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
This press release contains forward-looking statements and forward-looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our management’s belief and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as “may”, “will”, “should”, “could”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate” or the negatives of these terms, or variations of them. Forward-looking statements are based upon a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond SoundBite Medical Solutions Inc.’s control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward looking statements. Forward-looking statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances.