SeedBlink Blog

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 studies, my best friend developed chronic pain due to a tibial nerve damage. To this day he suffers from it, and he has no solution for it (painkillers do not work).

After graduating as a biomedical engineer, I did my PhD in neural engineering and developed novel highly selective implantable electrodes for peripheral nerves.

I was part of the team that led the first worldwide studies of patients suffering from chronic pain due to damaged leg nerves. This research and development led to more than 25 publications (including Nature Medicine and Translational Science), cited more than 2500 times, and a nomination as a Top Innovator under 35 by MIT.

The feedback from patients, the media and the scientific community has been outstanding. We had a solution to an unmet need - I dedicated myself to making this solution a commercial product for patients.

What problem is SENSY solving? What kind of patients could benefit from this innovative product?

More than 20 million patients in the EU and the US suffer daily from chronic pain emanating from their hands or legs due to damage to the nerves that connect their extremities to the brain

The damage to the nerves can be caused by trauma (including amputation), metabolic diseases such as diabetes, cancer-related complications, drug poisoning, nerve entrapment, etc

They cost society $336 billion per year.

When a nerve connecting the hands or feet to the brain is damaged, sensory feedback to the brain is interrupted. The brain interprets this interruption as pain.

Available approaches (pain medications, neuromodulation devices) do not address the core of pain (interrupted sensory feedback) and therefore do not work

SENSY is an FDA-designated breakthrough device that restores natural sensory feedback to the brain to treat pain. It does this by inserting a series of micron-sized wires (half the thickness of a hair) vertically over the nerve and target. We are then able to stimulate each of the intraneural electrodes independently and selectively. This provides a number of advantages:

1. we can stimulate targeted regions that cause pain (rather than an entire limb),

2. we can completely cover the limb without causing disruptive, unnatural sensations such as paresthesias (a side effect of using spinal cord stimulators or other peripheral nerve stimulators),

3. we can restore natural sensation to a limb that is either absent (amputees) or numb (diabetic feet)

Feedback from 7 patients who have participated in previous clinical trials shows that the benefits are immense. They (upper limb) can now distinguish between soft and round objects and even different textures. Lower limb amputees can feel every bump on the ground when walking, which reduces their falls, cognitive load, and overall metabolic consumption. All patients who suffered from pain reported a reduction in pain (down to 0) in less than one month. You can read more in the following articles:

• Nature Medicine - Sensory feedback restoration in leg amputeesimproves walking speed, metabolic cost andphantom pain.

• Science Translational Medicine - Enhancing functional abilities and cognitive integrationof the lower limb prosthesis

• Annals of Neurology - Six-Month Assessment of a Hand Prosthesiswith Intraneural Tactile Feedback

• Customer Testimonials

Intellectual property and regulation are two strategic pillars for any MedTech company. What is SensArs' status in these two areas?

SensArs' implantable electrode (the core of SENSY) is patented in the US (US10974043B2) and the EU (EP3522773B1). These patents are broad in scope, i.e., they protect applications/indications other than sensory nerves (e.g., stimulation of the motor nerve, vagus nerve, hypoglossal nerve, etc.) Future submissions will address:

• additional features we have added to our electrode: Anchoring system for fixation of intraneural wires

• aids for implantation

• IPG

On the Quality/Regulatory side, the main milestone achieved was the completion of an internal Quality Management System (QMS) that meets the requirements of ISO 13485, MDR and FDA. Processes were defined and SOPs were signed. In addition, preliminary meetings were held with the FDA to align and confirm the development and testing approach for future clinical trials in the US. Finally, our SENSY system was granted Breakthrough Device Designation. This will allow us to accelerate market availability and patient access to our technology.

Next steps include:

- Preparation of technical documentation for submission to regulatory agencies mentioned in the clinical section above - April 2023

- Conclusion of a contract with a selected Notified Body in Europe - Q3 2023

We have in-house expertise to lead these activities, including world-class consultants to provide additional review and support.

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 damage due to amputations by introducing them to the SENSY system. These results were beyond our imagination.

