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SoundBite Medical Solutions Announces Successful Completion of its Pivotal PROSPECTOR Clinical Study at TCT Conference in San Diego

MONTREAL - SAN DIEGO – September 25th, 2018 – SoundBite Medical Solutions Inc. (SBMS) announced last Friday at TCT (Transcatheter Cardiovascular Therapeutics), a major conference in the Interventional cardiology space, that its Pivotal PROSPECTOR prospective, single-arm clinical trial using SoundBite’s shock wave energy system has been completed. Fifteen subjects suffering from Peripheral Arterial Disease (PAD) with chronic total occlusions (CTOs) were treated at two sites (Montréal and Ottawa) with a clinical success rate of 93% and no serious adverse events were reported. Dr. Eric Therasse Professor at the Department of Radiology, Radio-Oncology and Nuclear Medicine at the University of Montreal (CHUM), Principal Investigator of the PROSPECTOR Clinical Trial and presenter at TCT, declared, “The technology showed an excellent efficacy and safety profile in treating a wide...

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SoundBite Medical Solutions Announces the Start of its ACTIVE Coronary CTO Pivotal Clinical Study

MONTREAL – September 21st, 2018 – SoundBite Medical Solutions Inc. (SBMS) announced today the successful start of its ACTIVE Trial, a recently approved study by Health Canada with the objective to demonstrate the potential of the SoundBite™ Active Wire to cross coronary chronic total occlusions (CTOs). The first two patients who underwent this new procedure were treated by Dr. Stephane Rinfret, MD, SM, FRCPC, Chief of Interventional Cardiology at the McGill University Health Center (MUHC) in Montreal and principal investigator for the ACTIVE Trial. “Our team, at the MUHC is proud to be involved in the first coronary CTO crossing application of the revolutionary new SoundBite shock wave system. The positive results obtained with the first two patients launch this determinant clinical trial in the...

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SoundBite Medical Solutions Named Company of the Year 2018 by Anges Québec

MONTREAL – June 22nd, 2018 – SoundBite Medical Solutions Inc. (SBMS) has been selected as Company of the Year by Anges Quebec. “We are very honored to be named Company of the Year 2018 by Anges Québec,” said Francis Bellido, SoundBite President & CEO. “This award highlights the exciting growth we’ve achieved as a key player in the field of CTOs and vessel prep and recognizes the excellent work of our greatest asset, our employees. I also want to thank Anges Quebec members for their indefectible support since the beginning of the company.” The trophy was presented to SBMS during a ceremony in Saint-Jean-sur-Richelieu, last Thursday. About SoundBite Medical Solutions SoundBite is a privately-held medical device company developing products in the field of vessel preparation for the management and...

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SoundBite Medical Solutions Completes $25 million Series A Financing

MONTREAL - June 12th, 2018 – SoundBite Medical Solutions Inc. (SBMS) today announced the closing of a $5.2 million second and final tranche of Series A financing, bringing the total proceeds raised in the Series A financing to $25 million. In April 2018, SBMS closed a first tranche of Series A financing, led by Fidelity Investments Canada ULC. The second tranche included existing shareholders as well as new investors. SBMS intends to use the new capital to further advance its clinical and product development programs over the next 30 months. This includes the ongoing pivotal clinical programs for the SoundBite™ Active Wire in the coronary and peripheral indications, as well as a First-In-Man clinical trial for the SoundBite™ Active Microcatheter. SoundBite™ Active Wire received...

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SoundBite Announces Successful Series A Financing and the Appointment of a New CEO

MONTREAL - April 10th, 2018 – SoundBite Medical Solutions Inc. (SBMS) today announces the closing of a $19.9 million Series A financing, with a possibility of raising more funds in a second tranche later in the quarter. This round of financing included participation by new and existing Canadian and international investors, including Fidelity Investments Canada ULC. These new cash proceeds will be used to prepare for a strategic commercial launch in Europe after recently obtaining CE Mark approval. In addition, it will allow the company to complete a First-In-Man clinical trial for the SoundBite™ Active Microcatheter and to accelerate its pivotal clinical development plan in order to achieve FDA approval for the peripheral and coronary chronic total occlusion (CTO) indications within the next 30 months. “The...

