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SoundBite Announces Health Canada Approval of the SoundBite™ Crossing System – Peripheral

MONTREAL December 4, 2019 – SoundBite Medical Solutions Inc. (SBMS) is pleased to announce that it has received a Health Canada Medical Device License for the SoundBite™ Crossing System – Peripheral. “We are pleased to have obtained our first approval in North America for the clinical use of the SoundBite™ Crossing System – Peripheral and thank the employees, clinicians, patients and other stakeholders that made this possible,” said Francis Bellido, CEO of SoundBite. “This approval allows us to commercialize this innovative technology in its country of origin, Canada, which will also facilitate our ability to pursue approval in other countries.” 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...

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SoundBite Medical Solutions Inc. and Asahi Intecc Sign Distribution Agreement for Japan

Asahi Intecc will be Exclusive Japanese Provider of the SoundBite™ Crossing System – Peripheral MONTREAL – December 3, 2019 – SoundBite Medical Solutions Inc. (SBMS) has signed an exclusive distribution agreement with Asahi Intecc Co., Ltd. (“Asahi Intecc”) to sell its SoundBiteTM Crossing System in Japan. Asahi Intecc is recognized globally as a leading manufacturer and provider of guidewires and catheters among other medical devices used by hospitals for cardiovascular interventions in over 108 countries and regions across the globe. “We are excited to build on our strategic partnership with Asahi Intecc and to bring the SoundBite system to patients suffering from peripheral vascular disease in Japan. We look forward to this collaboration and to leveraging Asahi Intecc’s market leadership and experience to expand our...

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SoundBite Medical Solutions Announces $8M Loan Agreement with Investissement Québec

MONTREAL – September 24, 2019 – SoundBite Medical Solutions Inc. (SBMS) today announced that it has entered into an $8 million loan agreement (the “Agreement”) with Investissement Québec (IQ) as part of the Biomed Propulsion Program. The terms of the Agreement were not disclosed. SoundBite intends to use the proceeds to support the development and early market introduction of its SoundBiteTM Crossing System (SCS). The first application, the SCS-Peripheral has received CE Mark, and SoundBite has filed for market authorization in Canada and the US. The Biomed Propulsion Program, which is under the responsibility of the “Ministère de l’Economie et de l’innovation du Québec” is administered by IQ. “We are excited to have the support of Investissement Québec, a high-profile Canadian investment institution, as...

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SoundBite Medical Solutions Announces New Appointments to its Board of Directors

MONTREAL – September 23, 2019 – SoundBite Medical Solutions Inc. (SBMS) today announced the appointments of William L Hunter, MD, Azin Parhizgar, PhD and Rick Geoffrion to the Board of Directors. “We are extremely excited and pleased to welcome these three medical device industry veterans. Their deep business expertise in Interventional Cardiology will be invaluable to SoundBite and we are confident that their broad experiences with both emerging and multinational healthcare companies will significantly strengthen and extend the reach of our Board,” said Dr. Francis Bellido, President and Chief Executive Officer of SoundBite Medical. “We are also very pleased that Dr. Hunter has accepted to act as Chairman of the Board,” added Dr. Bellido. Bill Hunter, MD is Founder, President & Chief Executive Officer of Canary...

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SoundBite Medical Solutions Was Honored with the “Prix Genie innovation 2019” by the Order of Engineers of Quebec

MONTREAL – June 6, 2019 - SoundBite Medical Solutions Inc. (SBMS) today announced that Martin Brouillette, Cofounder & Chief Technology Officer, along with the SoundBite Team, was honored with the “Prix Genie innovation 2019” at the 15th “Soirée de l’Excellence en génie” on Wednesday, May 29, 2019, at Salon 1861 in Montréal. The goal of the Prix Génie Innovation is to encourage innovative engineering by recognizing its value both in terms of the results achieved and the efforts made. This year the SoundBite Team was awarded this prize in recognition of the SoundBite system development, which represents a major innovative breakthrough in CTO treatment resulting in improved crossing success rate and patients’ quality of life. “This award is the direct result of the efforts and dedication of...

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SoundBite Medical Solutions Announces the Presentation of Their Technology During an Episode of the Show “Découverte” on ICI Radio-Canada Télé

MONTREAL - February 19, 2019 - SoundBite Medical Solutions Inc. (SBMS) today announced that their shockwave technology was presented on Sunday evening by Dr. Stephane Rinfret, MD, SM, FRCPC, Chief of Interventional Cardiology at the McGill University Health Center (MUHC) on a science television show called “Découverte.” "We are delighted that our technology has attracted so much attention from a show as prestigious as "Découverte." The program provides an excellent explanation of the therapeutic challenges posed by calcified chronic total occlusions. I think that the public will appreciate this fine example of Quebec creativity and its potential to solve a significant unmet medical need," said Francis Bellido, President and CEO of SBMS. Link to watch this episode: https://ici.radio-canada.ca/tele/decouverte/site/segments/reportage/106268/ondes-choc-artere (at 34: 07/42: 42) About SoundBite...

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SoundBite Medical Solutions Announces the Resignation of Steven Arless as Chairman of the Board of Directors

MONTREAL January 31, 2019 – SoundBite Medical Solutions Inc. (SoundBite) announced today that Steven Arless has resigned as Chairman of the Board of Directors. Effective February 1, 2019, Steven Arless, Co-Founder and Chairman of the Board of SoundBite will relinquish his role as Director representing the Founders and, as a result, his role as Chairman of the Board. Mr. Arless has decided to pursue his other interests in teaching (Professor of Practice, Faculty of Medicine, McGill University) and in building a Medtech Start-up Ecosystem at one of Canada’s largest and fastest growing accelerators, Montreal-based Centech. He is also co-founding two other MedTech start-ups in the Montreal region. Steven Arless says: “As one of the Company’s co-founders, I would like to thank Martin Brouillette and my other co-founders, Louis-Philippe...

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SoundBite Medical Solutions Announces Having Received CE Marking for its SoundBite™ Crossing System Peripheral Gen 2

MONTREAL – December 18, 2018 – SoundBite Medical Solutions Inc. (SBMS) announced today that it has received CE Marking for its SoundBite™ Crossing System Peripheral Gen 2, an improved version of its shockwave-based technology platform that is intended for the treatment of peripheral Chronic Total Occlusions (CTOs). 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 award of this CE Mark is another significant milestone for the Company and will allow us to begin our commercial activities with an improved console and guidewire, starting in Europe and later in North America,” said Francis Bellido, President and CEO of SBMS. About SoundBite Medical Solutions SoundBite is a privately-held medical...

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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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