MONTREAL – February 3, 2020 – SoundBite Medical Solutions Inc. (SBMS) announced today that it has received FDA IDE (Investigational Device Exemption) approval to start the ACTIVE Clinical Study with the SoundBite™ Crossing System – Coronary in the USA, a unique and novel active guidewire technology for use in the treatment of coronary chronic total occlusions (CTOs).
“After the recent 510(k) clearance for our SoundBite™ Crossing System – Peripheral, we are very pleased with this FDA approval which allows us to accelerate the development of the coronary application for our active wire technology in the USA, and to bring patients and physicians an innovative new tool to address calcific difficult-to-treat CTOs,” said Francis Bellido, CEO of SoundBite Medical.
FDA IDE Approval indicates that SBMS has provided sufficient data to support initiating an IDE to evaluate the safety and effectiveness of the SoundBite™ Crossing System – Coronary through a multi-center study in the US as well as Canada, where the study has already started.
About SoundBite Medical Solutions Inc.
SoundBite Medical Solutions Inc. is developing proprietary shock wave technology to address significant unmet clinical needs in interventional vascular treatment. Through an elegant combination of hardware and software, it can, in a very controllable manner, deliver high amplitude shock wave pulses through guidewires and other interventional tools, to specifically attack highly calcified and fibrotic tissue in the vascular system, while leaving healthy, elastic arterial walls unharmed.
For information on SoundBite Medical Solutions, please contact Mandy Di Lazzaro, Director, Human Resources & Communications ([email protected]) or Francis Bellido, CEO ([email protected]), SoundBite Medical Solutions, 2300 Alfred Nobel, Technoparc St-Laurent, Montreal Québec H4S 2A4
For additional information visit www.soundbitemedical.com
Forward-Looking Statements
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