Sensome has signed an exclusive distribution agreement with Cosmotec, a company within the M3 Group, for its clot-sensing guidewire in Japan.
The smart medical device is designed to enhance mechanical thrombectomy procedures by instantly identifying clot composition and length during treatment.
Under the agreement, Cosmotec will manage the Japanese regulatory approval process for the device, which is aimed at improving ischemic stroke interventions.
Once approved by Japan's Pharmaceuticals and Medical Devices Agency (PMDA), Cosmotec will hold distribution rights in the Japanese market.
Additionally, Cosmotec has made an upfront investment in Sensome following the agreement's finalisation.
Sensome’s clot-sensing guidewire features the smallest electrical impedance sensor and uses machine learning to provide real-time data on clot characteristics.
This technology offers the potential to accurately determine clot length in fully occluded arteries and characterise clots after unsuccessful removal attempts.
The clinical trial indicated that Sensome's technology successfully met all primary safety and efficacy endpoints.
Sensome CEO and co-founder Franz Bozsak said: “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.
“We are successfully executing our initial indication in ischemic stroke and pursuing distribution relationships in other regions such as Europe, the US and China. We look forward to bringing this same momentum to other indications we are currently pursuing, including lung cancer and peripheral vascular disease.”
The clot-sensing technology, known as the Clotild Smart Guidewire System, has been recognised by the US Food and Drug Administration (FDA) as a breakthrough device.
RM Global Partners played a pivotal role as the adviser to Sensome in this partnership.
Last year, Sensome and Asahi Intecc teamed up for the development of the next-generation ClotildSmart Guidewire.
