Lorenzo Rossi, CEO,

Newronika

"DBS delivers high-frequency stimulation that decreases the activity of specific brain targets, thus reducing the symptomatology of Parkinson’s with incredible results."

Newronika is a spin-off from the Hospital Maggiore in Milan and the University of Milan. What led to the creation of Newronika? The project that was later to take shape as Newronika was started within the neurological department of the hospital and under the mentorship of Professor Alberto Priori, a leading figure in the field of neuromodulation. We started with a system for non-invasive stimulation back in 2005, developing the concept solely for internal research rather than with a goal to define a patent. For the next five years, we operated a virtual company, outsourcing the production and distribution of the device. Because the product was seeing good sales, we reinvested the margins to fund a new idea; an implantable system capable of reading brain activity and also adjusting the stimulation to treat movement disorders – the most common of which being Parkinson’s Disease. The idea was taken to maturity and we built the company in 2017 after a first-round fundraise. We became one of the first centers in the world to use Deep Brain Stimulation (DBS) as a treatment. Newronika is developing the first functionally integrated technology into the brain. Can you explain the functions of the Alfa DBS system and the Web Biobank? DBS was invented about 20 years ago and it was designed to replace a surgical approach that involved the ablation -or the burning - of the tissue in Parkinson’s patients. DBS delivers high-frequency stimulation that decreases the activity of specific brain targets, thus reducing the symptomatology of Parkinson’s with incredible results. However, there are limitations to this technique: the DBS technology delivers a constant treatment, left at the same amplitude for years without adjustment, just like the first cardio-pacemakers would do. We developed the decoding of the brain signals to understand whether a patient is responding well or if we need to adjust the stimulation. We record the signals after the implantation of the electrode after just a few days, and only then do we implant the IPG (implantable pulse generator). The Web Biobank is a collection of signals recorded at different centers over the past 20 years. Through this, we solved a fundamental technical issue: it is very difficult to stimulate using the same electrode because this makes significant noise when it delivers the stimulation. Using electronic hardware and signal processing, we have an upgraded implantable system tested already in 14 people, and currently undergoing further clinical investigation. What is the universe of application for your biosignal decoding brain devices? The universe of application goes beyond Parkinson’s and movement disorders, and I believe neuromodulation and bioelectrical medicine could be one of the big possibilities for the future of medicine. Neuromodulation is already being used in the symptom management of pain or for psychiatric disorders like depression, via the stimulation of the spinal cord or the motor cortex. What are the main trends in the advancement of the DBS field? R&D in this field is divided in three streams: first, there is a trend to develop better leads (the electrodes implanted in the brain), be it in terms of their manufacturing quality, reliability, or the number of contacts they use. The second stream relates to targeting or the technology to place the electrode in the right position; neuronavigation, imaging, and pretty much everything that will help the neurosurgeon to implant with greater precision and speed falls under this category. Currently, the process is quite long and requires that the patient stays awake throughout the procedure, which can take many hours. Finally, the most predictable R&D trend is the focus on the closed-loop approach. What is your financing strategy and what is the timeline of development you’re looking at now? Newronika has raised 12 million euros, money invested to begin the pilot study in Europe. For Q1 2022, we are looking at another financing round to help us fund the testing of the system on a large population of Parkinson’s patients as part of a study designed together with the FDA. A typical Series B funding, this will aim at around 20 million euros. Neuromodulation is an attractive investment opportunity and there is a vibrant scene of companies making similar devices.

image