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December 4, 2019

SoundBite Announces Health Canada Approval and Japanese Distribution Agreement for Peripheral Crossing System

December 4, 2019—SoundBite Medical Solutions announced that it has received a Health Canada Medical Device License for the company's SoundBite crossing system–peripheral. This approval allows the company, which is based in Montreal, Quebec, to commercialize the technology in Canada. The company noted that the approval will also facilitate its ability to pursue approval in other countries.

On December 3, SoundBite announced that Asahi Intecc Co., Ltd. will be the exclusive distributor in Japan of the SoundBite crossing system–peripheral. Asahi Intecc is a leading global manufacturer and provider of guidewires and catheters among other medical devices used by hospitals for cardiovascular interventions in over 108 countries and regions across the globe.

The SoundBite crossing system–peripheral is used to facilitate the intraluminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions. The device consists of a reusable console and a disposable wire, the company noted.

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