adMare Portfolio Company Receives FDA 510(k) Clearance
January 21 2020
adMare BioInnovations Portfolio Company SoundBite Receives FDA 510(k) Clearance of the SoundBite™ Crossing System – Peripheral
MONTREAL – SoundBite Medical Solutions Inc. (SBMS)today announces it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the SoundBite™ Crossing System, a unique active wire technology for use in the treatment of peripheral chronic total occlusions (CTOs).
“Through our collaborative approach with the FDA, we met the regulatory requirements and transformed a novel technology into a commercial product,” said Marc-André Côté, Director, Regulatory Affairs of SoundBite.
FDA 510(k) clearance indicates that the product complies with the requirements of 21 CFR 807 Subpart E and is authorized to be distributed and commercialized in the USA market.
“This significant milestone is very gratifying for all SoundBite employees who deployed an incredible amount of dedication and effort to make it happen. This also allows us to bring this innovative treatment solution to clinicians and their patients suffering from difficult-to-treat calcific PAD (Peripheral Artery Disease) in the US,” said Francis Bellido, CEO of SoundBite.
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 (mandy.dilazzaro@soundbitemedical.com) or Francis Bellido, CEO (francis.bellido@soundbitemedical.com), SoundBite Medical Solutions, 2300 Alfred Nobel, Technoparc St-Laurent, Montreal Québec H4S 2A4
For additional information visit www.soundbitemedical.com
Forward-Looking Statements
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.
