Sensome has announced an exclusive distribution agreement in Japan with Cosmotec, an M3 Group company, for its smart clot-sensing guidewire used in mechanical thrombectomy. Cosmotec made an upfront investment in Sensome upon finalising the agreement, as noted in a recent press release.
Under the terms of the agreement, Cosmotec will assume responsibility for all activity associated with the Japanese regulatory approval process for the device—which is intended for use in ischaemic stroke treatment—and receive distribution rights in Japan upon regulatory approval from the country’s Pharmaceuticals and Medical Devices Agency (PMDA).
According to the company, Sensome’s clot-sensing guidewire integrates the world’s smallest electrical impedance sensor with machine learning, and is being developed to instantly identify clot composition and clot length, in real time, in order to inform treatment approaches during mechanical thrombectomy. The smart guidewire has the potential to be the first device to accurately identify clot length in fully occluded arteries in situ, as well as the first to characterise clots that remain in the body after failed removal attempts, the release adds.
The agreement follows presentation of positive first-in-human clinical data for the Sensome clot-sensing guidewire at last month’s LINNC Paris conference (3–5 June 2024, Paris, France). The study demonstrated that the technology met all primary safety and performance endpoints of the trial.
“The commitment by Cosmotec to lock in distribution rights for our smart clot-sensing guidewire in Japan clearly demonstrates their confidence in Sensome and enthusiasm for our proprietary tissue-sensing technology that holds significant potential to improve the treatment of ischaemic stroke,” said Franz Bozsak, chief executive officer (CEO) and co-founder of Sensome. “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. We are successfully executing on our initial indication in ischaemic stroke and pursuing distribution relationships in other regions, such as Europe, the USA and China. We look forward to bringing this same momentum to other indications we are currently pursuing, including lung cancer and peripheral vascular disease.”
“We are impressed with Sensome’s unique clot-sensing guidewire and its potential to characterise clots in patients who are undergoing life-saving stroke treatment,” Suguru Ominato, CEO of Cosmotec, added. “Clot composition and length are not readily determined today, leading to a majority of thrombectomy cases requiring multiple passes, which adds risk, and the failure of up to 20% of cases to remove the entire clot. 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.”
RM Global Partners LLC served as advisor to Sensome for this deal, the release also states.
