MONTREAL March 27th, 2018 – SoundBite Medical Solutions Inc. (SBMS) today announces it has received CE Marking for the SoundBite™ Crossing System, a unique and novel first-in-class wire-based technology that is intended for the treatment of peripheral chronic total occlusions (CTOs) in a simpler and clinically efficient method.
“We are pleased that our notified body verified that we have objectively demonstrated the safety and efficacy in Europe of our CTO crossing technology through bench and clinical studies,” said Marc-André Côté, Director, Regulatory Affairs, “and that we were able to demonstrate the effective tracking of our activities in an ISO 13485-certified quality management system,” added Abderrahim Benrabah, Vice-President, Quality Engineering.
CE Marking indicates that the product complies with the Essential Requirements of the 93/42/EEC Directive and is authorized to be distributed and commercialized in the European market.
“The CE marking is the culmination of our efforts to engineer and manufacture a product that satisfies all the European requirements for a medical device,” said Domenic Santoianni, Director, Product Development.
“The award of our first CE Mark is a significant milestone for the Company,” said Co-Founder and CEO, Martin Brouillette, “and is the direct result of the tenacious efforts and exemplary dedication of our excellent team of employees.”
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 further information on SoundBite Medical Solutions, please contact: Martin Brouillette, CEO (email@example.com) or Francis Bellido, CFO (firstname.lastname@example.org), SoundBite Medical Solutions, 2300 Alfred Nobel, Technoparc St-Laurent, Montreal Québec H4S 2A4
For more information, visit www.soundbitemedical.com
Across CTOs — Safe and Sound.