at fully exploiting the technology developed and the know-how of the partners to transform it into a quality product for the target market.
Università di Firenze, which currently owns and commercially exploits the patent for the machine, is certainly the first option. We are also negotiating with venture capitalists in the sector who could help us with industrial development on a larger scale.
In economic terms, the indicative cost of bringing a first machine to market is estimated at 5,000,000 euros, which would cover all the development, testing, certification and production phases.
Have you made contacts thanks to the Knowledge Share platform? What do you expect from such a platform?
At the moment we have not received any contacts from the Knowledge Share platform, but we expect that investors who want to know more about the device we have developed will contact us with a view to establishing broad industrial and healthcare development agreements.
Read more about ‘BIOLAB PERFUSOR: ‘BIOLAB PERFUSOR’ – Medical device for mechanical perfusion | Knowledgeshare (knowledge-share.eu)
“BIOLAB PERFUSOR” Research Team