Ischemic stroke is the leading cause of long-term disability worldwide, affecting over 13 million people each year and costing tens of billions of dollars. Sensome, a French medtech that offers connected medical devices, has developed micrometric AI-powered impedance sensors that can identify the biological nature of the tissue they touch in real-time. Integration of this proprietary technology into a probe to guide medical devices in arteries (a guidewire) has given rise to Sensome’s first product, Clotild®, which recognizes blood clot types in ischemic strokes so clots can be treated faster to improve patients’ chances of a full recovery. The Sensome technology also helps transform the current standard of care in oncology.
SEMI spoke with Franz Bozsak, CEO and co-founder of Sensome, about innovative medical technology trends and how microelectronics plays a crucial role.
SEMI: When did your adventure with Sensome start?
Bozsak: My former Ph.D. advisor Abdul Barakat and I spun-out Sensome from the Ecole Polytechnique in Paris in early 2014 after receiving a 200.000 Euro grant from the French government. We then developed a micrometric impedance sensor that coupled to machine-learning algorithms to identify biological tissues on contact. We are still integrating this sensing technology with existing medical devices in order to create a new category of smart medical devices that provides physicians with relevant insights during their interventions and treatments. These additional insights aim to render healthcare treatments more effective by reducing the risk of complications and the cost of interventions while improving patient monitoring.
SEMI: How are strokes typically treated?
Bozsak: Before 2014 the almost exclusive way of treating ischemic stroke was by injecting tissue plasminogen activator (tPA) intravenously in order to chemically dissolve an arterial clot. This treatment approach has severe limitations and can only be used in the first 4.5 hours following the onset of a stroke. In 2015, several randomized clinical trials demonstrated the efficacy of a new treatment modality: mechanical thrombectomy.
Medical devices that allow a clot to be removed mechanically either using a grid-like structure (a stentriever) or by aspirating the clot using an aspiration catheter completely changed the paradigm in the treatment of ischemic stroke for up to a third of all patients. This new intervention removes the clot in up to 90% of all cases and can for certain patients be used up to 24 hours after the onset of the stroke.
Mechanical thrombectomy is now one of the most effective medical treatments in the world. The clinical data gathered over the past years also shows that, in order to maximize the patient’s chances to lead a life free from disability after a stroke, it is not only a question of getting the clot out but also about how the clot was removed. Removing the clot on the first attempt significantly increases the patient’s chances of recovery – the first-pass-effect that is now the objective when treating ischemic stroke patients. And this is exactly where Sensome wants to help since clot removal after several attempts increases risk for patients.
SEMI: How did you improve mechanical stroke treatments?
We have integrated our sensor technology into a guidewire, the first device to enter a patient’s blood vessels for navigation to the clot. Once in place, the smart guidewire – called Clotild® – guides the thrombectomy device to provide the physician with information on the clot to help the physician choose the thrombectomy device with the highest chances of achieving the first-pass-effect.
SEMI: Medical technology has made astonishing advances over the years. How did Sensome develop the micrometric AI-powered impedance sensors?
Bozsak: The development of a product like Clotild® would have not been possible five years ago, and many people considered what we wanted to achieve simply incredible. Today, we can answer those same people: We knew it was almost impossible and therefore we just did it. By combining diverse semiconductor technologies, we were able to build the smallest impedance meter in the world. This was then integrated into a guidewire that can be connected via a transmitter to a tablet that serves as the interface with the physician. The guidewire provides impedance measurements that can be analyzed by a machine-learning algorithm, which in turn identifies the tissue in contact with the sensor. A very diverse team of people, collaboration and several different disciplines such as micro-electronics, data science, biology and engineering were required to make this happen.
Our ambitious team has been able to flourish and accomplish their ideas in the very stimulating and resourceful environment of the Ecole Polytechnique, while being embedded into the rich and fertile start-up ecosystem of Paris. It is the combination of all these factors taken together that have made our innovation possible.
SEMI: What are the main challenges and what are the market opportunities?
Bozsak: Bringing semiconductor technology into the medical field is not a straightforward process. The primary hurdle is the simple fact that medical device production volumes are not comparable with consumer electronics volumes and that development cycles are much longer due to regulatory constraints. Both factors are, at first sight, not necessarily compatible with today’s business model of the semiconductor industry. At the same time, this is also a unique opportunity for the semiconductor industry to diversify and expand into a new field – sensors and, in particular, their seamless integration into the healthcare workflow, are a key driver for the healthcare sector of the future. And to achieve this objective, semiconductor technologies are key. What is beneficial, in my opinion, is that the quality standards and requirements of the semiconductor industry are highly compatible with the needs of the medical device industry.
SEMI: Are market fragmentation and the high level of regulation making medtech innovation harder?
Bozsak: Both are challenging but very rewarding to pursue since the impact on a patient’s life can be profound. Innovation is harder because many stakeholders are involved in ensuring the success of a medical device launch. The involved, milestone-driven, highly regulated process of developing a medical device and bringing the device to the market assures its eventual success. The development process differs very much from those for normal consumer devices. In our case the beneficiary, the patient, is not necessarily the user of the device but rather the physician. The physician is not necessarily the buyer of the device, but the hospital. The hospital is not necessarily paying the device, but ideally the government.
The interests of all these stakeholders need to be satisfied to bring a successful device to the market.
SEMI: What are your expectations regarding the future of medtech digital innovation?
Bozsak: This is the right moment for the medical device and semiconductor industries to come together. The healthcare sector is not low on medical needs for which innovative ideas exist, and the semiconductor industry has many technologies that can enable these ideas to generate solutions. But to make this happen, both sectors need to collaborate. Working together requires both sides to understand their respective needs and constraints. The earlier the knowledge exchange starts, the more powerful the solutions. SEMI MedTech Forum at SEMICON Europa last year was a wonderful opportunity for Sensome to get this discussion going. We are looking forward to continuing the exchange and push the frontiers of the possible further to create the future of digital healthcare.
Franz Bozsak, CEO and co-founder at Sensome, obtained a M.S. in Aerospace Engineering from the University of Stuttgart and a Ph.D. from the Ecole Polytechnique in Biomedical Engineering on the optimization of stents. He is a graduate of the Stanford Ignite/Polytechnique business program. In 2014, he co-founded Sensome and has since built a team of renowned scientists, engineers and doctors to realize his vision of connected medical devices. He was named Innovator Under 35 by the MIT Technology Review in 2016.
Serena Brischetto is a marketing and communications manager at SEMI Europe.