We demonstrated that implantation was safe for up to 6 months, no adverse events occurred, and nerve functionality remained unchanged for up to 2 years after the end of the clinical trial

We have demonstrated that our novel electrode can restore natural sensory feedback to patients' missing extremities. Restoring natural sensory feedback to the brain eliminated pain after only one month of therapy and allowed patients to feel their prosthesis and improve their movement control

With these results, we published more than 25 articles in peer-reviewed medical journals and made it to the front pages of Nature and Science.

What qualities do you think are essential in the MedTech sector to be successful?

Resilience to changes in regulatory framework and supply chain management.

Knowledge of the steps required to achieve approval for commercialization (quality, regulatory, development, manufacturing) in a timely and cost effective manner

Creativity in finding solutions to challenges related to regulatory pathway and supply chain management

Our core team (myself, Guy, Dan and Magdalena) was carefully assembled in pursuit of these qualities.

What is happening in the industry you work in? What are the key trends in neuromodulation?

Neuromodulation has relied on the same technologies (spinal cord stimulation) or indications (back pain) for the past 20 years.

The trend now is toward new technologies that are data-driven and new indications. SensArs is a perfect opportunity for this trend - our intra-nerve stimulation is creating a new paradigm in the chronic pain marketplace.

This is because we are the only device that targets nerves with high precision and reaches every extremity of the body, while we also we regenerate sensory feedback and treat pain.

This new paradigm makes us a category creator in an understudied and high demand market

We target a 28% unserved market totaling 67 million patients in the EU and US, costing society $1.2 million annually.

Additionally, SENSY collects patient gait data and pain reports that update therapy without physician intervention.

What is your biggest challenge in scaling?

The challenge with scaling starts with the design process. You need to make sure you design for manufacturing from the start (DFM), and that's exactly what we do. We incorporate design considerations such as material selection, production techniques and assembly processes at the prototype stage.

For example, we manufacture the implant's housing using silicone injection molding, and although we currently only need tens to hundreds of units, we can scale up to thousands of units very quickly.

Another challenge is finding the right partners to allow us to scale up production quickly when the time comes. We have assigned these partners, such as Med-Ally, who have the facilities and infrastructure to realize larger production volumes.

Where do you see SensArs in 3-5 years?

With market approval in Europe and the U.S. by 2025, we will begin commercialization. We will first approach Germany and Italy, where we will have conducted our clinical trials, we already have a reimbursement code (Germany) and discussions with INAIL (Italian institution for reimbursement of occupational injuries). Then we will move into the Northern European countries, as they have a favourable reimbursement policy. Then we will enter the other European markets and the USA. Our goal is to reach 600 patients and 10 million euros in sales by 2027

In parallel, we want to test the feasibility of different approaches in animal studies without deviating from the main strategy of market approval for pain treatment/sensory restoration: Brain-computer interfaces, rehabilitation, sleep apnea, diabetes/obesity treatment.

This will increase Sensars' valuation for acquisition, which we are targeting for 2025 when we will have results from large clinical cohort studies. An acquisition is forecast because spinal cord stimulator manufacturers (Medtronic, Boston Scientific, Abbott) are looking to add our product to their portfolio to serve the currently unserved chronic pain market due to nerve damage.

What makes SensArs so special? Why should investors choose you?

Our team consists of global innovators who have already completed all steps from development to market approval in the EU and the USA. We have already secured future customers (surgeons from centers in Europe and the US, e.g. Policlinic Gemelli, Charite Berlin, Barolat Institute, MUSC, WashU). We are supported by specialized investors in medical technology such as Occident, Wille, Liftt, ZKB.

We are like Neuralink, but for the nerves: our technology is highly innovative, it can be implanted in the nerve in less than 10 minutes through a standardized procedure under local anesthesia.

The market for chronic pain due to nerve damage (e.g., after amputations, diabetes, cancer complications) is unappreciated and represents an opportunity of approximately $350 billion. The leaders in chronic pain will want to add our product to their portfolio to take advantage of this opportunity (about 30% of the total market).

Chronic pain is just the beginning. Our electrode can be implanted in any nerve in the body. We will cure diseases such as sleep apnea, diabetes, obesity, and motor impairments due to strokes. Our future preclinical and clinical studies are backed by studies on over 40 animals and 7 humans.

SensArs is currently raising a private Series A round on SeedBlink.