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SoundBite announces CE Mark Approval for SoundBite™ Crossing System – Peripheral

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...

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SoundBite is Named One of 2017’s Best Scientific Discoveries by Québec Science Magazine

MONTREAL January 30th, 2018 – SoundBite Medical Solutions Inc. (SBMS), has been selected as a finalist in the 2017 “Discovery of the Year” contest by Québec Science Magazine. The discovery has been named top 10 within Québec out of the 124 applications it received. SoundBite was selected on the basis of an article describing its first-in-human case: “Novel crossing system for chronic total occlusion recanalization: First-in-man experience with the SoundBite crossing system, Benko et al., Journal of Invasive Cardiology 29(2):E17-E20” and the award of a patent covering its core technology: “Mechanical wave generator and method thereof, Brouillette et al., U.S. Patent 9,833,373.” Every fall for the last 25 years, Québec Science has been selecting the 10 most notable Québec discoveries of the year through a...

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SoundBite Announces Successful Completion of First-In-Man Clinical Study for Peripheral Chronic Total Occlusions (CTO) Crossing Procedures

MONTREAL – December 20th, 2017 – SoundBite Medical Solutions Inc. (SBMS) announced today that its First-In-Human prospective, single-arm and multi-center clinical trial using SoundBite’s shock wave energy system has been successfully completed. Thirty-seven (37) patients suffering from chronic total occlusion (CTO) were treated in three sites (Montréal, Sherbrooke and Graz (Austria)) with a clinical success rate of 92% and no serious adverse events. Dr. Andrew Benko, Chief of Angiography and Endovascular Therapy at the Sherbrooke University Hospital (CHUS) and Principal Investigator of the clinical trial, stated, “This technology fulfills an important need in the field of CTO intervention as it can convert failed procedures into successes, giving the patient relief from ischemic pain and even saving their limb”. In total, 41 lesions from 37 patients were treated...

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SoundBite announces new CEO

MONTREAL, July 28 2017 – SoundBite Medical Solutions Inc. (SBMS), a Montreal-based cardiovascular medical technology company, is pleased to announce that Martin Brouillette, Co-Founder and Chief Technology Officer, has been named Chief Executive Officer. Martin is the one of the inventors of Soundbite’s proprietary technology and has been instrumental in all aspects of the company's development to date including the recent First-in-Human trial. Martin has also spearheaded pre-clinical developments, driven the widening of the company’s products portfolio and was a key player in Soundbite’s very successful $15M Seed Round financing. Martin will lead SoundBite to maximize its potential in developing not only treatments for interventional vascular care but also in the much larger field of vessel preparation, leveraging his strong technical expertise and leadership. He succeeds...

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SoundBite Announces the Hiring of Abder Benrabah to the position of Vice-President, Quality Engineering and Assurance

MONTREAL, March 1st, 2017 – SoundBite Medical Solutions Inc. (SBMS Inc.), a Montreal-based cardiovascular (CV) medical technology company, is pleased to announce its recent hire of Abder Benrabah, an industry Quality Assurance (QA) and Regulatory Affairs (RA) leader in medical devices. Mr. Benrabah will join the SBMS team as Vice-President Quality Engineering and Assurance, to lead the quality function of SoundBite’s shockwave technology in the exciting and challenging arena of chronic total occlusions (CTOs) of the cardiovascular system. Mr. Benrabah brings over twenty-six years of leadership experience in various fields, including medical devices. He has held various management positions in QA, RA and Continuous Improvement at CryoCath Technologies, Biorthex Inc. & PerkinElmer BioSignal. Abder joins SBMS Inc. from Smith & Nephew Inc. where he...

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