Rachel Klemovitch, Assistant Editor07.10.24
Sensome has entered into an exclusive distribution agreement with Cosmotec in Japan for the smart clot-sensing guidewire used in mechanical thrombectomy.
Cosmotec will assume responsibility for all activity associated with the Japanese regulatory approval process and receiving the distribution rights in Japan upon regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the device.
The Agreement follows a presentation of positive first-in-human clinical data for the Sensome clot-sensing guidewire last month at the international LINNC Paris 2024 conference. 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 ischemic stroke,” said Franz Bozsak, 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.”
The clot-sensing guidewire uses the world’s smallest impedance sensor with machine learning and is being developed to identify clot composition and clot length in real time to inform treatment approaches during mechanical thrombectomy.
This guidewire has the potential to be the first device to accurately identify clot length in fully occluded arteries in-situ, and the first to characterize clots that remain in the body after failed removal attempts.
Japan’s Ministry of Health, Labour and Welfare estimates there are approximately 15,000 thrombectomy cases performed each year in Japan, presenting a significant opportunity for Sensome’s technology.
“We are impressed with Sensome’s unique clot-sensing guidewire and its potential to characterize clots in patients who are undergoing life-saving stroke treatment,” said Suguru Ominato, CEO of Cosmotec. “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.”
“We are successfully executing on our initial indication in ischemic stroke and pursuing distribution relationships in other regions, such as Europe, the U.S., and China. We look forward to bringing this same momentum to other indications we are currently pursuing, including lung cancer and peripheral vascular disease,” Bozsak concluded.