Clinical-stage healthtech start-up Sensome has signed first distribution agreement for its smart clot-sensing guidewire technology that is used in ischemic stroke treatment.
The company signed an exclusive commercial distribution agreement with Cosmotec, an M3 Group company, to distribute its smart clot-sensing guidewire for mechanical thrombectomy in Japan.
Cosmotec also made an upfront investment in Sensome, following the finalisation of the deal.
Under the agreement, Cosmotec will take charge of all proceedings related to securing Japanese regulatory approval for the device.
Upon approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), Cosmotec will also gain distribution rights in Japan.
The Sensome clot-sensing guidewire is said to incorporate the world’s smallest electrical impedance sensor with machine learning.
The device instantly detects clot composition and length in real-time, guiding treatment decisions during mechanical thrombectomy.
Additionally, the smart guidewire aims to become the first device capable of accurately measuring clot length in fully blocked arteries in-situ, and distinguishing clots that persist after unsuccessful removal attempts.
The latest collaboration follows the presentation of positive initial clinical data last month.
According to the results, the technology met all primary safety and performance criteria during its first-in-human trials.
Sensome CEO and co-founder Franz Bozsak said: “We believe that Cosmotec is the right partner for us in Japan due to their deep understanding of the Japanese market and regulatory environment, extensive and long-standing relationships with physicians, and experience with smart medical technologies.”
Sensome’s technology utilises electrical impedance spectroscopy, which assesses the characteristics of fluid or tissue by enveloping the sensor. The data is analysed using Sensome’s proprietary predictive algorithms.
The current version of the clot-sensing guidewire is known as the Clotild Smart Guidewire System.
The Clotild Smart Guidewire System has been designated as a breakthrough device by the US Food and Drug Administration (FDA). It is still under investigation and has not received approval for commercial use in the US or any other country.
Cosmotec CEO Suguru Ominato said: “By being the exclusive distributor of this important technology in Japan, we expect to provide physicians with critical information that enables them to make the right treatment decisions that can help to improve patient outcomes after a stroke.”
