Hello Francesco, you are the founder and CEO of Sensars today, but we are curious about your background. What experiences led you to become a MedTech startup entrepreneur?
During my university studies, my best friend developed chronic pain due a damage to the tibial nerve. To this day, he still suffers for this and he has no solution for that (pain killers do not work).
After graduating as a biomedical engineer, I have completed a PhD in neural engineering, developing novel highly selective implantable electrodes for peripheral nerves. I was part of the team that led the first worldwide studies with patients affected by chronic pain due to damaged leg nerves. This research and development led to over 25 publications (including Nature Medicine and Translational Science) cited 2500+ times, and top innovator under 35 nomination from MIT.
The feedback from the patients, the media and the scientific community was outstanding. We had a solution for an unmet need.
I engaged in the mission of taking such solution to a commercial product for patients.
What problem is SENSY solving? What kind of patients could benefit from this innovative product?
Over 20 million patients in EU and USA are suffering on a daily basis from chronic pain originating in their hands or legs due to damages to the nerves that connect their extremities with the brain.
The damage to the nerves may result from trauma (including amputation), metabolic diseases such as diabetes, cancer-related complications, drug intoxication, nerve entrapment, etc…
The cost to society is $336 billion per year.
When there is a damage to a nerve connecting the hands or feet with the brain the sensory feedback loop to the brain is disrupted. The brain interoperates this disruption as pain.
Available approaches (pain killers, neuromodulation devices) do not address the core of pain (disrupted sensory feedback) thus do not work.
SENSY is an FDA breakthrough designated device that restores the natural sensory feedback with the brain thus treating the pain. This is done through an array of micron-size wires (half the thickness of hair) that are inserted vertically across the nerve and target. We are then able to stimulate each of the intraneural electrodes independently and selectively.
This provides a multitude of advantages:
1) We are able to stimulate specifically the regions that cause pain (not an entire limb),
2) We are able to get full coverage of the limb without inflicting disturbing, unnatural feelings such as paresthesia (a side-effect when using spinal cord stimulators or other peripheral nerve stimulators),
3) We are able to restore natural sensation to a limb that is either not there (amputees) or is senseless (diabetic feet).
Feedback from 7 patients that participated in earlier clinical trials, testifies that the benefits are immense. They (upper limb) can now distinguish between soft objects, round objects and even different textures. Lower limb amputees can feel every bump on the ground as they walk, reducing their falls, cognitive burden and overall metabolic consumption. All that were suffering from pain have reported reduction of pain (up to 0) within less than a month. More can be read in the following articles:
SensArs’ mission has a social impact. How did the human testing go? Is it how you’ve imagined it?
We had the opportunity to improve the lives of 7 patients with nerve damages due to amputation by introducing them to the SENSY system. These results went beyond our imagination. We demonstrated safety of the implantation up to 6 months and no adverse events and nerve functionality unchanged up to 2 years after the end of the clinical study.
We also demonstrated that through our novel electrode, natural sensory feedback can be restored from the missing extremities of patients. The restoration of natural sensory feedback to the brain removed pain after only one month of therapy and allowed patients to feel their prosthesis and increase their movement control.
With these results we published 25+ articles in peer-reviewed medical journals, making the cover of Nature and Science.
What is happening in the industry you work in? What are the key trends in neuromodulation?
Neuromodulation has been relying on the same technologies (spinal cord stimulation) or indications (back pain) for the last 20 years. The trend now is to identify novel technologies that are data-driven and novel indications.
SensArs is a perfect opportunity for this trend:
Our Intra-nerve stimulation creates a new paradigm in the chronic-pain market. That is because we are the only device able to
a) have highly precise nerve targeting & reach every extremity of the body,
b) thus, we regenerate sensory feedback and treat the pain.
This new paradigm makes us a Category-Creator in an under-penetrated & high-demand market. We are targeting a 28% unattended market of a total of 67M patients in EU and USA that cost $1.2T per year to society.
Additionally, SENSY collects patients’ gait data and pain reports that update the therapy without the need of the intervention of the doctor.
Where do you see SensArs in 3-5 years?
With a market approval in Europe and USA by 2025 we will start commercialization. We will address first Germany and Italy where we will have executed our clinical studies, we have already a reimbursement code (Germany) and discussions with INAIL (work accident reimbursement national Italian institution). Then, we will penetrate the northern European countries for their favourable reimbursement policies. Then we will enter the other European markets and the USA. We aim at reaching 600 patients and 10M eur revenues by 2027.
In parallel, our plan is to test in animals, the feasibility of several approaches, without diverging from the main strategy of getting market approved for pain treatment/sensory restoration: brain computer interfaces, rehabilitation, sleep apnea, diabetes/obesity treatment.
This will increase Sensars’ valuation in view of an M&A that we envision for 2025 when we will have results from large cohort clinical studies. An M&A is forecasted because spinal cord stimulator manufacturers (Medtronic, Boston Scientific, Abbott) will want to add our product to their portfolio to address the currently unattended market of chronic pain due to nerve damages.
What makes SensArs so special? Why should investors choose you?
We are like Neuralink but for the nerves: our technology is highly innovative, it can be implanted inside the nerve in less than 10 minutes through a standardized procedure, under local anaesthesia.
The market of chronic pain due to nerve damages (e.g. after amputation, diabetes, cancer complications) is unattended and represents an opportunity of about $350 billion. Chronic pain market leaders will want to add our product to their portfolio to manage to penetrate such opportunity (about 30% of the whole market).
Chronic pain is only the beginning. Our electrode can be implanted in any nerve of the body. We will cure diseases such as sleep apnoea, diabetes, obesity, motor impairments due to stroke.
Our future preclinical and clinical studies are derisked by studies in 40+ animals and 7 humans.
We have already secured future customers (surgeons from centers in Europe and USA, eg Policlinic Gemelli, Charite Berlin, Barolat institute, MUSC, WashU).
Our team is constituted by worldwide innovators, that have already executed all the steps from development to market approval in EU and USA. We are backed up by specialized investors in medtech such as Occident, Wille, Liftt, ZKB.